Evaluation of comparative efficacy of <i>Celastrus paniculatus (Jyotishmati) </i>capsule versus sertraline capsule in the management of <i>Chittodvega</i> (generalized anxiety disorder): protocol for a randomized controlled trial

Reeya Gamne; Sadhana Misar; Mayank Rai

doi:10.12688/f1000research.139473.1

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Study Protocol

Clinical trial

Evaluation of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsule versus sertraline capsule in the management of Chittodvega (generalized anxiety disorder): protocol for a randomized controlled trial

[version 1; peer review: 2 approved with reservations]

Reeya Gamne ¹, Sadhana Misar¹, Mayank Rai¹

PUBLISHED 11 Dec 2023

Author details Author details

¹ Department Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India

Reeya Gamne
Roles: Conceptualization, Investigation, Methodology, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Sadhana Misar
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Validation, Writing – Review & Editing

Mayank Rai
Roles: Conceptualization, Resources

OPEN PEER REVIEW

REVIEWER STATUS

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

Abstract

Background

Generalized anxiety disorder (GAD) (Chittodvega) is one among many types of mental disorders explained in Ayurveda. It can be defined as a Chitta (mind) + Udvega (anxiety)= Chittodvega- Anxious status of a mind. Celastrus paniculatus is one of the most important medicinal plants of the Celatraceae family commonly known as Jyotishmati. It stimulates and improves the digestive fire and metabolism at a cellular level (Jatharagni and Majja dhatwagni). It can be correlated to GAD. GAD is characterized by feelings of threat, restlessness, irritability, sleep disturbance, and tension, and symptoms such as palpitations, dry mouth, and sweating. It affects women more frequently than men and prevalence rates are high in midlife (prevalence in females over age 35: 10%) and older subjects. In modern medicine the first-line psychological and pharmaceutical treatments are selective serotonin reuptake inhibitors (SSRIs) like sertraline (SNRIs).

Aim and objectives

To evaluate the comparative efficacy of Jyotishmati versus sertraline in the management of Chittodvega.

Methods

In this randomized clinical equivalence trial a total of 70 patients will be enrolled and divided into two equal groups. Patients between 20–50 years age of either gender having symptoms of Chittodvega and a Hamilton anxiety rating (HAM-A) scale score less than 24 (i.e., mild to moderate) will be selected for the study. In Group A, sertraline capsules 25 mg for first 7 days and then dose increased to 50 mg at bedtime for next 53 days and in Group B Jyotishmati Capsules 500 mg will be given twice a day after food with water for 60 days.

Result and observation

The patients will be assessed on the HAM-A scale, serum cortisol and WHO Quality of Life on day 0, 30, 60 and 90 and data collected will be analysed by using statistical tests.

Trial registration

CTRI No. REF/2023/07/069880 Date – 15/09/2023

Keywords

Chittodvega, Celastrus paniculatus, GAD, HAM-A Scale, Jyotishmati, Medhya, Sertralin

Corresponding author: Reeya Gamne

Competing interests: No competing interests were disclosed.

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

Copyright: © 2023 Gamne R et al. 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: Gamne R, Misar S and Rai M. Evaluation of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsule versus sertraline capsule in the management of Chittodvega (generalized anxiety disorder): protocol for a randomized controlled trial [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1577 (https://doi.org/10.12688/f1000research.139473.1) First published: 11 Dec 2023, 12:1577 (https://doi.org/10.12688/f1000research.139473.1) Latest published: 28 Oct 2024, 12:1577 (https://doi.org/10.12688/f1000research.139473.3)

Introduction

Ayurveda, due to its psychosomatic approach considers the mind as an integral part of life. It advocates the integration between the mind, body and soul with holistic approach. In our bodies, there are two different types of mind qualities (Manas doshas like Satva, Rajas, and Tamas) and bodily humours like (Vata, Pitta, and Kapha). Because bodily humours and mind qualities frequently interact with one another,¹ Ayurveda accepts the idea of psychosomatic disorder. Of the three humours, Vata (Particularly Prana, Vyana, and Udana Vata) is primarily in charge of controlling and stimulating mental activity as well as generating enthusiasm. Sadhaka, a subtype of Pitta, has a direct connection to how the mind works. It is in charge of intelligence, memory, and cognition, as well as self-worth and enthusiasm.² The qualities of Kapha (Tarpaka and Bodhaka, types of Kapha) include endurance, strength, knowledge, learning, wisdom, thinking, understanding, comprehensiveness, comprehension ability, equilibrium, enthusiasm etc.³ Generalized anxiety disorder (GAD) (Chittodvega) is referred to as the “anxious status of a mind” and is described as a Chitta (mind) + Udvega (anxiety).⁴ It is referred to as Raja-tama vikara in Charaka vimana 6 (Rogaanik vimaana adhyaya).⁵

