Effect of nigella sativa oil extract in patients with type 2 diabetes mellitus
Phase 2
- Conditions
- Diabtes type 2.Non-insulin dependent diabetes mellitus
- Registration Number
- IRCT201307221640N13
- Lead Sponsor
- Vice Chancellor for research of Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
subjects between 18-60 years old; type 2 diabetic patients without insulin therapy; patients with history of diabetes more than one year; patients with body mass index between 18 to 35 kg/m2. Exclusion criteria: pregnant or lactating women; smokers and alcohol consumers; patients consume antioxidant supplements (vitamin E and C, caroteniodes and coQ10); patients with cardiac, hepatic, respiratory and chronic renal diseases; patients with acute or chronic inflammation
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting blood glucose. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic colorimetric.;Fasting insulin serum. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA assay.;HbA1C (Glycosilated hemoglobin). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: ELISA.;Insulin resistance. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: HOMA-IR calculation.
- Secondary Outcome Measures
Name Time Method