Comparative evaluation of efficacy of Pippalyadi Agada as an adjuvant drug vs. standard drug therapy in the management of acute food poisoning: A Study Protocol

Vitthal Shinde; Nilima Wadnerwar

doi:10.12688/f1000research.141879.1

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Study Protocol

Comparative evaluation of efficacy of Pippalyadi Agada as an adjuvant drug vs. standard drug therapy in the management of acute food poisoning: A Study Protocol

[version 1; peer review: 3 approved with reservations]

Vitthal Shinde ¹, Nilima Wadnerwar¹

PUBLISHED 23 Apr 2024

Author details Author details

¹ Department of Agadtantra, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India

Vitthal Shinde
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Nilima Wadnerwar
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Antimicrobial resistance, a pressing challenge in modern medicine, arises from excessive antibiotic use in veterinary and human care. Underreporting and complex links between food contamination and illnesses have led to underestimating foodborne disease impacts. The World Bank’s 2019 analysis projected $15B annual treatment costs and $95.2B productivity loss in low- to middle-income countries due to foodborne diseases. “Agada” refers to symptom-relieving medications, like “Vishaghnakalpa.” Pippalyadi Agada, from Vishaghana plants, treats “Dooshivisha Chikitsa,” e.g., Kitibha, rashes, shwas. It has anti-inflammatory, antioxidant properties, aiding acute food poisoning with nausea, vomiting, fever, diarrhea. It is a carminative, curbing prolonged diarrhea, and anti-toxic. Pippalyadi Agada pacifies imbalanced Vata and Kapha, promising better relief than Agni and Pittastana interventions. As an Ayurvedic remedy, it is administered as Vati, 500mg twice daily with Anuapan Honey for 7 days. This study aims to comparatively evaluate the effectiveness of Pippalyadi Agada as an adjunct to standard drug therapy in managing acute food poisoning. Following a comprehensive drug analysis, a total of 60 eligible participants will be selected and assigned to two groups, each comprising 30 individuals. Group A will receive standard drug therapy, while Group B will receive standard drug therapy alongside Pippalyadi Agad, administered twice daily for 7 days. Assessments will occur on days 0, 3, 5, and 8, both before and after the intervention. The study anticipates that the use of Pippalyadi Agada as an adjunct to standard drug therapy will lead to improved symptom relief and faster recovery in individuals with acute food poisoning, as demonstrated by significant reductions in symptoms such as nausea, vomiting, fever, and diarrhea. The observed outcomes will contribute to a more comprehensive understanding of the potential benefits of Ayurvedic interventions in managing foodborne illnesses.

Keywords

Agad, Dushi Vish, Virudha Ahar, Acute food poison, Pipplyadi guggul, Standard drug therapy.

Corresponding author: Vitthal Shinde

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Shinde V and Wadnerwar N. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Shinde V and Wadnerwar N. Comparative evaluation of efficacy of Pippalyadi Agada as an adjuvant drug vs. standard drug therapy in the management of acute food poisoning: A Study Protocol [version 1; peer review: 3 approved with reservations]. F1000Research 2024, 13:361 (https://doi.org/10.12688/f1000research.141879.1) First published: 23 Apr 2024, 13:361 (https://doi.org/10.12688/f1000research.141879.1) Latest published: 23 Apr 2024, 13:361 (https://doi.org/10.12688/f1000research.141879.1)

Introduction

In ancient Ayurvedic texts, food’s medicinal attributes are likened to those of drugs. Properly consumed, food becomes a healing remedy, as emphasized by a Shloka. Tailoring our diet to our individual physiology and adhering to a Sattvik (life-supporting) regimen enhances digestion and benefits our bodies.¹

According to a Shloka (cha.su.5/3-4), the “Matra” or quantity of diet should not harm and varies with the strength of digestive fire (agni).² This varies based on seasons and age. Digestive fire strength dictates periodic adjustments in diet quantity. It is essential to ingest food as per individual stomach capacity and agni strength, ensuring that the quantity does not disturb equilibrium. Optimal intake bestows strength, vitality, speech, happiness, and nourishment.³

Modern lifestyles vary due to occupation, leading to frequent consumption of incompatible or junk foods. In Ayurveda, “Viruddha Aahara” - an unsuitable diet - contributes significantly to health issues. Dushivisha investigation reveals that incompatible foods play a role. While diet is vital, consuming it correctly is equally crucial to sustain health. An unhealthy diet becomes detrimental, potentially causing long-term diseases. Ancient Acharyas described non-effective diets as “DushiVisha,” demonstrating the critical link between diet and health.⁴

Dushivisha stems from factors disturbing dhatus, like dushit desha, kala, food, diwaswap, and triggers both dushivisha and acute food poisoning. Over 200 diseases, from cancer to diarrhea, result from tainted food containing harmful bacteria, viruses, parasites, or chemicals. This cycle of disease disproportionately affects vulnerable groups. Poisons affect dhatusamya, leading to various illnesses. Foodborne illnesses, contagious or toxic, arise from microorganisms or chemicals entering the body.⁵

"Annapanamavishad rakshetra vikshenamahipate" (Shlok No.2, annasamrakshaneeya, Ashtanga Hridaya by Vaghbhat, Sutrasthana) advises protecting food from contamination that may increase all doshas. Ayurveda details symptoms and treatments for contaminated foods like rice, fruits, meat, etc.⁶

