EUCTR2008-008376-14-ITActive, not recruitingNot Applicable
A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO INVESTIGATE EFFICACY AND SAFETY OF COMBINED TREATMENT OF GUGGULU AND TRIPHALA FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND OVERWEIGHT IN SUBJECTS NOT SUITABLE FOR THERAPY WITH STATINS - TRIGU PROJECT
AZIENDA ASL BRESCIA0 sitesStarted: March 27, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Ø Males and females 35-65 years of age Ø Total serum cholesterol 200-300 mg/dl Ø BMI > 25 and < 35 Ø Global cardiovascular risk: < 20% of events expected in next 10 years Ø Willingness to participate in and comply with the study Ø Willingness to give informed consent Ø Willingness to prevent conception during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
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