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Utkatar, pre-diabetic, Echinops echinatus, Utkatar root ghana
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Tadke MS, Gupta R, Bokhad S et al. Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients – a study protocol [version 1; peer review: 1 approved]. F1000Research 2023, 12:1503 (https://doi.org/10.12688/f1000research.140099.1)
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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Study Protocol
Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients – a study protocol
[version 1; peer review: 1 approved]
PUBLISHED 27 Nov 2023
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Datta Meghe Institute of Higher Education and Research collection.
Abstract
Corresponding author:
Minal S. Tadke
Competing interests:
No competing interests were disclosed.
Grant information:
The author(s) declared that no grants were involved in supporting this work.
Copyright:
© 2023 Tadke MS 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: Tadke MS, Gupta R, Bokhad S et al. Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients – a study protocol [version 1; peer review: 1 approved]. F1000Research 2023, 12:1503 (https://doi.org/10.12688/f1000research.140099.1)
First published: 27 Nov 2023, 12:1503 (https://doi.org/10.12688/f1000research.140099.1)
Latest published: 27 Nov 2023, 12:1503 (https://doi.org/10.12688/f1000research.140099.1)
Introduction
A chronic disease, diabetes mellitus (DM) is distinguished by high blood sugar levels brought on by a lack of insulin (Type I DM) and relative insulin deficiency with or without insulin resistance (Type II DM).1 Diabetes prevalence varies greatly between urban and rural populations, with rural areas having a 2.5% prevalence and urban areas having a 14.6% prevalence.1 According to the Ministry of Health, 74.2 million people in India’s 20- to 79-year-old age group are anticipated to have diabetes as of December 2021. Sedentary lifestyles are the main contributor to the rise in diabetic patients around the world, which is anticipated to reach 366 million in the older population (those over 65).2
It is linked to a severe dysregulation of lipid, protein, and glucose metabolism that gradually gives rise to life-threatening consequences.3 Chronic hyperglycaemia is a characteristic shared by all the diverse disorders grouped under diabetes mellitus.4 Advanced glycation end products (AGEs) are circulating at higher levels as a result of long-term hyperglycaemia, which increases the risk of stroke and myocardial infarction as well as vascular problems that can result in diabetic retinopathy, neuropathy, and nephropathy.5 Maintaining a stable blood glucose level is essential for delaying vascular problems and preventing the formation of AGEs.6 The existing anti-diabetic medicine has a substantial number of side effects, thus there is still a need to look for medicinal herbs with useful anti-hyperglycaemic properties.6 In Ayurveda, diabetes mellitus can be co-related with Prameha and has been successfully treated from ancient time.7,8
In Gujarat, diabetes is treated by using the Echinops echinatus root bark suspension with milk.9 In Kerala, however, the whole plant is infused with a decoction to cure diabetes, along with leaf paste and leaf powder.10
Need for the study
Echinops echinatus Roxb. (Utkatar) is a traditionally used, classically described extra-pharmacopeial drug in Ayurveda. But less scientifically (clinically) explored medicinal herb. Few pre-clinical studies done on this plant revealed its anti-diabetic action but no clinical trial is found till date. So, there is an urgent need to bridge the gap between the pre-clinical studies and empirical knowledge. Hence the present research work is undertaken with the aim of exploring the anti-diabetic potential of Echinops echinatus Roxb (Utkatar) in Type II pre-diabetic patients.
Aim: The aim of this study is to compare and evaluate the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients.
Methods
Ethical considerations
The study will be started after the clearance from the I.E.C. of Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H), Wardha (I.E.C. REF No.: MGACHRC/IEC/July-2022/544 which was done on 11/08/2022) and after CTRI registration (CTRI/2023/11/059445).
The endpoint and oversee of trial will be done by the committee.
The researcher will assess any adverse event and will be reported to the committee.
The written informed consent will be taken from the patient before starting the study.
During the study, the confidentiality of each patient will be maintained.
Trial design
It will be a single-blind parallel randomized control experiment. Study intervention will be done using a 1:1 ratio on two groups.
Study setting
Patients will be recruited from the Kayachikitsa and Panchakarma Out-patient Department (OPD) and In-patient Department (IPD) of Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Wardha and from peripheral medical camps.
A total of 60 patients will be selected for the study. Randomization will be done and the patients will be divided into two groups; for group A- Echinops echinatus Roxb (Utkatar) root ghana and group B- Nishaamalaki will be given. All the baseline parameters will be recorded at the start of the study. The patients will undergo treatment for 30 days and follow-up will be done on days 0, 1, 15, 30, and 45.
Guidelines
The SPIRIT guidelines were considered for the study protocol,16 while the CONSORT guidelines will be considered for the study.
Case definition
Patients with pre-diabetes who have fasting blood sugar levels greater than 126 mg/dL and post-meal blood sugar levels greater than 200 mg/dL will be chosen for the trial.
Sampling procedure
Simple randomization will be done.
The researcher will generate the allocation sequence, enrol the participants, and assign participants to the intervention.
