A Randomized, Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Safety, Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients With Mild to Moderate Hyperlipidemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperlipidemia
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. In between the first and second treatment period, all patients will enter a Washout Period of 4 weeks and during which time patients should not receive any of the study functional fruit drink.
Investigators
Brian Tomlinson
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •• Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
- •Mean plasma triglyceride \>= 4.5 mmol/l.
- •Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
- •Be able to give written informed consent prior to study start and comply with study requirements.
Exclusion Criteria
- •• Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).
- •Mean plasma triglyceride \< 4.5 mmol/l.
- •Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
- •Be able to give written informed consent prior to study start and comply with study requirements.
Outcomes
Primary Outcomes
To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by monitoring of liver function tests.
Time Frame: 5 months.
Alanine transaminase (ALT) levels as the main liver function test will be measured at the start and the end of the study.
To evaluate the hypolipidemic effect of Shanzha Fruit drink in patients with hyperlipidemia
Time Frame: 5 months.
The lipid profile including total cholesterol, HDL cholesterol, LDL-cholesterol and triglycerides will be measured at the start and the end of the study and changes from the baseline to the end of the treatment will be evaluated.
Secondary Outcomes
- To evaluate the safety of Shanzha Fruit drink in patients with hyperlipidemia by recording any adverse events reported by the study subjects or noted by the investigator.(5 months.)
- To evaluate the hypotensive effect of Shanzha Fruit Drink(5 months.)