Food poisoning, despite its discomfort, remains a global concern. The WHO reports 420,000 annual deaths and 600 million illnesses due to tainted food, causing substantial DALYs. Hazardous food costs $110 billion annually in low- and middle-income nations. Children under five suffer 40% of foodborne disease impact, hindering socio-economic progress and straining health systems, trade, and economies.⁷

In the India Region, nearly 150 million people suffered foodborne illnesses in 2010. Unsafe food extends beyond safety to include unhealthy fats, high energy density, and excessive salt, heightening non-communicable disease risks.⁸

Street food, popular yet risky due to contamination, poses health hazards through viral and bacterial transmission. Ancient medicine harnessed plant-derived compounds, though some proved toxic. Ayurveda employed detoxification (shodhana) to render these compounds safe for use. Shodhana, encompassing more than purification, mitigates poisons’ effects.⁹ From poison contact routes, dietetics is a focal point. Garavisha involves long-term intoxication through combined food and drinks. Charaka emphasizes not just food, but water too, as integral to diet in the Annadravadravyavijnaniya chapter.

Objective

1. To study the efficacy of Pippalyadi Agada as an adjuvant drug in the management of acute food poisoning.
2. To compare the efficacy of Pippalyadi Agada as adjuvant therapy and standard drug therapy in acute food poisoning patients.
3. To evaluate analytical profile of Pippalyadi Agada.

Case definition

The food should be protected from getting contaminated. It may increase all the doshas namely vata, pitta, kapha. All dosh as when increased at the same time requires effortful treatment for attaining the equilibrium. Ayurveda explains that symptoms like dryness of mouth, restlessness, sweating, tremor, loss of stability during walking ayurved explains symptoms and treatment for contamination of different types of food like rice, fruits, meat etc. The acute food poisoning can be confirmed by the assessment of patient and history of food consumption with history of symptoms of Nausea, Vomiting, Diarrhoea (Bristol stool criteria), Fever, Abdominal Pain, and Degree of Nausea and vomiting rating. Also, the objective criteria are of CBS, LFT, KFT, STOOL R/M can be assessed by getting the laboratory results.¹⁰

Research question

Is Pippalyadi Agada as an adjuvant therapy more efficacious as compared to standard drug therapy in patients with acute food poisoning?

Alternative hypothesis (H1)

The adjuvant drug Pippalyadi Agada demonstrates greater efficacy compared to standard drug therapy in patients with acute food poisoning.

Null hypothesis (H0)

Pippalyadi Agada is not more efficacious than standard drug therapy in patients with acute food poisoning.

Methods

Trial design

This study employs a randomized controlled trial design, specifically a single-blind parallel design. It is an interventional study with a balanced 1:1 ratio allocation to two groups, as outlined in Table 1. Two Groups each with minimum of 30 patients.

Table 1. Intervention plan.

Group	Sample size	Intervention	Dose and frequency	Anupan	Duration
Group A	30	Standard drug therapy	Tab O2 (200 mg/500 mg)	Water	7 Days
			Tab Dompan (10/20 mg)
			Tab Cyclopam 1 tab SOS
Group B	30	Standard drug therapy and Tab Pippalyadi Agad (Adjuvant drug)	Tab O2 (200 mg/500 mg)	Water	7 Days
			1 tab twice a day
			Tab Dompan (10/20 mg)
			1 tab twice a day
			Tab Cyclopam 1 tab SOS and	Honey
			Tab. Pippalyadi Agada (500 mg)	Honey

Study setting

The study will take place within the CASUALTY, OPD, and IPD units of MGAC & Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe) in Wardha.

Registration

The registration process is currently in progress.

Inclusion criteria

1. Individuals willing to provide informed written consent.
2. Individuals aged between 18 to 50 years, of either sex.
3. Participants exhibiting history and symptoms of acute food poisoning, including nausea, vomiting, diarrhea, fever, and abdominal pain.

Exclusion criteria

1. Individuals below 18 and above 50 years of age.
2. Patients with medical conditions such as diabetes, hypertension, ischemic heart disease, tuberculosis, nephrolithiasis, peptic or duodenal ulcers, bowel diseases, and metabolic disorders.

Criteria for discontinuing or amending interventions

If any adverse event, drug susceptibility characteristics, or other illnesses occur, the patient will be withdrawn from the study. Affected patients will receive free treatment until their condition improves.

Intervention period in days

The intervention period spans 7 days.

Follow-up

Follow-up assessments will be conducted on day 8. Follow up of patient will assess about the sign and Relief of symptoms and will be assessed as per assessment criteria like Nausea, Vomiting, Diarrhoea (Bristol stool criteria), Fever, Abdominal Pain, STOOL R/M & Degree of Nausea and vomiting rating. Also, the objective criteria are of CBS, LFT, KFT can be assessed by getting the laboratory results in pretreatment and post treatment.

Primary outcomes

The study aims to establish the utility of Pippalydi Agad as an adjuvant drug therapy for managing acute food poisoning, effectively reducing symptoms such as nausea, vomiting, diarrhea, and abdominal pain.

Secondary outcomes

Given the widespread availability of Pippalydi Guggul across India, this study can contribute to a cost-effective, safe, and easily accessible solution for managing acute food poisoning. The simplicity of its preparation further bolsters its potential as an effective remedy.

Enrollment and interventions schedule

Patients will receive medication twice daily for a span of 7 days. Assessments will be conducted on days 0, 1, 3, 5, and 8.

Recruitment

Patient recruitment will adhere to a randomized standard controlled open superiority clinical trial approach, utilizing computerized tables for allocation. Patient recruited as per eligibility criteria and Participants ready to give informed written consent, Individual between Ages 18 to 50 years either sex, Participants having history and symptoms of acute food poisoning – Nausea, vomiting, diarrhoea, fever, abdominal pain. And information given to related physician and respective services provider who is treating the food poison patients.

Implementation

The drug formulated in the form of tablet and given by oral route with the Honey as adjuvant drug with standard drug and the standard drug treatment is taken from the global standard which includes Tab O2 (200 mg/500 mg) Tab Dompan (10/20 mg) Tab Cyclopam 1 tab SOS. By oral route with water twice a day.

Data collection methods

For the purpose of data collection, a randomized allocation approach will be employed to ensure an impartial distribution of participants across the two study groups. This randomization process contributes to minimizing bias and achieving a balanced representation of individuals.

Assessment criteria

The assessment of participant outcomes will encompass both subjective and objective parameters, facilitating a comprehensive evaluation of their responses to the interventions and the impact of the treatments on their health status.

Subjective parameters

1. Nausea: Participants’ self-reported feelings of nausea will be recorded and assessed as a subjective parameter. Thae nausea is one of the symptoms of food poison and can be assessed with scale¹¹ and this scale can assessed by the help of patient Table 2.
2. Vomiting: Instances of vomiting will be documented based on participants’ reports, enabling an evaluation of the intervention’s effect on this symptom.
3. Diarrhea (Bristol Stool Criteria): The Bristol Stool Chart will be utilized to categorize and analyze participants’ stool consistency, providing insights into the impact of the interventions on diarrhea.
4. Fever: Participants’ temperature measurements will be taken to monitor changes in fever and assess the effectiveness of the interventions in managing this symptom.
5. Abdominal pain: The level of abdominal pain experienced by participants will be gathered through their subjective accounts, aiding in the assessment of pain relief provided by the interventions.
6. Stool routine/Microscopy (Stool R/M): Stool samples will undergo routine and microscopic examination to identify any changes in the characteristics of participants’ stool, offering valuable insights into the interventions’ effects on gastrointestinal health.

Table 2. Nausea and vomiting intensity scale.

Sr No	Measure	Rating scale	Description
1	None	0	No Nausea
2	Anticipated	1	Nausea is anticipated but prophylaxis medication may be given
3	Mild	2	Nausea reported able to tolerate food or medication by mouth
4	Moderate	3	Nausea persisting, Lacks of appetite able to eat small meals occasionally
5	Great	4	Nausea ongoing No appetite unable to tolerate food/medication by mouth
6	Severe	5	Nausea with dry heaves reported

Objective parameters

1. Complete Blood Count (CBC): The participants’ blood samples will be analyzed through a complete blood count to determine any alterations in their blood cell composition, which could provide indications of their overall health status.
2. Liver Function Tests (LFT): Liver function tests will be conducted using participants’ blood samples to evaluate the impact of the interventions on liver health and functionality.
3. Kidney Function Tests (KFT): Kidney function tests will assess the effect of the interventions on the participants’ kidney health by analyzing their blood samples.
4. Serum Superoxide Dismutase (SOD) Level: The level of serum superoxide dismutase will be measured to gauge the participants’ oxidative stress status, reflecting the impact of the interventions on their antioxidant defense mechanisms.

Data management

Data management responsibilities will be carried out by the principal investigator, who will oversee the coding of collected data. This process ensures organized and systematic handling of the information gathered throughout the study.

Statistical methods

Various statistical methods, including the Wilcoxon signed-rank test, Mann Whitney U test, and student’s t-test, will be employed for data analysis by using SPSS version 23. Specialized software will be utilized to facilitate the application of these methods, contributing to accurate and meaningful interpretation of the study results.

Ethics and dissemination

Approval from the Institutional Ethical Committee has been obtained, with reference number MGACHRC/IEC/July-2022/542. This ethical endorsement reflects the study’s commitment to conducting research with integrity and adherence to established ethical standards.

Confidentiality

Throughout the course of the study, utmost confidentiality will be maintained for each patient’s personal and medical information. This commitment to privacy safeguards the participants’ sensitive data and upholds their rights.

Dissemination policy

The study’s findings will be disseminated through paper publications. This mode of dissemination ensures that the results are shared with the scientific community and contribute to the collective knowledge in the field.

Informed consent materials

Participants will receive comprehensive informed consent materials, including a model consent form and relevant documentation. This empowers participants with clear information about the study, enabling them to make informed decisions about their involvement.

Dissemination

This study protocol will be published in an indexed journal.

Study status

The study has yet to start.

Discussion

The term “Agada” signifies a therapeutic intervention aimed at addressing symptoms associated with illness, toxicity, and related conditions. The translation of “Agada” aligns with the concept of a remedy, referred to as “Vishaghnakalpa”.¹² Within the framework of Ayurvedic texts like the Yogaratnakara, Pippalyadi Agada emerges as a prominent entity among several Agada Kalpas. This formulation involves the utilization of Vishaghana plants, contributing to the creation of Pippalyadi Agada. As detailed by Yogaratnakara, this specific Agada holds utility in managing Dooshivisha Chikitsa,¹³ encompassing symptoms such as Kitibha, urticarial rashes, shwas, and others, which are addressed through deepan, shaman, and analogous approaches.

An essential facet of Pippalyadi Agada is its active component possessing notable anti-inflammatory and antioxidant properties. Particularly in instances of acute food poisoning characterized by clinical manifestations like nausea, vomiting, fever, and diarrhea, the inherent attributes of this formulation prove significantly beneficial. The formulation’s action extends to functioning as a carminative, effectively curbing prolonged diarrheal symptoms, while also embodying anti-toxic (Vishaghna) qualities.¹⁴

The plausible mechanism of action for Pippalyadi Agada unfolds as follows: The formulation prioritizes swift suppression of imbalanced Vata and Kapha doshas, rendering it more efficacious than interventions targeting Agni and Pittastana. This distinction culminates in the provision of enduring relief. Consequently, Pippalyadi Agada emerges as a viable Ayurvedic intervention for mitigating food poisoning. It is conveniently available in the form of Vati, with a recommended dosage of 500 mg administered twice daily. Anuapan Honey complements the administration, and the recommended course spans 7 days.

Data availability

None.

References

1. Dhanya S, Ramesh NV, Mishra A: Traditional methods of food habits and dietary preparations in Ayurveda—the Indian system of medicine. J Ethn Foods. 2019; 6: 14. Publisher Full Text
2. Patel TM: AAHAR MATRA AND AAHAR SEVAN KALA W.S.R. TO CHARAKA SAMHITA.2019; 7.
3. Agrawal AK, Yadav CR, Meena MS: Physiological aspects of Agni. Ayu. 2010; 31: 395–398. PubMed Abstract | Publisher Full Text | Free Full Text
4. Tomar S, Madhukar JP: COMPREHENSIVE ACCOUNT OF SARPAVISHA WITH SPECIAL REFERENCE TO BRIHATTRAYI. Int J Ayurveda Pharma Res. Published Online First. 15 May 2019.
5. Ancheril IJ, Bharati AK, Gr AR: Concept of cumulative toxicity (Dushi Visha) in Ayurveda.
6. Hebbar DJ: Matrashiteeya Adhyaya: Ashtanga Hrudayam Sutrasthana 8th Chapter. Easy Ayurveda.2013.
7. Food safety: Accessed: August 30, 2023. Reference Source
8. The State of Food Security and Nutrition in the World 2022. FAO; 2022. Publisher Full Text
9. Rane S: Street Vended Food in Developing World: Hazard Analyses. Indian J Microbiol. 2011; 51: 100–106. PubMed Abstract | Publisher Full Text | Free Full Text
10. Ranga V, Ranga S: Clinical Evaluation Of Ashmarihar Kasaya In The Management Of Urolitiasis (Mutrashmari). Int Res J Ayurveda Yoga. 2022; 05: 79–93. Publisher Full Text
11. Wengritzky R, Mettho T, Myles PS, et al.: Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010; 104: 158–166. PubMed Abstract | Publisher Full Text
12. Agadtantra, Vyavahar-Ayurveda Evum Vidhivaidyak (Toxicology, Forensic Medicine, and Medical Jurisprudence) Archives. Chaukhambha.
13. Jaiswal YS, Williams LL: A glimpse of Ayurveda – The forgotten history and principles of Indian traditional medicine. J Tradit Complement Med. 2016; 7: 50–53. PubMed Abstract | Publisher Full Text | Free Full Text
14. Santana FR, de Santana Souza MT , Camargo EA: Silva JA da: Anti-inflammatory and antinociceptive effects of a pectinolide-enriched fraction from Mesosphaerum pectinatum (L.) Kuntze. J Ethnopharmacol. 2023; 302: 115916. PubMed Abstract | Publisher Full Text

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Version 1

VERSION 1 PUBLISHED 23 Apr 2024

Author details Author details

¹ Department of Agadtantra, Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra, 442001, India

Vitthal Shinde
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Nilima Wadnerwar
Roles: Methodology, Project Administration, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 23 Apr 2024, 13:361

https://doi.org/10.12688/f1000research.141879.1

Copyright

© 2024 Shinde V and Wadnerwar N. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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how to cite this article

Shinde V and Wadnerwar N. Comparative evaluation of efficacy of Pippalyadi Agada as an adjuvant drug vs. standard drug therapy in the management of acute food poisoning: A Study Protocol [version 1; peer review: 3 approved with reservations]. F1000Research 2024, 13:361 (https://doi.org/10.12688/f1000research.141879.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

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Key to Reviewer Statuses VIEW HIDE

ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

Version 1

VERSION 1

PUBLISHED 23 Apr 2024

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Reviewer Report 29 Jul 2024

Sandeep V. Binorkar, Government Ayurveda College, Maharashtra, India

Approved with Reservations

https://doi.org/10.5256/f1000research.155363.r300889

Summary:

The protocol introduces a comparative evaluation of Pippalyadi Agada as an adjuvant drug versus standard therapy for acute food poisoning management. It outlines the significance of antimicrobial resistance and underreporting of foodborne illnesses, emphasizing the need ... Continue reading

Summary:

The protocol introduces a comparative evaluation of Pippalyadi Agada as an adjuvant drug versus standard therapy for acute food poisoning management. It outlines the significance of antimicrobial resistance and underreporting of foodborne illnesses, emphasizing the need for effective treatment strategies. Inclusion criteria specify participants aged 18-50 with acute food poisoning symptoms, while ethical considerations prioritize confidentiality and data management.
The methodology details a single-blind parallel design with Group A receiving standard therapy and Group B receiving Pippalyadi Agada in addition to standard therapy. Various diagnostic tests like Stool R/M, CBC, LFT, KFT, and SOD level measurements are planned to assess participants' health parameters. Data management responsibilities lie with the principal investigator, ensuring systematic handling of collected data.
The discussion contextualizes Pippalyadi Agada within Ayurvedic principles, highlighting its anti-inflammatory and antioxidant properties. The study's status is pending and awaiting commencement.

