E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
high blood cholesterol overweight |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020602 |
E.1.2 | Term | Hypercholesteremia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
To reduce LDL and triglyceride blood levels To reduce body weight To reduce cardiovascular risk To assess safety of treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |