The effect of Aloe Vera leaf gel dry powder on blood glucose level in type II diabetic patients, A double – blind, randomized, placebo controlled trial
Phase 3
- Conditions
- Diabetes.Non-insulin-dependent diabetes mellitus
- Registration Number
- IRCT138706161157N2
- Lead Sponsor
- Jahad Daneshgahi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
Age between 40 to 60 years, 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%, singing the written informed consent.
Exclusion criteria: insulin therapy, infectious diseases, severe kidney, liver, heart, or pulmonary disease, hypersensitivity to any drug, foot ulcer or gangrene, major depressive disorders, previous myocardial infarction, active cancer or previous cancer during the last 5 years, alcohol consumption, cigarette smoking, pregnancy, and breast feeding.
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 one and two months. Method of measurement: Glucose oxidase method.;Glycosylated hemoglobin. Timepoint: Baseline and after two months. Method of measurement: HPLC method.
- Secondary Outcome Measures
Name Time Method SGOT. Timepoint: Baseline and after two months. Method of measurement: SGOT level in fasting blood sample by DGKG enzymatic method.;SGPT. Timepoint: Baseline and after two months. Method of measurement: SGPT level in fasting blood sample by DGKG enzymatic method.;Creatinin. Timepoint: Baseline and after two months. Method of measurement: The fasting blood Creatinin level by JAPH enzymatic method.;Cholesterol. Timepoint: Baseline and after two months. Method of measurement: Fasting blood Cholesterol level by enzymatic oxidase method.;LDL. Timepoint: Baseline and after two months. Method of measurement: Fasting blood LDL level by CDC designated comparison method.;HDL. Timepoint: Baseline and after two months. Method of measurement: Fasting blood HDL level by enzymatic oxidase method.;Triglyceride. Timepoint: Baseline and after two months. Method of measurement: Fasting blood Triglyceride level by enzymatic oxidase method.