Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
University Health Network - Cardiovascular Rehabilitation Program
Eligibility
Inclusion criteria
Inclusion criteria: Ready to give Informed consent and Disclosure. As per WHO criteria patients diagnosed with DMT2 (less than 3 years of history) and not taking OHA People having blood sugar level Fasting blood sugar (FBS) more than or equal to 126 mg/dl and less than or equal to 154 mg/dl or Random blood sugar level (RBS) more than or equal to 200 mg/dl and less than or equal to 240 mg/dl or Postprandial blood sugar (PPBS) more than or equal to 200 mg/dl and less than or equal to 240 mg/dl and - Glycosylated haemoglobin (HbA1c) more than or equal to 6.5% and less than or equal to8 %. NOTE HbA1c from 6.5 to 8 % is mandatory for inclusion, and there should be at least 1 value in accordance with the FBS, PPBS, and RBS criteria mentioned above.
Exclusion criteria
Exclusion criteria: 1. Not willing to participate in this study or adhere to study procedures. 2. Type 1 diabetes patients on insulin and diabetic complications. 3. Those with history of pancreatitis comorbid conditions chronic debilitating disorders on medications. 4. Breast feeding or pregnant women or women with plans for pregnancy. 5. Usage of glucose lowering drugs and or weight loss drugs currently or within 1 month before first dosing 6. Use of beta blocker thiazide diuretics nicotinic acid or steroids within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the percentage of glycosylated HemoglobinTimepoint: Blood glucose analysis FBS & PPBS will be carried out at days 0, 28, 56, 84, 112, 126 & day 168 Kidney function test will be done at the beginning (day 0) and end of therapy (day 84) CBC, Thyroid function and Liver function tests will be conducted at the beginning of the trial (DAY 0). HbA1C, Lipid profile, Urine R&M, 24 hours Urine Albumin and Microalbumin test will be done at the beginning (day 0) and end of therapy (day 84) and end of follow up period (day 168) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of phytochemical constituents of Nisha Amalaki Ghanavati through validated analytical methods. 2. Reduction in fasting and postprandial blood sugar levels (in mg/dl) 3. Evaluate participant recruitment rate, adherence to intervention, and retention across both study arms. 4. Identify adverse events related to the intervention. Timepoint: day 0, day 28, day 56, day 84, day 112, day 126 & day 168 | — |
Countries
India
Contacts
Public ContactRaja Ram Mahto
All India Institute of Ayurveda
Outcome results
None listed