Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
All India Institute of Ayurveda, CoE TRISUTRA CSIR IGIB
CoE TRISUTRA CSIR IGIB
Eligibility
Inclusion criteria
Inclusion criteria: 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, Willingness to consent to randomization
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Blood sugar fasting and post prandial and HbA1C Changes seen Deha bala agni bala chetas bala Alterations seen in biomarkers such as, Apolipoprotein A1, Adiponectin, hs-CRP Potential pathways and mechanism of Shilajatu along with ADR Timepoint: 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
| Measure | Time frame |
|---|---|
| Changes seen in Quality of Life in DM Variations seen in LDL, HDL, TC, HDL/TG Ratio, VLDL and TG Alterations in Gut microbiome analysis Timepoint: 0,30, 60, 90th days | — |
Countries
India
Contacts
Public ContactDr Mythri H S
All India Institute of Ayurveda
Outcome results
None listed