Whether Anti-diabetic drugs can be used with Ayurvedic herbs?

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2018/01/011632
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. As per WHO, the global prevalence (age standardized) of diabetes has nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population as per the 2014 data and India had 69.2 million people living with diabetes i.e. 8.7% as per the 2015 data and among these 90% of cases comprises Type II Diabetes. WHO also projects that diabetes will be the 7th leading cause of death in 2030. As the Prevalence of Diabetes has been rising rapidly in middle and low- income countries, it is now an important public health problem, one of four priority non-communicable diseases (NCDs) targeted for action by world leaders. According to International Diabetes Federation(IDF) India is the home to the second largest number of adults living with diabetes worldwide, after china and it’s a high alert time for all the medical fraternity to find out prophylaxis and preventive measures to control and manage diabetes and its complications. In Ayurveda, Diabetes Mellitus can be co-related with Madhumeha mentioned under the umbrella of Prameha. As prevention and prophylaxis is the eternal strength of Ayurveda, there are approximately 67 herbs mentioned in Samhitas which have beneficial effects in Madhumeha~ Diabetes Mellitus. Since Diabetes is a chronic disease and Ayurveda also considers it as Asadhya Vyadhi, medicines are to be taken for longer duration, hence it has been observed that majority of people concurrently use one or the other herbs as per their conditions either by their own choice or after being advised by the physicians alone or along with other conventional antidiabetic medicines. Due to increasing resistance of conventional medicines the world is moving from the “synthetic world towards a more organic worldâ€, patients are increasingly seeking herbal remedies to manage medical conditions, complement conventional therapies, maintain their overall health and well-being. As per a study, 80% of the world’s population living in the developing world relies on herbal medicinal products as a primary source of healthcare and traditional medical practice which involves the use of herbs in those communities. As there is a well-accepted general belief by the public that herbal medicines are safe because they are natural,  but herbal medicines contain a combination of pharmacologically active plant constituents that are claimed to work synergistically to produce significant effects and may interact with other conventional medicines if taken simultaneously and their actions may alter and sometimes the herbs may possess interactions. Hence, herbs though a great boon for mankind, may become curse if used injudiciously. However, there are many questions paused regarding their dosage forms, dose, delivery regimen, time of administration, time gap between conventional and AYUSH medicines and herb to drug interactions if taken in combination with conventional Medicines.

To get a deep and clear vision about the patient’s condition, Vaagbhatta has mentioned three Pariksha: Darshana, Sparshana and Prashna Pariksha. Through these three Pariksha, a better understanding and analysis of disease and diseased person can be made and the big umbrella of Prashana Pariksha covers the Pharmaco-epidemiological study of the present Scenario. Pharmaco-epidemiology is the study of the use and the effects of drugs in large numbers of people and Ayurvedic Pharmacoepidemiology essentially makes an assessment for the field reality and the community practice of Ayurvedatherapeutics. In this modern era, collecting the Pharmacoepidemiological data is considered to be the Level I evidence as it provides the scientific data along with the experiential proof of evidence. So, this kind of Observational study is the need of hour.

Though some studies have already been taken on Herb-Drug interactions however the scientifically validated epidemiological data still awaits. But till date no clinical experience based data regarding actual database of use of Ayurvedic drugs mentioned in Diabetes Mellitus type II or their interactions i.e., synergistic effects or adverse effects is available. Hence, keeping the need of hour in mind, a Pharmacoepidemiological study is planned to provide the significant database for pattern of use of herbs which are used in combination with Oral Hypoglycemic agents along with the proof of evidence. Therefore, an effort will be made to review the pharmacoepidemiological profile of the unexplored Classical Ayurvedic Herbs interaction with Oral Hypoglycemic agents when given in combination for management of Diabetes Mellitus Type II in Pre-clinical studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-15
• Study Completion: 2018-11-30
• Last Update Posted: 2022-12-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Known Type II Diabetic patients taking Classical Ayurvedic Herbs along with Conventional Anti-Diabetic Medicines atleast from last six months.

Exclusion Criteria

• 1. Type I Diabetic patients.
• 2. Type II Diabetic patients who are on Insulin.
• 3. Diabetic patients suffering with associated diseases like Asthma, Cardiac disorders etc.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic control based on FBS, PPBS and HbA1C	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	(The Quality of Life is proposed to be evaluated with the help of WHOQOL-SF 36 scale)
Clinical endpoints – Relief or aggression of Signs and symptoms

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 Delhi, DELHI, India

All India Institute of Ayurveda

🇮🇳Delhi, DELHI, India

Dr Geetika Pahuja

Principal investigator

8750737430

Pahujagtk@gmail.com