The vitiation of mind qualities like Raja and Tama leads to the development of Chittodvega. Raja is aggravated by indulgence in causative factors, which also aggravates another mind quality, i.e., Tama as well as Vata, and Pitta. In Ayurveda Chittodvega (anxiety disorders) is described as one of the causes of psychosis (Unmada) rather than as a separate disease.⁶ One of the minor psychiatric diseases is chittodvega; there is no disorientation and the patient can carry out everyday activities without much trouble (i.e neurosis),⁷ whereas psychosis (Unmada) is a major psychological disorder (impairment of orientation, i.e. psychosis), and neurosis may leads to psychosis, so can be considered as prodromal of psychosis (Unmada).⁸

The symptoms of Chittodvega are similar to those of GAD, which are muscle tension, poor concentration, autonomic arousal, feeling “on edge” or restless, and insomnia. GAD manifests as persistent, excessive, and/or exaggerated worry. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) includes the following diagnostic criteria: anxiety and worry that has lasted at least six months.⁹ Controlling the worry is difficult. For at least 6 months, the anxiety is connected with three or more of the following symptoms: 1. Restlessness, tenseness, or apprehension. 2. Being easily exhausted. 3. Difficulty concentrating or going blank, as well as impatience. 4. Muscle tenseness. 5. Sleep deprivation. Irritability: anxiety causes severe distress or impairment in social and work settings.¹⁰ There is no physiologic reason for the worry.¹¹

Many disorders are more common today, and one of them is mental illness, which stands as India’s third largest health burden according to a World Health Organization (WHO) report.¹² WHO estimates that 264 million people globally, or 3.6%, suffer from an anxiety illness. Additionally, anxiety affects 4.6% of females and 2.6% of males worldwide.¹³ The following primary categories of anxiety disorders are included in the DSM-5, according to the American Psychiatric Association: acute stress disorder, post-traumatic stress disorder, obsessive compulsive disorder (OCD), GAD, agoraphobia without panic, social phobia (social anxiety disorder), specific phobia, and anxiety disorder not otherwise mentioned.¹⁴

In modern medicine, GAD management consists of psychotherapy, like cognitive behavioral therapy (CBT) and pharmacological approaches such as cannabis, citalopram, escitalopram, sertraline, duloxetine, and venlafaxine.¹⁵ The first-line psychological and pharmaceutical treatments are CBT and selective serotonin reuptake inhibitors (SSRIs) like sertraline; alternative possibilities include selective norepinephrine reuptake inhibitors (SNRIs). Compared to other anxiolytics, SSRIs deal with depression, which is frequently co-occurring with anxiety and has less adverse effects.¹⁶ The World Federation of Societies of Biological Psychiatry recommends SSRIs, and SNRIs as first-line therapies for GAD. However the medicine should treat the condition without any adverse effects on the body. So, there is a need to search for better treatment with less complications.

One of the most significant medicinal plants in the Celatraceae family is Celastrus paniculatus, also known as Jyotishmati. It is a deciduous, woody forest climber that grows primarily in mountainous terrain. Jyotishmati is a combination of the words “enlightens” (Jyoti) and “brain functions” (mati), which means “enlightens the psychomotor function.” The seed oil (Jyotishmati taila) is well renowned for its intellect-promoting (medhya) properties. As a brain tonic, it is used to boost intelligence and improve memory.¹⁷ With its pungent and bitter taste and hot potency, Celastrus paniculatus (Jyotishmati) has an effect on three bodily humours of the body. It strengthens the ability of grasping and remembering (i.e Grahana and Smarana) and supports Sadhak Pitta (a subtype of pitta). Both digestion and cellular metabolism (Jatharagni and Majja dhatwagni) are stimulated and improved by its attributes.¹⁸ By clearing and opening the micro channel, it enhances circulation and offers appropriate nutrition.¹⁹^,²⁰

In Bhavaprakash Nighantu and Raj Nighantu it is mentioned as intellect promoting (Medhya) drug.²¹

Need for the study

One type of anxiety illness, known as generalized anxiety disorder (GAD), is marked by excessive worry and anxiety that the individual with it has trouble controlling. GAD leads to functional disability and a markedly reduced quality of life for the patient.²² This constituted 25–30% of psychiatric outpatients.²³ International Statistical Classification of Diseases and Related Health Problems ICD 10 enlists anxiety as one of the symptoms. Anxiety has a significant financial impact on the healthcare system that cannot be overlooked. Its prevalence is about 2–4%, along with psychological arousal, muscle tension, sleep problems, and restlessness.²⁴ Many people live with GAD, which makes it difficult for them to engage in relationships, employment, and other parts of life. Due to the problems of living in a materialistic, competitive society as well as the modern way of life, these types of symptoms and diseases are becoming more and more prevalent day by day.²⁵

To reduce the impact of these ongoing health hazards, treatment regimens are always being sought for the management of anxiety and the reduction of stress. Substitutes to SSRIs, benzodiazepines, and other prescribed medication are highly sought after in an effort to reduce exposure to hazardous effects related to these drugs.²⁶

The intellect promoting (Medhya) medicines described in the Ayurvedic texts have a powerful effect on the mind, have the ability to lower anxiety, and support mental wellness. It is also mentioned in the classics that the one who uses rejuvenating (medhya rasayana) drugs would attain longevity, memory, intellect, youth, luster, skin tone and voice, excellent functioning of the body and sense organs.

