A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia
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|ClinicalTrials.gov Identifier: NCT02057302|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Dyslipidemia contributes greatly to the formation and progression of atherosclerosis (AS), which plays a dominant role in leading to CHD.
Xuezhikang is a partially purified extract of fermented red yeast rice (Monascus purpureus). It is composed of 13 kinds of natural statins, unsaturated fatty acids, ergosterol,amino acids, flavonoids, alkaloid, trace element, and so forth. Xuezhikang has been recommended in a guideline for China adult dyslipidemia prevention.
This study aims to evaluate the benefit and side effect of Xuezhikang, a potential alternative drug of statins, for patients with dyslipidemia, and thus provide further evidence for clinical application.
|Condition or disease||Intervention/treatment||Phase|
|Dyslipidemia||Drug: Xuezhikang capsule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2012|
Placebo Comparator: Group B
There are 538 patients recruited in this group. Patients in this group will take 2 capsules of placebo every time, twice every day, respectively after breakfast and supper.
Experimental: Group A
There are 1614 patients recruited in this group. Patients in this group will take 2 capsules of Xuezhikang every time, twice every day, respectively after breakfast and supper.
Drug: Xuezhikang capsule
- Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C [ Time Frame: the detect the change from baseline to the 8th week ]
- Traditional Chinese medicine syndrome scores (TCM-SS) and single TCM symptom [ Time Frame: to detect the change at baseline, 2nd week, 4th week, 6th week, and 8th week ]
- safety outcomes including vital signs and laboratory tests [ Time Frame: to detect the change from baseline to 8th week ]