The efficacy of Rheum ribes L stalk extract on lipid profile in hypercholesterolemic type II diabetic patients. A randomized, double-blind, placebo-controlled, clinical trial.
Phase 3
- Conditions
- Hypercholesterolemia.Disorders of lipoprotein metabolism and other lipidaemias
- Registration Number
- IRCT138706111157N1
- Lead Sponsor
- Jahad Daneshgahi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Age between 40 to 60 years, serum cholesterol above 100 mg/dl, confirmed type II diabetes at least for two years with fasting blood glucose above 150-250 mg/dl taking Metformin or Glibenclamid, HbA1c 7.5-10%, not taking any antihypercholesterolmic drug during past month, signing the written informed consent.
Exclusion criteria: Insulin therapy, infectious diseases, severe kidney, liver, heart and pulmonary diseases, hypersensitivity to any drug, foot ulcer or gangrene, major depressive disorder, previous myocardial infarction, active cancer or previous cancer during past 5 years, history of alcohol consumption or cigarette smoking, pregnancy, breast feeding.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL cholesterol. Timepoint: Baseline and after one month. Method of measurement: The fasting serum LDL cholesterol concentration determined in blood sample by calculating HDL and total cholesterol level.;Blood glucose. Timepoint: Baseline and after one month. Method of measurement: The fasting serum glucose concentration determined in blood sample by glucose oxidase method.
- Secondary Outcome Measures
Name Time Method Total cholesterol. Timepoint: Baseline and after one month. Method of measurement: The fasting serum total cholesterol level in blood sample by enzymatic oxidase method.;HDL. Timepoint: Baseline and after one month. Method of measurement: The fasting blood HDL level in blood sample by CDC designated comparison method.;Triglyceride. Timepoint: Baseline and after one month. Method of measurement: The fasting blood Triglyceride level in blood sample by enzymatic oxidase method.;SGOT. Timepoint: Baseline and after one month. Method of measurement: The fasting blood SGOT level in blood sample by DGKG enzymatic method.;SGPT. Timepoint: Baseline and after one month. Method of measurement: The fasting blood SGPT level by DGKG enzymatic method.;Creatinine. Timepoint: Baseline and after one month. Method of measurement: The fasting blood Creatinine level in blood sample by JAPH enzymatic method.