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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
Intervention / Comparator Agent
|
|
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. |