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CTRI Number  CTRI/2019/05/019029 [Registered on: 09/05/2019] Trial Registered Prospectively
Last Modified On: 02/05/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   To study the prevalence of diabetes in an individual specific body type i.e Prakriti through genetic study 
Scientific Title of Study   Elucidation of endophenotypes in Madhumeha vis- a- vis Prakriti through Ayurgenomics approach 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vittal Huddar 
Designation  Associate professor, Dept of Kayachikitsa Room no 621, 6th floor, academic building 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  All India Institute of Ayurveda, New Delhi

New Delhi
DELHI
110076
India 
Phone  9986697942  
Fax    
Email  dr.vghuddar@aiia.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Bhavana Prasher 
Designation  Senior Principal Scientist 
Affiliation  CSIR-Institute of Genomics and Integrative Biology - IGIB 
Address  CSIR-Institute of Genomics and Integrative Biology - IGIB, Ayurgenomics, 2nd floor Mathura Road, New Delhi

New Delhi
DELHI
110007
India 
Phone  9899107338  
Fax    
Email  bhavana.p@igib.res.in  
 
Details of Contact Person
Public Query
 
Name  Mitali Mukerji 
Designation  Senior Principal Scientist, 
Affiliation  CSIR-Institute of Genomics and Integrative Biology - IGIB 
Address  CSIR-Institute of Genomics and Integrative Biology - IGIB, Ayurgenomics, 2nd floor Mathura Road, New Delhi

New Delhi
DELHI
110007
India 
Phone  9811288052  
Fax    
Email  mitali@igib.res.in  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Raod, New Delhi - 110076 and CSIR Ayurgenomics Unit TRISUTRA, CSIR- Institute of Genomics and Integrative Biology Mathura Road, Delhi, 110007 
 
Primary Sponsor  
Name  Ministry of AYUSH govt of India 
Address  GPO Complex, AYUSH BHAWAN, B Block, INA Colony, New Delhi, Delhi 110023 
Type of Sponsor  Government funding agency 
 
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 Vittal Huddar  All India Institute of Ayurveda  AIIA hospital, Hematology Lab, 1st floor, Gautampuri, Mathura road, Sarita Vihar 110076
New Delhi
DELHI 
9986697942

drvghuddar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, All India Institute of Ayurveda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Volunteer willing to include them in the study by signing in the informed consent (Annexure-3)
Either sex
Age: 30 years and above
Freshly diagnosed cases of diabetes
Pre-diabetics
Chronic cases with or without complications
Patients on Allopathic medicines
Patients on Ayurvedic / Alternative (diet, lifestyle, drug, procedure, yoga) treatment
Patients taking combination treatment
 
 
ExclusionCriteria 
Details  Volunteer unwilling to include themselves in the study by signing in the informed consent
Secondary diabetes
Age below 30 years
Hypothyroidism
Pregnancy/lactation
Major co-morbidities like (known / Clinically diagnosed) cases of Cancer, CVA, HIV/AIDS, TB, Acute infection, any other conditions which investigator feels will jeopardize the study
Immuno compromised patients
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence/frequency of different Prakriti individuals in diabetes.
Correlation between Madhumeha and Prakriti lakshanas with elucidation of specific endophenotype of the disease.
Correlation of madhumeha endophenotypes with markers of disease progression
Development of repository of Diabetes type II samples like DNA Serum & Plasma
 
3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of madhumeha endophenotypes with molecular signatures (biochemical, genomic SNP, and gut microbial) associated with Prakriti types
• Correlation of madhumeha endophenotypes with markers of t2DM disease suceptibilityand progression
 
3 years 
 
Target Sample Size   Total Sample Size="1300"
Sample Size from India="1300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   After the completion the study the findings will be published in partnership of AIIA and IGIB 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In the recent times, there has been a steady rise in prevalence of common diseases like diabetes, asthma, cardiovascular disorders, epilepsy, stroke, schizophrenia and bipolar disorder in the world. Nearly 1% of the world population suffers from these diseases and in some cases like diabetes and obesity; the numbers are considerably higher and also dangerously on the rise. With the increase in average life expectancy of humans, this has become a major concern since most of these common diseases extend throughout life and require long-term medication often associated with added complications and/or expensive interventions. 

Ayurveda, the Ancient Indian System of Medicine which forms a living tradition of health and healing even today has a basic tenet of predictive and personalized medicine. Ayurveda/ traditional knowledge based drug discovery is being considered as an attractive option especially for complex and life-style related diseases like Diabetes, Asthma and Cardiovascular diseases including cancer. 

 Identifying factors that predispose individuals to these diseases and predict their progression as well as development of personalized healthcare to minimize side-effects is the need of the hour. In the realm of modern predictive medicine, several approaches are being attempted to identify genetic variations that are responsible for susceptibility to diseases and differential response to drugs. An integration of Ayurveda and genomics is being sought to help fill the gap. This integrative approach can accelerate discovery of markers for predictive, preventive and personalized medicine. 

Briefly, in this approach it was observed that normal healthy individuals of contrasting Prakriti types i.e. Vata, Pitta and Kapha, identified on the basis of Ayurveda, exhibit striking differences at the biochemical and genome-wide gene expression level. The researchers at CSIR- IGIB published (Prasher et al, Journal of Translational medicine, September 2008, Aggarwal et al PNAS 2010) these results of gene expression and biochemical correlates of Vata Pitta and Kapha constitution types in 2008, in Journal of translational medicine. With the advent of newer technologies, the levels of enquiries into their mechanisms of actions have gone at the molecular level. This has also lead to discovery of many novel classes of molecules into pharmacology.  
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