Effectiveness and safety of Rosa Canina in treatment of patients with Type 2 Diabetes Mellitus
- Conditions
- Non-insulin-dependent diabetes mellituson-insulin-dependent diabetes mellitus.
- Registration Number
- IRCT2015122317994N4
- Lead Sponsor
- Persian Darou pharmed Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Patients with diagnosed Type 2 diabetes mellitus (at least 3 months and a maximum of 5 years passed from diagnosis)); Age of patients 40 to 65 years; Glycosylated hemoglobin is less than 8%; The patient is treated with Metformin; The patient sign a consent form.
Exclusion criteria:Insulin therapy; Type 1 diabetes patients; Patients who take complete dose of metformin (4 metformin 2000mg); Patients who take drugs that suppress the immune system; Pregnant, lactating women or women of childbearing potential who are not willing to use adequate contraception; Untreated thyroid disease patients; Kidney disease patients (and / or the level of liver enzymes ALT, AST greater than 3 times the normal value); Glomerular Filtration Rate (GFR) less than 60cc per min; Psychological disorders that cause any inability to cope with study protocol; Patients who take variable (not fixed) medications used to treat or reduce the symptoms of Type 2 Diabetes Mellitus.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the glycated hemoglobin at week 24 compared to baseline. Timepoint: Monthly for 6 months. Method of measurement: laboratory kit.
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose. Timepoint: Monthly for 6 months. Method of measurement: laboratory kit.;Post-prandial plasma glucose (PPG) after 2h. Timepoint: Monthly for 6 months. Method of measurement: laboratory kit.