The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment
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|ClinicalTrials.gov Identifier: NCT03121521|
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Medical Universtity of Lodz
Information provided by (Responsible Party):
Cezary Chojnacki, Medical Universtity of Lodz
Introduction. Statins are generally well tolerated but not devoid of side effects. Quite often it is manifested by asymptomatic increase in the level of aspartate and alanine aminotransferase. In such cases patients to administer hepatoprotective drugs, but most of them used for this purpose are ineffective. The aim of this study was assess the usefulness of melatonin in counteracting the adverse hepatic events from statins. Methods. The research program included 60 patients(aged 47-65 years, 41 women and 23 men)with hyperlipidemia taking atorvastatin or rosuvastatin in dose 20-40 mg daily. The patients were randomly allocated in two groups. Group I (n=30) was recommended to take the same statin at a standardized daily dose of 20 mg together with melatonin at a dose 2 x 5 mg, at 7:00 and 21:00. In group II (n=30) patients took statins with placebo at the same time of the day. Follow-up laboratory tests (AST, ALT, GGT, ALP, cholesterol, triglycerides) were evaluated after 2,4 and 6 mounts of treatment.
|Condition or disease||Intervention/treatment||Phase|
|Hepatopathy||Drug: Melatonin 10 mg Drug: Placebo||Phase 4|
Show detailed description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Melatonin on Elevated Liver Enzymes During Statins Treatment|
|Actual Study Start Date :||September 1, 2012|
|Actual Primary Completion Date :||September 30, 2016|
|Actual Study Completion Date :||December 15, 2016|
Melatonin 10mg/d p.o.
Drug: Melatonin 10 mg
melatonin 10mg daily p.o.
Other Name: Melatonin Lek-AM 10mg
Placebo Comparator: placebo
placebo 10mg/d p.o.
Placebo 10mg daily p.o.
Other Name: Placebo 10mg
Primary Outcome Measures :
- liver enzymes [ Time Frame: 6 months ]levels
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