A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

Dyslipidemia Clinical Trial

Official title:

A Multicenter, Pragmatic Randomized, Double-blind, Placebo-controlled Trial of Xuezhikang Capsule for Treating Dyslipidemia: a Postmarketing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057302
• Other study ID #: 2008ZX09202-007
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2014
• Last updated: February 6, 2014
• Start date: March 2010

Study information

• Verified date: February 2014
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18 years to 75 years

2. Patients with Dyslipidemia should be diagnosed according to standard western medicine diagnosis criteria

3. TCM syndrome of patients with dyslipidemia should be diagnosed according to standard TCM syndrome diagnosis criteria

4. Patients who have taken lipid lowering drugs should stop taking for at least two weeks before taking part in this study

5. Patients agree to participate in this study and signed the informed consent form

Exclusion Criteria:

1. Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women.

2. Patients with Homozygous Familial Hypercholesterolemia

3. Patients with known allergy to Chinese medicine or any other drug

4. Patients with acute myocardial infarction, cerebrovascular accident , severe trauma , major surgery and cancer in half a year.

5. AST or ALT level increases at least twice the upper limits of normal in patients

6. Patients who are taking part in other clinical trials that will influence the results of this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Xuezhikang capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety outcomes including vital signs and laboratory tests		to detect the change from baseline to 8th week	Yes
Primary	Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C		the detect the change from baseline to the 8th week	No
Secondary	Traditional Chinese medicine syndrome scores (TCM-SS) and single TCM symptom		to detect the change at baseline, 2nd week, 4th week, 6th week, and 8th week	No