At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 39 enrolled
Drug / intervention
Coleosoma +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Clinical Trial for Assessing Tolerability and Effectiveness of Formula Coleosoma 29 in Patients With Dyslipidemia
In Brief
A Phase 2 clinical trial evaluating Coleosoma and Placebo for Dyslipidemias. Completed, enrolled 39 participants across 1 site.
Detailed Summary
The overall objective of the study is to assess the efficacy of Coleosoma formulation (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemias
CountriesItaly
CollaboratorsDOC generici srl
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
Primary CompletionAug 2016
Study CompletionOct 2016
First PostedJan 2017
TodayJul 2026
First PostedJan 23, 2017
Enrollment StartJan 1, 2016
Primary CompletionAug 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.4 years ago
Interventions
Coleosomadietary
patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.
Placebodietary
patients will take one tablet daily for 12 weeks.