Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to18 and less than or equal to 65 years 2. Not pre-treated with any ant diabetic agents within 2 months 3. Fasting Plasma Glucose Level between126 and 150 mg per dl 4. 2h plasma glucose between 200 mg per dl and 250 mg per dl 5. Random plasma glucose between 200 mg per dl and 250 mg per dl 6. HbA1c greater than or equal to 6.5percent 7. Body weight greater than 50 kg 8. Willingness to abstain from alcohol, tobacco, and any caffeine containing drinks during treatment periods 9. Ability to understand sign informed consent and comply with study protocol
Exclusion criteria
Exclusion criteria: 1. Pregnant and breastfeeding women, 2. Patients with Fasting Plasma Glucose level greater than or equal to 150mg per dl. 3. Patients with Post Prandial Plasma Glucose level greater than or equal to 150mg per dl 4. Significant pulmonary gastrointestinal cardiovascular hepatic-renal dysfunction. Diabetes Mellitus Type I or Diabetes Insipidus or Patient on Insulin Therapy HIV HCV HBSAG Cancer cardiovascular diseases autoimmune disorders 5. Evidence or a history of diabetes complications for example diabetic retinopathy neuropathy acute hyperglycaemic emergency and diabetic foot) 6. Any Seasonal illness lasting more than 10 days 7. Tobacco greater than or equal to 10 cigarettes per day within 3 months prior to screening or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fasting Blood Sugar Change in Postprandial Blood Sugar PPBS Change in HbA1c levels. Timepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight and BMI Lipid profile Total cholesterol LDL HDL Triglycerides. Liver and kidney function tests to assess safety Patient reported outcomes like fatigue thirst polyuria etc Timepoint: 90 days | — |
Countries
India
Contacts
Regional Research Institute of Unani Medicine Naseem Bagh