Health Condition 1: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere
Conditions
Interventions
Intervention1: ColRed: 15 gms twice a day in luke warm water or milk for 2 months.
Intervention2: ColRed: 30 gms once a day in luke warm water or milk for 2 months.
Control Intervention1: Placebo: 1
Sponsors
British Biologicals
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in other lipid levels (total cholesterol, HDL-cholesterol and triglycerides) Incidence of adverse events â?¢ Quality of life assessment of the subjects â?¢ Feedback with regard to product taste and consumption habits Timepoint: At week 2, week 4 and and week 8(study end). | — |
Countries
India
Contacts
Public ContactDr Manjunath
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed