Effect of Gamma-oryzanol in patients with high cholesterol levels
- Conditions
- Health Condition 1: E780- Pure hypercholesterolemia
- Registration Number
- CTRI/2020/06/026008
- Lead Sponsor
- AP Organics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
i.Age between 25 and 60 years
ii.Either gender & Attending diabetic clinical at hospital.
iii.Fasting serum LDL-Cholesterol > 130 mg/dl.
i.History of intake of dietary supplements or drugs (Retinoids, Cyclosporine, Phenothiazines) which can increase Plasma lipid level.
ii.Evidence of renal disease (S. Creatinine > 1.5mg/ml)
iii.Evidence of liver disease (AST/ALT >3 times of normal)
iv.Pregnant and lactating mothers and women intending pregnancy
v.History of alcohol intake and smoking.
vi.Participation in any other clinical trial with in the last 30 days
vii.History of intolerance or hypersensitivity Gamma-oryzanol.
viii.Any condition which in the opinion of the PI that is significant and can make the patient unsuitable for study or can place it under additional risk, such as intolerance, allergy to Gamma-oryzanol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute changes in the fasting serum LDL-C level between the gamma-oryzanol and placebo groups from baseline to 12 weeksTimepoint: i. Baseline (0 week) <br/ ><br>ii. 12 weeks
- Secondary Outcome Measures
Name Time Method <br/ ><br>Changes in the Body Mass Index (BMI) at baseline and 12 weeksTimepoint: i. Baseline (0 week) <br/ ><br>ii. 12 weeks;Changes in Total Fat Content from baseline to 12 weeks in both the groups.Timepoint: i. Baseline (0 week) <br/ ><br>ii. 12 weeks;Mean percent changes in the Total Cholesterol, Triglycerides, VLDL-C, HDL-C levels and in the LDL/HDL ratio from baseline to 12 weeks in both the groups.Timepoint: i. Baseline (0-week) <br/ ><br>ii. 12 week;To assess the adverse drug reactions in both groupsTimepoint: Throughout the study