Presently there is a need for safer and effective drugs for GAD (Chittodvega) and less research have been done in this regard in recent years. Celastrus paniculatus is one such herb mentioned having intellect promoting (Medhya) property.²⁷

As a result, this study aims to assess the effectiveness of Celastrus paniculatus (Jyotishmati) capsules in the treatment of Chittodvega.

Aim: Evaluation of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsules versus sertraline capsules in the management of Chittodvega (generalized anxiety disorder).

Objective

Primary

• To evaluate the efficacy of Jyotishmati capsules on the Hamilton anxiety rating-scale (HAM-A) and serum cortisol level.
• To evaluate the efficacy of sertraline capsules on the HAM-A Scale and serum cortisol level.
• To compare the efficacy of both on the HAM-A Scale and serum cortisol level.

Secondary

• To evaluate the efficacy of Jyotishmati capsules on quality of life.
• To evaluate the efficacy of sertraline capsules on quality of life.
• To compare the efficacy of both on quality of life.

Methods

Ethical considerations

The study will start after clearance from the institutional ethics committee of Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod (H), Wardha. And after CTRI registration (Ref. No. REF/2023/07/069880) Date – 15/09/2023.

The committee will decide on the endpoint and oversee the trial as it progresses. The researcher will assess any adverse event and will report these to the ethics committee. The committee will decide on the endpoint and oversee the trial as it progresses.

Before conducting the trial, written informed consent will be taken from the patient in the local language while explaining every aspect of the study. The researcher will take consent from trial participants.

The personal information of the participants will be collected and kept confidential before, during, and after the trial. Physical data will be stored in a protected storage facility with only access to the researcher. Computerized data will be held in a password-protected hard drive with only access to the researcher.

Study setting

The patients will be selected from Kayachikitsa Out-patient department and In-patient department of the Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H) and peripheral camps, mainly the population of Wardha district including patients of all community, (Maharashtra) India.

A total of 70 patients will be recruited for the study. They will randomly be divided into two groups; Group A – sertraline capsules, and Group B – Jyotishmati capsules. All the baseline parameters will be recorded at the start of the study. The patients will undergo treatment for 60 days for both groups. All the parameters will be recorded at the 0^th, 30^th, 60^th, 90^th day of the study duration.

Eligibility criteria

Inclusion criteria

• Patients willing to take part in a research study and ready to give written informed consent.
• Patients will be selected according to DSM-V,²⁸ ICD-10²⁹ criteria for anxiety disorders.
• A score of less than 24 on HAM-A scale.
• Age group of 20 to 50 years of either sex.
• Free of psychiatric conditions other than anxiety.

Exclusion criteria

• Current primary diagnosis of a comorbid disorder deemed to require treatment prior to GAD, such as major depressive disorder, panic disorder, social phobia, obsessive compulsive disorder, post-traumatic stress disorder, or drug dependency.
• Currently undertaking CBT with a psychologist.
• GAD (Chittodvega) due to drug abuse, a medication or due to general medical state like hyperthyroidism.
• Alcoholic, and self-harm or suicide risk.
• Diagnosed with psychosis, schizophrenia, or bipolar illness currently or in the past.
• Treatment with sertraline for two or more weeks within the previous three months.
• Pregnant and lactating mothers.

Intervention description

• Group A – sertraline capsules 25 mg at bedtime for 1 week, then increased to 50 mg with water for 60 days.
• Group B – Jyotishmati capsules containing processed seed powder of Jyotishmati, 500 mg twice a day with water for 60 days.

Preparation

Jyotishmati (Celastrus paniculatus) seed will be pulverized into powdered form which then will be sieved and three bhavanas (trituration) of Jyotishmati phanta will be given to it according to Churnakriya method mentioned in Sharangadhara Samhita in Dattatreya Ayurved Rasashala, Salod (H), Wardha.³⁰ The processed powder will be filled into capsules.

Intervention modification

Any adverse effect during the treatment will be noted and will be informed to the ethical committee. The patients will be taken care of for the adverse effect. If participants want to drop out, this will be mentioned with the reason for discontinuing the treatment.

Outcomes

• Primary – Reduction in Hamilton A score and serum cortisol levels,
• Secondary – Improvement in quality of life.