Study design flow chart
The study will be conducted as shown in Figure 1.
Figure 1. CONSORT chart.
OPD - Out-patient Department, IPD - In-patient Department, N - Number of patients.
Intervention description
Mature roots of E. echinatus will be collected from the campus of Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod (H), Wardha. It will be washed to remove foreign matter and shade dried. Then, it will be cut into pieces and made into a coarse powder (bharad) with the help of a grinder at Dattatray Ayurved Rasashala of Mahatma Gandhi Ayurvedic College Hospital and Research Centre, Salod(H), Wardha (GMP certificate Ayurved pharmacy Licence No.NG/AYU/002/14). For decoction, 1:16 proportion of drug and water i.e., 1 part of Utkatara powder and 16 parts of water will be taken and boiled reduce it to 1/8th.11 The decoction (quath) will be taken in a vessel and heating process will be carried out on the gas stove with continuously stirring it unless it will get converted into semisolid form. Thus, ghana will be prepared from decoction (quath) and proceed for characterization12,13 as shown in Figure 2.
Figure 2. Flow chart of preparation of drug.
Intervention modification
Patients will be removed from the study if they experience any events, drug susceptibility characteristics, or other illnesses or conditions. The patients will receive free treatment until their condition improves.
Outcome
To assess and compare the efficacy of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic condition.
Gantt chart
It consists of the following steps as shown in Table 1.
Table 1. Progression of study.
Recruitment
The study will be conducted in Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha and from specialized peripheral camps. A total of 60 patients will be recruited for the study.
Allocation sequence generation
A simple random sampling technique using a computerized table method will be used for the study.
The principal investigator will register an allocation sequence, enrol the participants and assign the intervention.
Blinding
It is a single blind superiority clinical trial i.e., a clinical trial in which the experimenters are aware of which subjects are receiving the treatment or independent variable, but the participants of the study are not.
Data collection plan
Intervention will be given as mentioned in Table 2.
Table 2. Table showing intervention given to the patients of group A and group B including its doses, anupana (vehicle) and time duration.
Drug collection and authentication
Mature roots of Echinops echinatus Roxb (Utkatar) will be collected from the field in appropriate season as per WHO Good Collection Practices (GCP) guidelines14 and classical Ayurvedic text (Charak Samhita).15 The plant sample will be collected from its natural habitat and will be authenticated by sending a specimen voucher to the Foundation for Revitalization of Local Health Traditions (FRLHT), Bangalore pharmacognosy lab.
Discussion
Since Echinops echinatus Roxb (Utkatar) is a folklore medicinal plant, The aim of this research is to provide simple, safe, and affordable methods for managing diabetes. The study also seeks to develop effective remedies for the condition. If the results of this research are positive, it will set a benchmark for future studies and establish the best treatment method for diabetes mellitus.
Authors contribution statement
Minal S. Tadke and Rajkumar Gupta did the conceptualization and study design. Minal S. Tadke will do this clinical trial. The discussion and data analysis were done by Swapna Bokhad, Swanand Joshi, and Dattatray Sarvade. For the final manuscript, the methodology and results were discussed by all the authors.
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CITE
how to cite this article
Tadke MS, Gupta R, Bokhad S et al. Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients – a study protocol [version 1; peer review: 1 approved]. F1000Research 2023, 12:1503 (https://doi.org/10.12688/f1000research.140099.1)
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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Version 1
VERSION 1
PUBLISHED 27 Nov 2023
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How to cite this report:
Pradnya C. Reviewer Report For: Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients – a study protocol [version 1; peer review: 1 approved]. F1000Research 2023, 12:1503 (https://doi.org/10.5256/f1000research.153428.r226193)
The direct URL for this report is:
https://f1000research.com/articles/12-1503/v1#referee-response-226193
https://f1000research.com/articles/12-1503/v1#referee-response-226193
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 14 Feb 2024
Chaugule Pradnya,
Dravyaguna, D Y Patil University School of Ayurveda, Navi Mumbai, Maharashtra, India
Approved
VIEWS 6
In the Gantt chart, table 1 Progression of Study, it has been mentioned about Thesis Writing. Kindly give clarification if this study is a part of P.G./Ph.D. Thesis work?
The researcher mentions collection of the drug Echinops echinatus Roxb (Utkatar) from ... Continue reading
The researcher mentions collection of the drug Echinops echinatus Roxb (Utkatar) from ... Continue reading
CITE
HOW TO CITE THIS REPORT
Pradnya C. Reviewer Report For: Comparative evaluation of the anti-diabetic activity of Echinops echinatus Roxb (Utkatar) root ghana versus Nishaamalaki in pre-diabetic patients – a study protocol [version 1; peer review: 1 approved]. F1000Research 2023, 12:1503 (https://doi.org/10.5256/f1000research.153428.r226193)
The direct URL for this report is:
https://f1000research.com/articles/12-1503/v1#referee-response-226193
https://f1000research.com/articles/12-1503/v1#referee-response-226193
NOTE: 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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