跳至主要内容
临床试验/CTRI/2019/05/019029
CTRI/2019/05/019029招募中不适用

Elucidation of endophenotypes in Madhumeha vis- a- vis Prakriti through Ayurgenomics approach

Ministry of AYUSH govt of India1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2019年1月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,300
试验地点
1
主要终点
Prevalence/frequency of different Prakriti individuals in diabetes.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Prevalence/frequency of different Prakriti individuals in diabetes.

时间窗: 3 years

Correlation between Madhumeha and Prakriti lakshanas with elucidation of specific endophenotype of the disease.

时间窗: 3 years

Correlation of madhumeha endophenotypes with markers of disease progression

时间窗: 3 years

Development of repository of Diabetes type II samples like DNA Serum & Plasma

时间窗: 3 years

次要结局

  • 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)

研究者

发起方
Ministry of AYUSH govt of India
申办方类型
Government funding agency

研究点 (1)

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