REPORT & RECOMMENDATIONS:

The study's objectives could be more precise, making it difficult to accurately assess specific outcomes or measure success. This lack of precision hampers the ability to evaluate progress and effectiveness.

The objectives should distinctly outline Primary objectives (goals), such as the main outcomes the study aims to achieve, and Secondary objectives, which encompass additional, supportive outcomes. This specificity helps clearly define the study's focus and enables a structured data collection and analysis approach.

The evaluation of Pippalyadi Agada's analytical profile needs more comprehensive detail, limiting the depth of understanding of its composition and properties. More analysis is required in order to assess its potential efficacy and safety thoroughly.

Developing a precise and standardized diagnostic protocol for acute food poisoning is imperative. This will not only improve the accuracy and consistency of diagnosis but also reassure you about the reliability of our research. The protocol will include specific criteria for symptom assessment, laboratory tests, and diagnostic procedures to ensure reliable and timely identification of foodborne illnesses.

Document the blinding process thoroughly, specifying how participants, researchers, and data analysts are unaware of treatment allocations to prevent bias. Include details on the implementation of blinding, such as labelling methods, use of placebo controls, and procedures for maintaining blinding integrity throughout the study.

The average treatment duration for acute food poisoning typically ranges from 1 to 3 days, depending on the severity of the symptoms and the causative agent. Most cases are resolved with supportive care, including hydration and rest. In this study, it's needed to justify the 7-day treatment duration for acute food poisoning.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Clinical and forensic Toxicology, Ayurveda Dermatology, Ethnomedicine, Clinical Trials

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report 23 Jul 2024

Arun Karnwal, Lovely Professional University, Phagwara, Punjab, India

Approved with Reservations

https://doi.org/10.5256/f1000research.155363.r300892

Abstract and Introduction:

1. Clarity and Coherence: The abstract should clearly outline the study's aim, methods, results, and conclusion. The current version lacks clarity and transitions between different topics without coherence.

2. Focus on ... Continue reading

Abstract and Introduction:

1. Clarity and Coherence: The abstract should clearly outline the study's aim, methods, results, and conclusion. The current version lacks clarity and transitions between different topics without coherence.

2. Focus on Antimicrobial Resistance: The introduction should provide a stronger background on antimicrobial resistance, its significance, and relevance to the study. The connection between antimicrobial resistance and the need for alternative treatments such as Ayurvedic remedies should be more explicit.

Background:

3. Antimicrobial Resistance and Foodborne Illnesses: Provide a more detailed discussion on the relationship between excessive antibiotic use, antimicrobial resistance, and the prevalence of foodborne diseases. Highlight the global burden and economic impact, with emphasis on low- to middle-income countries as outlined by the World Bank’s analysis.

4. Ayurvedic Interventions: Expand on the concept of “Agada” and its historical context. Provide more detailed information on Pippalyadi Agada, its ingredients, and their pharmacological properties. Discuss the rationale for selecting Pippalyadi Agada for this study.

Methodology:

5. Study Design: Clearly define the study design. Specify whether it is a randomized controlled trial, double-blind study, etc. Detail the criteria for participant selection, randomization process, and blinding methods if applicable.

6. Intervention Details: Provide a more detailed description of the interventions for both groups. Include specifics on the standard drug therapy used in both groups and how Pippalyadi Agada will be administered (e.g., dosage, frequency, form).

7. Outcome Measures: Clearly define the primary and secondary outcome measures. Include specifics on how symptoms such as nausea, vomiting, fever, and diarrhea will be assessed and quantified. Mention any additional parameters that will be monitored (e.g., inflammatory markers, patient-reported outcomes).

Results:

8. Data Collection and Analysis: Describe the methods for data collection and analysis. Specify statistical tests that will be used to compare outcomes between the two groups. Ensure clarity on the timeline of assessments (days 0, 3, 5, and 8).

Discussion:

9. Interpretation of Results: Discuss the potential implications of the study’s findings in the context of antimicrobial resistance and the management of foodborne illnesses. Highlight the significance of Ayurvedic interventions as complementary therapies.

10. Limitations: Address potential limitations of the study, such as sample size, participant adherence, and any biases. Discuss how these limitations will be mitigated.

Conclusion:

11. Summarize Key Findings: Provide a concise summary of the study’s key findings and their relevance. Emphasize the potential benefits of incorporating Ayurvedic remedies like Pippalyadi Agada into standard treatment protocols for acute food poisoning.

