A clinical trial to assess the safety and efficacy of Col-Red compared with Placebo on reducing cholesterol in hypercholesterolemia patients
- Conditions
- Health Condition 1: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere
- Registration Number
- CTRI/2012/06/002718
- Lead Sponsor
- British Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
A total of 30 Subjects aged between 18-65 years with known but untreated moderate hypercholesterolemia.
Subjects diagnosed with total cholesterol equal to or above 200 mg/dl and who have LDL-cholesterol levels equal to or above 130 mg/dl
Subjects who give their consent to participate after being informed of the study objectives
Severe disease necessitating pharmacological intervention
Hepatic disease, gastrointestinal complaints and ulcers, thyroid dysfunction or any kidney disease;
Personal history of cardiovascular illness.
Uncontrolled diabetes and uncontrolled hypertension in terms of the WHO criteria (140/90 mmHg)
Known food allergy.
Significant chronic organic or psychiatric disease
Not obtaining informed consent
Pregnant or lactating subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-CholesterolTimepoint: At week 2, week 4 and and week 8(study end).
- Secondary Outcome Measures
Name Time Method Change in other lipid levels (total cholesterol, HDL-cholesterol and triglycerides) <br/ ><br>Incidence of adverse events <br/ ><br>â?¢Quality of life assessment of the subjects <br/ ><br>â?¢Feedback with regard to product taste and consumption habits <br/ ><br>Timepoint: At week 2, week 4 and and week 8(study end).