Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Tablet Nishamalaki: Dose of Nishamalaki-500mg/twice a day prior to meals with water
Route of administration - Oral Duration of therapy-12 months
Control Intervention1: Tablet Metformi
Sponsors
IRSHA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals of either sex between the age group of 35-49 years with a BMI in the range of 25-40 kg/m2 2. Individuals with family history of T2DM 3. Individuals ready to follow all procedures
Exclusion criteria
Exclusion criteria: 1. Known cases of T2DM 2. Individuals with known history of any other endocrinological disorders like Hypothyroidism, Aldosteronism etc. 3. Individuals with known history of Hypertension, Cardiac pathology, Chronic Kidney Disease, Liver pathologies etc 4. History of usage of herbal medications for past 15 days for any indication. History of usage of weight loss / weight gain medications for past one month. 5. Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalization of Fasting glucose,Insulin and HbA1c from prediabetic rangeTimepoint: Anthropometric measurement- Fasting glucose- Monthly Fasting Insulin and HbA1c-Every three month | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in biochemical parameters of Lipid metabolism,inflammatory and Oxidative stress markers,â?¢ Insulin-like growth factor-1 (IGF-1) and SIRT-1 and free fatty acids if any. Timepoint: Lipid profile-every three Months hs-CRP, IL-6 and MDA,Insulin-like growth factor-1 (IGF-1) and SIRT-1 and free fatty acids -every six Months | — |
Countries
India
Contacts
Public ContactDr Vijaya Pandit
Bharati Vidyapeeth Medical college
Outcome results
None listed