Health Condition 1: E780- Pure hypercholesterolemia
Conditions
Interventions
Intervention1: Capsule Gamma-Oryzanol 150 mg: Capsule Gamma-Oryzanol (150 mg) twice daily orally + Standard treatment for 12 weeks
Control Intervention1: Placebo capsule: Matched Placebo twice daily o
Sponsors
AP Organics
Eligibility
Inclusion criteria
Inclusion criteria: i.Age between 25 and 60 years ii.Either gender & Attending diabetic clinical at hospital. iii.Fasting serum LDL-Cholesterol > 130 mg/dl.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) ii. 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the Body Mass Index (BMI) at baseline and 12 weeksTimepoint: i. Baseline (0 week) ii. 12 weeks;Changes in Total Fat Content from baseline to 12 weeks in both the groups.Timepoint: i. Baseline (0 week) 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) ii. 12 week;To assess the adverse drug reactions in both groupsTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDebasish Hota
AIIMS BHUBANESWAR
Outcome results
None listed