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CTRI Number  CTRI/2018/01/011632 [Registered on: 31/01/2018] Trial Registered Prospectively
Last Modified On: 12/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Whether Anti-diabetic drugs can be used with Ayurvedic herbs? 
Scientific Title of Study   Pharmacoepidemiological survey to observe the pattern of use Of Classical Ayurvedic herbs used along with Conventional Anti-diabetic medicines in Type II Diabetes Mellitus and Pre-clinical study for Herb-Drug Interactions of topmost unexplored plant 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Tanuja Nesari 
Designation  Head 
Affiliation  All india Institute of Ayurveda  
Address  Room No 218, Second Floor, Dept of Dravyaguna, All India Institute of Ayurveda Gautam Puri, Sarita Vihar

New Delhi
DELHI
110076
India 
Phone  9958817145  
Fax    
Email  tnesari@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Tanuja Nesari 
Designation  Head 
Affiliation  All india Institute of Ayurveda  
Address  Room No 218, Second Floor, Dept of Dravyaguna, All India Institute of Ayurveda Gautam Puri, Sarita Vihar

New Delhi
DELHI
110076
India 
Phone  9958817145  
Fax    
Email  tnesari@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geetika Pahuja 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Dept of Dravyaguna, All India Institute of Ayurveda Gautam Puri, Sarita Vihar

New Delhi
DELHI
110076
India 
Phone  8750737430  
Fax    
Email  pahujagtk@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautam Puri, Sarita Vihar, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautam Puri, Sarita Vihar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Geetika Pahuja  All India Institute of Ayurveda  Room no. 219, second floor, department of dravyaguna, All India Institute of Ayurveda,Gautam Puri, Sarita Vihar
New Delhi
DELHI 		 8750737430

Pahujagtk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Herb-Drug Interactions with Pattern of use of Classical Ayurvedic Herbs along with conventional Anti-diabetic medicines by the individuals whose blood glucose levels are elevated., (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Known Type II Diabetic patients taking Classical Ayurvedic Herbs along with Conventional Anti-Diabetic Medicines atleast from last six months 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Glycemic control based on FBS, PPBS and HbA1C  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical endpoints – Relief or aggression of Signs and symptoms
 		 12 months 
Quality of life
(The Quality of Life is proposed to be evaluated with the help of WHOQOL-SF 36 scale) 		 12 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="250" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2018 
Date of Study Completion (India) 30/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
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 world”, 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.
 
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