A Study on Postmarketing Xuezhikang Capsule for Treating Dyslipidemia

NCT02057302 | Completed Phase 4 DMC

• 1 other identifier: 2008ZX09202-007
• Study Type: interventional
• Target: 2,400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dyslipidemia

Keywords

Xuezhikang Dyslipidemia chinese medicine RCT

Outcome Measures

Primary Outcomes (1)

• Blood samples were drawn were detected,including TC,TG,LDL-C and HDL-C

  the detect the change from baseline to the 8th week

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• safety outcomes including vital signs and laboratory tests

  to detect the change from baseline to 8th week

Study Arms (2)

Group B

PLACEBO COMPARATOR

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.

Group A

EXPERIMENTAL

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

Interventions

Xuezhikang capsule DRUG

Group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years to 75 years
• Patients with Dyslipidemia should be diagnosed according to standard western medicine diagnosis criteria
• TCM syndrome of patients with dyslipidemia should be diagnosed according to standard TCM syndrome diagnosis criteria
• Patients who have taken lipid lowering drugs should stop taking for at least two weeks before taking part in this study
• Patients agree to participate in this study and signed the informed consent form

You may not qualify if:

• Pregnant (positive pregnancy test within 7 days of starting treatment), or lactating women.
• Patients with Homozygous Familial Hypercholesterolemia
• Patients with known allergy to Chinese medicine or any other drug
• Patients with acute myocardial infarction, cerebrovascular accident , severe trauma , major surgery and cancer in half a year.
• AST or ALT level increases at least twice the upper limits of normal in patients
• Patients who are taking part in other clinical trials that will influence the results of this study

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

MeSH Terms

Conditions

Dyslipidemias

Interventions

xuezhikang

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: February 7, 2014
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Last Updated: February 7, 2014

Record last verified: 2014-02