drugset / Trial / NCT02726555

The Efficacy and Safety of Combined Therapy With Red Yeast Rice and Low-dose Statin:Comparing With Standardized Statin

NCT02726555

Phase 3 Recruiting 240 enrolled Wenzhou Medical University
RandomizedParallel-groupDouble-blindTreatment

Summary

Double-dose statin regimen achieves merely 6% of decrease in low-density lipoprotein cholesterol (LDL-C) levels, whereas the risk of side effects increased largely. The investigators' previous pilot study (NCT01686451) has suggested that red yeast rice was of similar lipid-lowering efficacy while was associated with less fatigue than statins. The purpose of this study is to evaluate the efficacy and safety of combined therapy with red yeast rice and low-dose atorvastatin in persons with mild atherosclerotic cardiovascular disease and who qualified for statin therapy according to national guidelines.

Timeline

Start
2015-11
Primary completion
2026-05
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 10 mg
Subject red yeast rice Traditional medicine (herbal / TCM) 1.2 g