References:

12. Citations: Ensure all statements, especially those related to statistical data and claims, are backed by appropriate references. Include recent and relevant studies to support the background and discussion sections.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Food Microbiology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report 13 Jul 2024

Bharat Padhar, National Institute of Ayurveda, Jaipur, India

Approved with Reservations

https://doi.org/10.5256/f1000research.155363.r300895

Summary :
This research protocol outlines a randomized controlled trial aimed at evaluating the efficacy of Pippalyadi Agada, an Ayurvedic formulation, as an adjuvant therapy for managing acute food poisoning. The study will compare the symptom reduction and recovery ... Continue reading

Summary :
This research protocol outlines a randomized controlled trial aimed at evaluating the efficacy of Pippalyadi Agada, an Ayurvedic formulation, as an adjuvant therapy for managing acute food poisoning. The study will compare the symptom reduction and recovery time between two groups: one receiving standard drug therapy and the other receiving both standard drug therapy and Pippalyadi Agada. being conducted at MGAC & Acharya Vinoba Bhave Rural Hospital in Wardha, the trial will include 60 participants aged 18-50 with confirmed acute food poisoning. The study employs a single-blind parallel design with assessments on days 0, 3, 5, and 8, focusing on symptoms like nausea, vomiting, diarrhea, fever, and abdominal pain, as well as objective parameters such as CBC, LFT, KFT, and SOD levels. Despite the constraints of the single-blind design and the need for a more specific diagnostic protocol for food poisoning, the research aims to demonstrate the potential of Pippalyadi Agada as a cost-effective, safe, and accessible treatment option.

Review Report:

The rationale for integrating Ayurvedic principles in managing acute food poisoning is well-grounded in historical context. However, the specific objectives of the study are broad and lack precise measurability. Additionally, the methodology for evaluating the analytical profile of Pippalyadi Agada is not detailed.

The objectives should be refined to be more specific and measurable. The methodology for assessing the analytical profile of Pippalyadi Agada needs to be clearly described to ensure comprehensive understanding and replicability.

The study design is appropriate given the constraints posed by the nature of the interventions. Acknowledging the limitations of the single-blind design is important for transparency. Future studies might explore alternative methods to enhance blinding where feasible.

Recommendations for Improvement

1. Refinement of Objectives:
Current Objectives:
     1. To study the efficacy of Pippalyadi Agada as an adjuvant drug in the management of acute food poisoning.
     2. To compare the efficacy of Pippalyadi Agada as adjuvant therapy and standard drug therapy in acute food poisoning patients.
   3. To evaluate the analytical profile of Pippalyadi Agada.

Suggested Refinements:
     1. To evaluate the reduction in symptoms (nausea, vomiting, diarrhea, fever, and abdominal pain) in patients with acute food poisoning treated with Pippalyadi Agada as an adjuvant therapy.
     2. To compare the time to symptom resolution between patients receiving standard drug therapy alone and those receiving standard drug therapy with Pippalyadi Agada.
     3. To analyze the chemical composition and pharmacological properties of Pippalyadi Agada through standardized laboratory methods.

2. Include detailed procedures for the preparation, standardization, and analytical evaluation of Pippalyadi Agada. Specify the laboratory techniques (e.g., chromatography, spectroscopy) that will be used to determine its chemical composition and pharmacological properties.

3. Write a more specific and standardized diagnostic protocol for acute food poisoning to differentiate it from other conditions with similar symptoms. This could include specific biomarkers or diagnostic tests to confirm foodborne illness.

4. Describe that how participant confidentiality will be maintained throughout the study. Include details on data storage, access controls, and anonymization procedures.

5. Write the details of blinding process. Also mention that who will mask the intervention and who will be blinded i.e. participants, researcher or statistician. How the blinding breach may be handled if any. Clearly acknowledge the limitations posed by the single-blind design and discuss how these limitations will be mitigated in the study.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Ayurveda, Clinical trials, metabolic syndrome, Psychiatry and Rheumatology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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VERSION 1 PUBLISHED 23 Apr 2024

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Version 1 23 Apr 24	read	read	read

Bharat Padhar, National Institute of Ayurveda, Jaipur, India
Arun Karnwal, Lovely Professional University, Phagwara, India
Sandeep V. Binorkar, Government Ayurveda College, Maharashtra, India

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Reviewer Report

6 Views

29 Jul 2024 | for Version 1

Sandeep V. Binorkar, Government Ayurveda College, Maharashtra, India

6 Views Cite this report Responses(0)

Approved With Reservations

Summary:

The protocol introduces a comparative evaluation of Pippalyadi Agada as an adjuvant drug versus standard therapy for acute food poisoning management. It outlines the significance of antimicrobial resistance and underreporting of foodborne illnesses, emphasizing the need for effective treatment strategies. Inclusion criteria specify participants aged 18-50 with acute food poisoning symptoms, while ethical considerations prioritize confidentiality and data management.
The methodology details a single-blind parallel design with Group A receiving standard therapy and Group B receiving Pippalyadi Agada in addition to standard therapy. Various diagnostic tests like Stool R/M, CBC, LFT, KFT, and SOD level measurements are planned to assess participants' health parameters. Data management responsibilities lie with the principal investigator, ensuring systematic handling of collected data.
The discussion contextualizes Pippalyadi Agada within Ayurvedic principles, highlighting its anti-inflammatory and antioxidant properties. The study's status is pending and awaiting commencement.

REPORT & RECOMMENDATIONS:

The study's objectives could be more precise, making it difficult to accurately assess specific outcomes or measure success. This lack of precision hampers the ability to evaluate progress and effectiveness.

The objectives should distinctly outline Primary objectives (goals), such as the main outcomes the study aims to achieve, and Secondary objectives, which encompass additional, supportive outcomes. This specificity helps clearly define the study's focus and enables a structured data collection and analysis approach.

The evaluation of Pippalyadi Agada's analytical profile needs more comprehensive detail, limiting the depth of understanding of its composition and properties. More analysis is required in order to assess its potential efficacy and safety thoroughly.

