high blood cholesterol overweight MedDRA version: 9.1 Level: LLT Classification code 10020602 Term: Hypercholesteremia
Conditions
Interventions
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 350-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo:
Sponsors
AZIENDA ASL BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ø Males and females 35-65 years of age Ø Total serum cholesterol 200-300 mg/dl Ø BMI > 25 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ø Documented hypersensitivity to the study treatment or its excipients Ø History of ischaemic heart disease Ø History of diabetes mellitus Ø Global cardiovascular risk: >= 20% of events expected in next 10 years and/or statin treatment Ø Presence of a severe chronic disease Ø Chronic therapy with any drug Ø Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To reduce LDL and triglyceride blood levels To reduce body weight To reduce cardiovascular risk To assess safety of treatment;Main Objective: The main aim of the study is to investigate the efficacy and safety of three months? treatment with a combination of Guggulu and Triphala on the blood levels of cholesterol in subjects with both hypercholesterolemia (200-300 mg/dl) and overweight (BMI: >25 and <35), who are not suitable for therapy with statins, due to their relatively low global cardiovascular risk (< 20% of events expected in the next 10 years;Primary end point(s): The study will allow researchers to observe a decrease in blood cholesterol of at least 10% in the treatment vs the placebo group. Assuming a mean total blood cholesterol of 250 mg/dl in enrolled subjects, with a standard deviation (SD) of 25, decrease to 225 mg/dl is expected at the end of the three-month treatment. Supposing a rate of premature withdrawals of 10/60, a reduction of total blood cholesterol to 229 mg/dl (8%) contrasted with no substantial change in the control group is expected. Enrolling 60 subjects for each group will allow us to show a statistically significant difference with a 95% power, in a 2-sided test, assuming a 0.05 alpha level. The statistical analyses will be performed by comparing the mean of the total cholesterol levels at the end of the treatment between the two groups, according to the intention-to-treat principle. | — |
Countries
Italy
Outcome results
None listed