Participant timeline

Patients will be treated for 60 days and assessment will be done up to 90 days as mentioned in Figure 1.

Figure 1. Showing study timeline.

Sample size formula using mean difference

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Z_{α} = 1.96

α = Type I error at 5% at both sides two tailed

Z_{β} = 1.28 = Power at 90%

Primary Variable = Hamilton anxiety rating scale (Anxiety Assesment)

Before the treatment (sertraline) Hamilton Anxiety Rating Scale (mean ± sd) = 19.38 ± 4.318, (As per reference article).³¹

After the treatment (sertraline) Hamilton Anxiety Rating Scale at 28 day (mean ± sd) = 15.70 ± 4.550,

Mean difference (δ) = 3.68

Pooled Std. Deviation = (4.318+ 4.550)/2 = 4.434

Sample size N = 31

Considering 10 % drop out = 3

Total sample size required = 31+3 = 34 per group.

For protocol purposes and according to the calculated sample size for each group is = 34

Recruitment

As per sample size calculation, total 34 patients will be recruited which include 31 patients and 3 drop outs. Data collected will be analyzed by using appropriate statistical methods. The patients of Chittodvega will be selected from the Kayachikitsa Out-patient department and In-patient department of Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H), and from specialized peripheral camps.

A total of 70 patients will be recruited for the study.

Enrolment and interventions time schedule

The intervention period will be from 0 to 60 days and follow up on the 0^th, 30^th, 60^th and 90^th day.

Guidelines

This protocol follows the SPIRIT guidelines.²³

Case definition

Patients between 20–50 years of age of both gender having symptoms of Chittodvega and a HAM-A scale score of less than 24, i.e., mild to moderate cases, will be selected for the study.

Type of study

Interventional study.

Study design

Randomized active controlled double blind equivalence trial.

Investigation – Serum cortisol level.

Diagnostic criteria – DSM-V Diagnostic Criteria for Generalized Anxiety Disorder.³²

Assessment criteria

1. Hamilton Anxiety Scale – HAM-A assessment will be done on 0, 30, 60 and 90 days by asking the validated questionnaire attached in annexure.³³
2. Serum cortisol level – will be assessed before and after treatment in our lab.
3. WHO Quality of life – assessment will be done on 0, 30, 60 and 90 days by asking the validated questionnaire attached in annexure.³⁴

Assignment of interventions

Allocation sequence generation – Computer-generated random numbers.

Allocation implementation – The researcher or the first author will generate an allocation sequence, enrol participants, and assign participants to intervention.

Sampling procedure

Randomization will be done by computer-generated random allocation software by SPSS 7.0 to avoid bias in the study.

Concealment of allocation

A third person will do coding to allocate subjects in sequentially numbered, opaque, sealed envelopes in groups A or B (SNOSE Scheme) to avoid bias in the study.

Blinding – Randomized active controlled double blind equivalence trial, i.e., trial participants and care providers will be blinded in the study.

Data collection plan

Data will be assessed according to HAM-A Scale, WHO Quality of life, on 0^th, 30^th, 60^th & 90^th day and serum cortisol at baseline and after completion of treatment. See Table 1.

Table 1. Plan for collection of data.

Group	Sample size	Intervention	Dose and frequency	Anupana	Duration	Follow up
A	35	Sertraline Capsule	25 mg at bed time for 1 week, then increased to 50 mg	With water	60 days	Day 0^th, 30^th, 60^th, 90^th
B	35	Jyotishmati Capsule	500 mg twice a day after food	With water	60 days	Day 0^th, 30^th, 60^th, 90^th

Drug collection/authentication

The raw material for the drug will be purchased from an authentic shop from Nagpur (Wagh brothers) and will be identified by the department of Dravyaguna and Rasashastra of M.G.A.C.H. and RC, Salod, Wardha.

Data analysis

After the study, the data will be analyzed according to a suitable statistical test.

The collected data will be entered in the software SPSS version 22. Man-Whitney and Wilcoxon tests will be used if the distribution of data was not normal. A chi squared test will be used to compare the qualitative variables. Independent t-test will be used to compare the mean of the two groups in the normal distribution of data, and for comparison before and after data, the paired t-test will be used.

Study status

Drug preparation is in process.

Discussion

Chitta (mind) + Udvega (anxiety) = Chittodvega, or anxious mental state. However, Chittodvega is a more appropriate expression for describing the entire anxious illness.³⁵ As a result, the term Chittodvega is compared to GAD in this study. GAD patients exhibit chronic, excessive, and/or unreasonable worry that is accompanied by muscle tension, reduced focus, autonomic arousal, a feeling of being on edge or restless, and insomnia for at least six months. This disease causes the patient to have unfocused worry and anxiety that is not related to recent traumatic experiences, but it may be worsened by specific circumstances.³⁶ GAD is a common mental condition in the general society as a whole with a prevalence of about 5%. Women are twice as likely as men to have this condition.³⁷ Medication such as selective serotonin reuptake or serotonin-norepinephrine reuptake inhibitors are the first-line treatments³⁸ but long-term use can have negative side effects such nausea, trouble sleeping, changes in appetite, dry mouth, headaches, and sexual dysfunction.³⁹ In contrast, Ayurveda states that mental disorders (manas rogas) is where mind promoting (Medhya) medicines are used. Jyotishmati (Celastrus paniculatus) is a thorny climbing polygamodioecious shrub that may climb up to 10 m with the help of a nearby tree. It is found virtually across India, rising to an elevation of 1800 m in the subtropical Himalayas.⁴⁰ The seed oil and fruit are often used for their tranquillizing, sedative, wound-healing, and other properties. The Ayurvedic application is primarily for its Medhya (brain tonic) activity. It can be used as a brain tonic to enhance intelligence and memory. Its Deepana (stimulating digestion) property help in improving deranged digestive fire (Agni) and thereby balancing bodily as well as mental humours (Sharir and Manas dosha)⁴¹ Jyotishmati is a renowned medicinal herb recognised for its brain-boosting properties that has been used for generations in Ayurvedic medicine to sharpen memory and improve concentration and cognitive function.⁴²

Data monitoring: formal committee.

Dissemination

This protocol will be further published as a thesis to disseminate the study for GAD (Chittodvega). The study protocol provides a detailed overview of the study design, methodology, data collection procedures, data analysis plan, and ethical considerations. By disseminating this protocol, we hope to advance knowledge in the field and facilitate future research by posters, papers and publications.

Data availability

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Evaluation of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsule versus sertraline capsule in the management Of Chittodvega (generalized anxiety disorder) – protocol for a randomized controlled trial’. https://doi.org/10.5281/zenodo.8125916.⁴³

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgments

The authors recognize the invaluable assistance provided by the scholars whose articles are mentioned and referenced in the manuscripts. The authors are also appreciative of the authors, editors, and publishers of all the papers, journals, and books that were used to review and debate the literature for this.

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40. Debnath M, Biswas M, Shukla VJ, et al.: Phytochemical and analytical evaluation of Jyotishmati (Celastrus paniculatus Willd.) leaf extracts. Ayu. 2014; 35(1): 54–57. PubMed Abstract | Publisher Full Text | Free Full Text
41. Dhumal SR, Shete RV, Adak VS, et al.: A review on Celastrus paniculatus wild (Jyotishmati): It’s species, geographical sources, phytoconstituents, and therapeutic uses and pharmacological actions. IJHM. 2021; 9(4): 112–118.
42. Bhanumathy M, Harish MS, Shivaprasad HN, et al.: Nootropic activity of Celastrus paniculatus seed. Pharm. Biol. 2010; 48(3): 324–327. Publisher Full Text
43. Dr Gamne R : Evaluation Of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsule versus Sertraline capsule in the management Of Chittodvega (Generalized Anxiety Disorder) - RCT (Version V1). Zenodo. 2023. Publisher Full Text

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Version 3

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Author details Author details

¹ Department Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India

Reeya Gamne
Roles: Conceptualization, Investigation, Methodology, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Sadhana Misar
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Validation, Writing – Review & Editing

Mayank Rai
Roles: Conceptualization, Resources

Competing interests

No competing interests were disclosed.

Grant information

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

Article Versions (3)

version 3

Revised

Published: 28 Oct 2024, 12:1577

https://doi.org/10.12688/f1000research.139473.3

version 2

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Published: 17 Jun 2024, 12:1577

https://doi.org/10.12688/f1000research.139473.2

version 1

Published: 11 Dec 2023, 12:1577

https://doi.org/10.12688/f1000research.139473.1

© 2023 Gamne R et al. 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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Gamne R, Misar S and Rai M. Evaluation of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsule versus sertraline capsule in the management of Chittodvega (generalized anxiety disorder): protocol for a randomized controlled trial [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1577 (https://doi.org/10.12688/f1000research.139473.1)

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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Reviewer Report 06 Jun 2024

