Effect of Ayurveda panchakarma and rasayana therapy on gut microbiome in Diabetes patients
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/03/050816
- Lead Sponsor
- All India Institute of Ayurveda, CoE TRISUTRA CSIR IGIB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients diagnosed with Diabetes Mellitus according to WHO criteria
Subjects diagnosed for Madhemha based on general diagnostic criteria according to document of Protocol for Prevention and Control of Diabetes through Ayurveda, MoA, Page no 37, 2016
Recently diagnosed (0-5 years) patients who are not on OHA (both overweight/obese and normal BMI â?? ICMR Asian criteria #)
Subjects of either gender aged more than 18 years, <60 yrs.
Willingness to consent to randomization
Emergency cases of diabetes or under immediate consideration for hospitalization and Type 1 DM or Insulin-dependent
Patient with inflammatory bowel disease Crohns disease or ulcerative colitis, chronic diarrhoea or malabsorption Hepatitis etc
Patient with a history of other complications with DM
Female patient who is pregnant, or breast feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication
Patients having known hypersensitivity to any of the proposed trial drug
Currently under any other trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Blood sugar fasting and post prandial and HbA1C <br/ ><br>Changes seen Deha bala agni bala chetas bala <br/ ><br>Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP <br/ ><br>Potential pathways and mechanism of Shilajatu along with ADR <br/ ><br>Timepoint: Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days <br/ ><br>Changes seen Deha bala agni bala chetas bala- 0, 90th days <br/ ><br>Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days <br/ ><br>Potential pathways and mechanism of Shilajatu along with ADR <br/ ><br>
- Secondary Outcome Measures
Name Time Method Changes seen in Quality of Life in DM <br/ ><br>Variations seen in LDL, HDL, TC, HDL/TG Ratio, VLDL and TG <br/ ><br>Alterations in Gut microbiome analysis <br/ ><br>Timepoint: 0,30, 60, 90th days