Developing a precise and standardized diagnostic protocol for acute food poisoning is imperative. This will not only improve the accuracy and consistency of diagnosis but also reassure you about the reliability of our research. The protocol will include specific criteria for symptom assessment, laboratory tests, and diagnostic procedures to ensure reliable and timely identification of foodborne illnesses.

Document the blinding process thoroughly, specifying how participants, researchers, and data analysts are unaware of treatment allocations to prevent bias. Include details on the implementation of blinding, such as labelling methods, use of placebo controls, and procedures for maintaining blinding integrity throughout the study.

The average treatment duration for acute food poisoning typically ranges from 1 to 3 days, depending on the severity of the symptoms and the causative agent. Most cases are resolved with supportive care, including hydration and rest. In this study, it's needed to justify the 7-day treatment duration for acute food poisoning.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Clinical and forensic Toxicology, Ayurveda Dermatology, Ethnomedicine, Clinical Trials

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report

2 Views

23 Jul 2024 | for Version 1

Arun Karnwal, Lovely Professional University, Phagwara, Punjab, India

2 Views Cite this report Responses(0)

Approved With Reservations

Abstract and Introduction:

1. Clarity and Coherence: The abstract should clearly outline the study's aim, methods, results, and conclusion. The current version lacks clarity and transitions between different topics without coherence.

2. Focus on Antimicrobial Resistance: The introduction should provide a stronger background on antimicrobial resistance, its significance, and relevance to the study. The connection between antimicrobial resistance and the need for alternative treatments such as Ayurvedic remedies should be more explicit.

Background:

3. Antimicrobial Resistance and Foodborne Illnesses: Provide a more detailed discussion on the relationship between excessive antibiotic use, antimicrobial resistance, and the prevalence of foodborne diseases. Highlight the global burden and economic impact, with emphasis on low- to middle-income countries as outlined by the World Bank’s analysis.

4. Ayurvedic Interventions: Expand on the concept of “Agada” and its historical context. Provide more detailed information on Pippalyadi Agada, its ingredients, and their pharmacological properties. Discuss the rationale for selecting Pippalyadi Agada for this study.

Methodology:

5. Study Design: Clearly define the study design. Specify whether it is a randomized controlled trial, double-blind study, etc. Detail the criteria for participant selection, randomization process, and blinding methods if applicable.

6. Intervention Details: Provide a more detailed description of the interventions for both groups. Include specifics on the standard drug therapy used in both groups and how Pippalyadi Agada will be administered (e.g., dosage, frequency, form).

7. Outcome Measures: Clearly define the primary and secondary outcome measures. Include specifics on how symptoms such as nausea, vomiting, fever, and diarrhea will be assessed and quantified. Mention any additional parameters that will be monitored (e.g., inflammatory markers, patient-reported outcomes).

Results:

8. Data Collection and Analysis: Describe the methods for data collection and analysis. Specify statistical tests that will be used to compare outcomes between the two groups. Ensure clarity on the timeline of assessments (days 0, 3, 5, and 8).

Discussion:

9. Interpretation of Results: Discuss the potential implications of the study’s findings in the context of antimicrobial resistance and the management of foodborne illnesses. Highlight the significance of Ayurvedic interventions as complementary therapies.

10. Limitations: Address potential limitations of the study, such as sample size, participant adherence, and any biases. Discuss how these limitations will be mitigated.

Conclusion:

11. Summarize Key Findings: Provide a concise summary of the study’s key findings and their relevance. Emphasize the potential benefits of incorporating Ayurvedic remedies like Pippalyadi Agada into standard treatment protocols for acute food poisoning.

References:

12. Citations: Ensure all statements, especially those related to statistical data and claims, are backed by appropriate references. Include recent and relevant studies to support the background and discussion sections.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Food Microbiology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report

8 Views

13 Jul 2024 | for Version 1

Bharat Padhar, National Institute of Ayurveda, Jaipur, India

8 Views Cite this report Responses(0)

Approved With Reservations

Summary :
This research protocol outlines a randomized controlled trial aimed at evaluating the efficacy of Pippalyadi Agada, an Ayurvedic formulation, as an adjuvant therapy for managing acute food poisoning. The study will compare the symptom reduction and recovery time between two groups: one receiving standard drug therapy and the other receiving both standard drug therapy and Pippalyadi Agada. being conducted at MGAC & Acharya Vinoba Bhave Rural Hospital in Wardha, the trial will include 60 participants aged 18-50 with confirmed acute food poisoning. The study employs a single-blind parallel design with assessments on days 0, 3, 5, and 8, focusing on symptoms like nausea, vomiting, diarrhea, fever, and abdominal pain, as well as objective parameters such as CBC, LFT, KFT, and SOD levels. Despite the constraints of the single-blind design and the need for a more specific diagnostic protocol for food poisoning, the research aims to demonstrate the potential of Pippalyadi Agada as a cost-effective, safe, and accessible treatment option.

Review Report:

The rationale for integrating Ayurvedic principles in managing acute food poisoning is well-grounded in historical context. However, the specific objectives of the study are broad and lack precise measurability. Additionally, the methodology for evaluating the analytical profile of Pippalyadi Agada is not detailed.

The objectives should be refined to be more specific and measurable. The methodology for assessing the analytical profile of Pippalyadi Agada needs to be clearly described to ensure comprehensive understanding and replicability.

The study design is appropriate given the constraints posed by the nature of the interventions. Acknowledging the limitations of the single-blind design is important for transparency. Future studies might explore alternative methods to enhance blinding where feasible.