Punam Khobarkar, Kayachikitsa, All India Institute of Ayurveda, New Delhi, India

Approved with Reservations

https://doi.org/10.5256/f1000research.152749.r286303

1.Title:
It is precise and informative, giving a clear indication of the research topic.
2.Abstract:
The abstract succinctly summarizes the background, objectives, methodology, and anticipated outcomes. However, it could benefit from a more detailed description of the study design, including specific statistical methods and anticipated sample size, to better inform the reader about the study's robustness and scope.
3.Introduction
The introduction provides a comprehensive overview of GAD, detailing its prevalence, symptoms, and the limitations of current pharmacological treatments, such as side effects and dependency issues. The rationale for investigating Celastrus paniculatus (Jyotishmati) is well-grounded, citing its historical use in Ayurvedic medicine and previous studies suggesting its anxiolytic properties.
4.Literature Review:
The introduction could be strengthened by including a more exhaustive review of contemporary studies and meta-analyses on the efficacy of Jyotishmati and Sertraline, thereby situating the current research within the broader scientific context.
5.Aims and Objectives
The study’s aims and objectives are clearly articulated. The primary objective is to compare the efficacy of Jyotishmati and Sertraline in reducing anxiety symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A). Secondary objectives include assessing changes in serum cortisol levels and evaluating quality of life improvements.
6.Methods
a.Study Design:
The study employs a randomized clinical equivalence trial design, which is appropriate for comparing the effectiveness of two interventions. However, further elaboration on the randomization process, blinding procedures (if any), and controls to mitigate bias would enhance the methodology's rigor.
b.Participants:
Inclusion and exclusion criteria are well-defined, ensuring a relevant study population. Yet, additional details on the demographic characteristics of the target population would be beneficial.
c.Intervention:
The interventions are described with adequate detail, specifying the dosage and duration of treatment for both Jyotishmati and Sertraline. However, the manuscript should provide more information on the standardization and quality control of the Jyotishmati capsules used.
d.Outcome Measures:
Primary and secondary outcome measures are appropriate and clearly defined. The choice of HAM-A for primary outcome and serum cortisol levels, along with quality of life assessments, as secondary outcomes are justified. Including information on the validity and reliability of these measures within the study context would be advantageous.
e.Data Collection and Analysis:
The data collection methods are thorough, but the statistical analysis section is underdeveloped. A more detailed plan, including sample size calculation, power analysis, handling of missing data, and specific statistical tests to be used, would enhance the study’s scientific rigor.
f. Ethical Considerations
The manuscript adequately addresses ethical considerations, mentioning informed consent, confidentiality, and the approval by an institutional ethics committee. This reflects adherence to ethical standards in clinical research.
7.Expected Outcomes:
While the manuscript outlines expected outcomes, it should also discuss potential challenges and limitations in greater detail, such as sample size constraints, adherence issues, and potential biases.
8.Discussion:
The discussion should provide a balanced view of the study's potential impact on clinical practice and future research. It should also elaborate on how the findings could influence the treatment paradigm for GAD, especially in contexts where traditional and alternative medicine practices intersect.
9.Strengths:
Comprehensive background and rationale for the study.
Clearly defined aims and objectives.
Detailed description of interventions and outcome measures.
Ethical considerations are well addressed.
10.Weaknesses:
The abstract could be more detailed regarding the study design and statistical methods.
The methodology section lacks comprehensive details on randomization, blinding, and statistical analysis.
The literature review in the introduction could be more exhaustive.
The discussion does not sufficiently address potential limitations and the broader impact of the study findings.
The manuscript presents a well-conceived study protocol to compare the efficacy of Jyotishmati and Sertraline in managing GAD. Addressing the noted weaknesses, particularly in the methodological and analytical details, will enhance the study's scientific validity and reliability. This research has the potential to provide significant insights into alternative treatments for GAD, contributing to the broader field of integrative medicine.

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?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: ayurveda cardiology, diabetes, insomnia, herbsl medicine, ayurveda

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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Author Response 20 Jun 2024

Reeya Gamne, Department Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, India

20 Jun 2024

Author Response

THANKS FOR THE REVIEW.
Competing Interests: No competing interests were disclosed.
THANKS FOR THE REVIEW.
THANKS FOR THE REVIEW.
Competing Interests: No competing interests were disclosed. Close
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Author Response 20 Jun 2024

Reeya Gamne, Department Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, India

20 Jun 2024

Author Response

THANKS FOR THE REVIEW.
Competing Interests: No competing interests were disclosed.
THANKS FOR THE REVIEW.
THANKS FOR THE REVIEW.
Competing Interests: No competing interests were disclosed. Close
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Reviewer Report 05 Jun 2024

Savitha H P, Kayachikitsa and manasaroga, SDM College of Ayurveda & Hospital, Hassan, Karnataka, India

Approved with Reservations

https://doi.org/10.5256/f1000research.152749.r281408

1. Evaluation of comparative efficacy of Jyotishmati ( Celastrus paniculatus ) capsule versus sertraline capsule in the management of Chittodvega (generalized anxiety disorder) - A Proposed protocol for a randomized controlled trial
2. Introduction and need for study - need to include explanation behind comparing with sertraline as control as there are many other SSRIs.
3. Introduction is very lengthy and it needs to be crisp and clear
4. Repetitions in inclusion and exclusion criteria
5. Justify about the dose of both control and study drugs
6. There is difference in the prescription of control drug in abstract and study plan which needs to be corrected
7. Inclusion of a modern psychiatrist in the study enhances the quality of proposal
7. Discussion has to be crisp

