Effect of Ayurveda panchakarma and rasayana therapy on gut microbiome in Diabetes patients
- Conditions
- Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,
- Registration Number
- CTRI/2023/03/050816
- Lead Sponsor
- All India Institute of Ayurveda, CoE TRISUTRA CSIR IGIB
- Brief Summary
Present studyis aiming to evaluate the efficacy of Virechana followed by Shilajatu rasayanain patients of Diabetes Mellitus type 2, on various parameters like Blood sugarfasting and post prandial and HbA1C, Apolipoprotein A1, Adiponectin, hs-CRP andAyurveda parameters like Deha bala, agni bala, chetas bala. Study is alsoaiming to see the gut microbiome alterations post Shodhana rasayana therapy in patients of Diabetes Mellitustype 2, which is a first ever attempt to study the same. Study also includesin-silico pathway analysis and ADR prediction of of present Rasayana drug
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 90
- 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 – 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 Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR Changes seen Deha bala agni bala chetas bala Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR Potential pathways and mechanism of Shilajatu along with ADR Changes in Blood sugar fasting and post prandial and HbA1C -0,30, 60, 90th days | Changes seen Deha bala agni bala chetas bala- 0, 90th days | Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP-0th and 90th days | Potential pathways and mechanism of Shilajatu along with ADR
- Secondary Outcome Measures
Name Time Method Changes seen in Quality of Life in DM Variations seen in LDL, HDL, TC, HDL/TG Ratio, VLDL and TG
Trial Locations
- Locations (1)
All India Institute of Ayurveda, Mathura road, Sarita Vihar, New Delhi
🇮🇳South, DELHI, India
All India Institute of Ayurveda, Mathura road, Sarita Vihar, New Delhi🇮🇳South, DELHI, IndiaDr Mythri H SPrincipal investigator9448727127drmythri.achar@gmail.com