Recommendations for Improvement

1. Refinement of Objectives:
Current Objectives:
     1. To study the efficacy of Pippalyadi Agada as an adjuvant drug in the management of acute food poisoning.
     2. To compare the efficacy of Pippalyadi Agada as adjuvant therapy and standard drug therapy in acute food poisoning patients.
   3. To evaluate the analytical profile of Pippalyadi Agada.

Suggested Refinements:
     1. To evaluate the reduction in symptoms (nausea, vomiting, diarrhea, fever, and abdominal pain) in patients with acute food poisoning treated with Pippalyadi Agada as an adjuvant therapy.
     2. To compare the time to symptom resolution between patients receiving standard drug therapy alone and those receiving standard drug therapy with Pippalyadi Agada.
     3. To analyze the chemical composition and pharmacological properties of Pippalyadi Agada through standardized laboratory methods.

2. Include detailed procedures for the preparation, standardization, and analytical evaluation of Pippalyadi Agada. Specify the laboratory techniques (e.g., chromatography, spectroscopy) that will be used to determine its chemical composition and pharmacological properties.

3. Write a more specific and standardized diagnostic protocol for acute food poisoning to differentiate it from other conditions with similar symptoms. This could include specific biomarkers or diagnostic tests to confirm foodborne illness.

4. Describe that how participant confidentiality will be maintained throughout the study. Include details on data storage, access controls, and anonymization procedures.

5. Write the details of blinding process. Also mention that who will mask the intervention and who will be blinded i.e. participants, researcher or statistician. How the blinding breach may be handled if any. Clearly acknowledge the limitations posed by the single-blind design and discuss how these limitations will be mitigated in the study.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Ayurveda, Clinical trials, metabolic syndrome, Psychiatry and Rheumatology

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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[1] 1. Dhanya S, Ramesh NV, Mishra A: Traditional methods of food habits and dietary preparations in Ayurveda—the Indian system of medicine. J Ethn Foods. 2019; 6: 14. Publisher Full Text

[2] 2. Patel TM: AAHAR MATRA AND AAHAR SEVAN KALA W.S.R. TO CHARAKA SAMHITA.2019; 7.

[3] 3. Agrawal AK, Yadav CR, Meena MS: Physiological aspects of Agni. Ayu. 2010; 31: 395–398. PubMed Abstract | Publisher Full Text | Free Full Text

[4] 4. Tomar S, Madhukar JP: COMPREHENSIVE ACCOUNT OF SARPAVISHA WITH SPECIAL REFERENCE TO BRIHATTRAYI. Int J Ayurveda Pharma Res. Published Online First. 15 May 2019.

[5] 5. Ancheril IJ, Bharati AK, Gr AR: Concept of cumulative toxicity (Dushi Visha) in Ayurveda.

[6] 6. Hebbar DJ: Matrashiteeya Adhyaya: Ashtanga Hrudayam Sutrasthana 8th Chapter. Easy Ayurveda.2013.

[7] 7. Food safety: Accessed: August 30, 2023. Reference Source

[8] 8. The State of Food Security and Nutrition in the World 2022. FAO; 2022. Publisher Full Text

[9] 9. Rane S: Street Vended Food in Developing World: Hazard Analyses. Indian J Microbiol. 2011; 51: 100–106. PubMed Abstract | Publisher Full Text | Free Full Text

[10] 10. Ranga V, Ranga S: Clinical Evaluation Of Ashmarihar Kasaya In The Management Of Urolitiasis (Mutrashmari). Int Res J Ayurveda Yoga. 2022; 05: 79–93. Publisher Full Text

[11] 11. Wengritzky R, Mettho T, Myles PS, et al.: Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010; 104: 158–166. PubMed Abstract | Publisher Full Text

[12] 12. Agadtantra, Vyavahar-Ayurveda Evum Vidhivaidyak (Toxicology, Forensic Medicine, and Medical Jurisprudence) Archives. Chaukhambha.

[13] 13. Jaiswal YS, Williams LL: A glimpse of Ayurveda – The forgotten history and principles of Indian traditional medicine. J Tradit Complement Med. 2016; 7: 50–53. PubMed Abstract | Publisher Full Text | Free Full Text

[14] 14. Santana FR, de Santana Souza MT , Camargo EA: Silva JA da: Anti-inflammatory and antinociceptive effects of a pectinolide-enriched fraction from Mesosphaerum pectinatum (L.) Kuntze. J Ethnopharmacol. 2023; 302: 115916. PubMed Abstract | Publisher Full Text

Comparative evaluation of efficacy of Pippalyadi Agada as an adjuvant drug vs. standard drug therapy in the management of acute food poisoning: A Study Protocol

Abstract

Keywords

Introduction

Objective

Case definition

Research question

Alternative hypothesis (H1)

Null hypothesis (H0)

Methods

Trial design

Table 1. Intervention plan.

Study setting

Registration

Inclusion criteria

Exclusion criteria

Criteria for discontinuing or amending interventions

Intervention period in days

Follow-up

Primary outcomes

Secondary outcomes

Enrollment and interventions schedule

Recruitment

Implementation

Data collection methods

Assessment criteria

Subjective parameters

Table 2. Nausea and vomiting intensity scale.

Objective parameters

Data management

Statistical methods

Ethics and dissemination

Confidentiality

Dissemination policy

Informed consent materials

Dissemination

Study status

Discussion

Data availability

References

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