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?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Clinical research, Survey study, Literary research

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Report a concern

Author Response 20 Jun 2024

Reeya Gamne, Department Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, India

20 Jun 2024

Author Response

Thanks for the review.
Competing Interests: No competing interests were disclosed.
Thanks for the review.
Thanks for the review.
Competing Interests: No competing interests were disclosed. Close
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Author Response 20 Jun 2024

Reeya Gamne, Department Kayachikitsa, Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, India

20 Jun 2024

Author Response

Thanks for the review.
Competing Interests: No competing interests were disclosed.
Thanks for the review.
Thanks for the review.
Competing Interests: No competing interests were disclosed. Close
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Version 2 (revision) 17 Jun 24		read	read
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Savitha H P, SDM College of Ayurveda & Hospital, Hassan, India
Punam Khobarkar, All India Institute of Ayurveda, New Delhi, India
Danish Javed, All India Institute of Medical Sciences, Bhopal, India
Rachael Frost, Liverpool John Moores University, Liverpool, UK

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Reviewer Report

1 Views

16 Jan 2025 | for Version 3

Rachael Frost, Liverpool John Moores University, Liverpool, England, UK

1 Views Cite this report Responses(0)

Approved With Reservations

This manuscript outlines a trial protocol comparing Celastrus paniculatus with sertraline. The study is a valuable one and will contribute to our understanding of plant extracts for anxiety. However, the protocol needs to be more clearly reported, with greater contextual information and consider particularly the issue of blinding and the type of analysis (see detailed points below).
Abstract:

The information about GAD should come before Celastrus info.
Why is SNRI in brackets at the end of the background? Sertraline is SSRI not SNRI.
Background section should briefly summarise if previous studies have found positive or null results.
Primary outcome should be stated in results section.
A statement regarding the impact of the results should be included.

Introduction

Good explanation of how Ayurvedic concepts relate to GAD and therefore the rationale for choice of plant to test
I am not aware of cannabis commonly being used as a GAD treatment (I am in the UK and certainly it is not the case here, but I am not sure elsewhere) – CBD extract may be more commonly used over the counter if that is what the authors are referring to?

“International Statistical Classification of Diseases and Related Health Problems ICD 10 enlists anxiety as one of the symptoms.” – symptoms of what?
“less research have been done in this regard in recent years” – a review we carried out showed an increase over time in herbal anxiety research, albeit still at much smaller numbers than depression.
There is no discussion of any prior Celastrus research regarding anxiety or other mental disorders. Please include this, or a statement that there is none. It is important to contextualise the current study.
Objectives are phrased somewhat unusually – most trials simply state comparative objectives without additional within-group change objectives (which are not that useful).

Methods:

The committee will decide on the endpoint and oversee the trial as it progresses – sentence is repeated twice. Plus this seems unusual – studies should have a predefined endpoint as part of the protocol, with a committee deciding on early termination if needed.
Ethical considerations should include withdrawal.
“Peripheral camps” – not sure what the authors mean here, has something been lost in translation?
Age group inclusion criteria needs justification. Why do the authors not use a minimum scale cutoff of HAM-A baseline? There is no mention of chittodvega, are the authors not measuring/assessing this or assuming it is synonymous with GAD? Otherwise inclusion and exclusion criteria are reasonable.
Trial is described earlier as double blind, but the capsules are taken at different times (bedtime vs twice a day) – this would seem to unblind participants?
Drug collection should be grouped with preparation, and all details in herbal CONSORT checklist (Gagnier et al, 2006) should be followed as there are insufficient details at present (e.g. voucher specimen)
Authors should specify whether adverse effects will be asked about in a structured way or will rely on participants’ spontaneous reporting.
It is unclear why there are two primary outcomes, this is usually not recommended. The study is powered on HAM-A scores indicating this is the primary outcome.
Figure 1 should be clearer and red spell check underlines removed from text boxes.
The methods needs to be grouped more logically, similar information is presented in different places with lots of headings with little information underneath. This makes it hard for the reader to absorb relevant details. The assessment criteria presents the outcomes – this should be moved under outcomes to more clearly present what measures are being used. Likewise data analysis is discussed under recruitment, when there is already a separate section for analysis. Diagnostic criteria should go with inclusion criteria and Investigation is an outcome.
Recruitment section should specify 34 patients per group as it currently says in total at the start of this section.
Allocation implementation – The authors have contradictory statements on allocation implementation and concealment – one says it will be done by the same person, another by a third person. Please ensure consistency and write relevant information under the same heading in the same place.
Under sampling procedure the authors discuss generation of allocation sequence. Allocation is not sampling, this belongs under the sequence generation heading above.
Blinding – as above, if capsules are taken at different times in different groups, this leads to a high risk of unblinding. It needs to be clear whether the clinician/researcher assessing HAM-A scores at the end of the trial is blinded, as this is the largest influence on results.
Table 1 plan for collection of data does not include the measures collected at each timepoint but focuses on interventions. I suggest the authors base this on the SPIRIT example.
Analysis – tests are generally appropriate but it is unclear what chi-squared would be used for as all variables appear to be continuous. If groups are to be compared at baseline or vs dropouts it should state this. Analysis type (ITT, PPA, complete case etc) should be stated, with how missing data will be handled. Authors should also ensure that those withdrawing from the intervention (e.g. due to side effects) remain in the trial for collection of outcome data to reduce bias. Please specify if analyses will be adjusted for any factors.
Compliance is not discussed. Authors should state how compliance will be measured.
Data monitoring belongs under methods not discussion as per SPIRIT. More detail than ‘formal committee’ is required.

Discussion:

Very limited and mainly repeats the introduction. The authors should outline the strengths and limitations of the proposed trial, and expand upon the potential implications for research and practice.
Dissemination should include where the results, not just the protocol, will be disseminated.

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?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Ageing, mental health, herbal medicines, behavioural interventions

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Reviewer Report

6 Views

05 Aug 2024 | for Version 2

Danish Javed, All India Institute of Medical Sciences, Bhopal, India

6 Views Cite this report Responses(0)

Approved

Introduction: I have thoroughly reviewed the article. The review was conducted with a focus on the relevance, accuracy, and overall contribution of the content to the field of Ayurveda.
Content Analysis:

Relevance:
The article is highly relevant to the current trends and practices in Ayurveda. It addresses significant issues and presents well-researched information that aligns with contemporary medical knowledge and practices.
Accuracy:
The information presented in the article is accurate and supported by credible references. The data and facts have been cross-verified with existing literature, ensuring the reliability of the content.
Clarity and Coherence:
The article is well-written, with clear and coherent language. The flow of information is logical, making it easy for the reader to follow and understand the concepts discussed.
Contribution to the Field:
This article makes a valuable contribution to the field of Ayurveda. It provides new insights and practical approaches that can be beneficial for practitioners and researchers alike.
Methodology:
The research methodology adopted in the article is robust and appropriate for the study. The methods used are well-explained and justified, adding to the credibility of the findings.
References and Citations:
The article includes a comprehensive list of references and citations from reputable sources. This enhances the article's scholarly value and allows readers to further explore the topics discussed.

Based on my thorough review, I have found the article to be suitable for index. It meets the high standards required for scholarly work in the field of Ayurveda. The content is relevant, accurate, and contributes significantly to the existing body of knowledge. Therefore, I recommend this article for indexing without any reservations.

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?

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

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Ayurveda

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.

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10 Views

16 Jul 2024 | for Version 2

Punam Khobarkar, Kayachikitsa, All India Institute of Ayurveda, New Delhi, India

10 Views Cite this report Responses(0)

Approved

Dear Authors
You have addressed the previous suggestions effectively. The introduction is now clearer, the methodology is well-detailed, and the discussion is more comprehensive
The manuscript has been significantly improved in terms of clarity, consistency, and comprehensiveness. Therefore, I recommend the acceptance of this manuscript for indexing.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

ayurveda cardiology, diabetes, insomnia, herbsl medicine, ayurveda

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.

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19 Views

06 Jun 2024 | for Version 1

Punam Khobarkar, Kayachikitsa, All India Institute of Ayurveda, New Delhi, India

19 Views Cite this report Responses(1)

Approved With Reservations

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?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

ayurveda cardiology, diabetes, insomnia, herbsl medicine, ayurveda

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14 Views

05 Jun 2024 | for Version 1

Savitha H P, Kayachikitsa and manasaroga, SDM College of Ayurveda & Hospital, Hassan, Karnataka, India

14 Views Cite this report Responses(1)

Approved With Reservations

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?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Clinical research, Survey study, Literary research

Respond to this report

Responses (1)

Alongside their report, reviewers assign a status to the article:

Approved - the 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 approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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Evaluation of comparative efficacy of Celastrus paniculatus (Jyotishmati) capsule versus sertraline capsule in the management of Chittodvega (generalized anxiety disorder): protocol for a randomized controlled trial

Abstract

Background

Aim and objectives

Methods

Result and observation

Trial registration

Keywords

Introduction

Need for the study

Objective

Methods

Ethical considerations

Study setting

Eligibility criteria

Intervention description

Outcomes

Participant timeline

Figure 1. Showing study timeline.

Sample size formula using mean difference

Recruitment

Enrolment and interventions time schedule

Guidelines

Case definition

Type of study

Study design

Assessment criteria

Assignment of interventions

Sampling procedure

Concealment of allocation

Data collection plan

Table 1. Plan for collection of data.

Drug collection/authentication

Data analysis

Study status

Discussion

Dissemination

Data availability

Reporting guidelines

Acknowledgments

References

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