NCT00817024

Brief Summary

We conduct this clinical trial to determine the effects of Xuefu Zhuyu capsule (based on TCM "Zheng Hou" theory) in helping recovery from coronary heart disease(CHD)after PCI and find out whether this kind of effecacy is much better within patients administered with TCM syndrome-based individualized medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 1, 2012

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

January 4, 2009

Last Update Submit

May 31, 2012

Conditions

Coronary Heart Disease

Keywords

Coronary Heart DiseasePCITraditional Chinese MedicineQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.

    4 weeks

Secondary Outcomes (1)

  • Health related quality of life (Hr-QoL); Changes in serum lipid, inflammatory reaction level and endothelial function status alternations before and after the treatment.

    4 weeks

Study Arms (3)

Xuefu Zhuyu Capsules

EXPERIMENTAL
Drug: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,

Sheng Mai Capsules

ACTIVE COMPARATOR
Drug: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules

Placebo

PLACEBO COMPARATOR
Drug: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules

Interventions

Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,DRUG

3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks

Xuefu Zhuyu Capsules
Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu CapsulesDRUG

3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks

Sheng Mai Capsules
Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai CapsulesDRUG

3# Placebo of XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Clinical diagnosis of coronary heart disease (confirmed by coronary angiography)
  • Successfully received interventional therapy (PTCA or PCI)
  • belong to TCM blood-stasis syndrome
  • Must be able to swallow tablets
  • Able to give written informed consent

You may not qualify if:

  • Symptomatic congestive heart failure(New York Heart Association class III-IV)
  • Females during pregnancy or lactation
  • Serious dysfunction in important organs (liver, lung, kidney，et al)
  • Use of concomitant Chinese herbal medicine
  • Already attend other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'an Men Hospital

Beijing, 100053, China

Location

Related Publications (2)

  • Chu FY, Wang J, Yao KW, Li ZZ. Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: A Randomized controlled trial. Chin J Integr Med. 2010 Oct;16(5):399-405. doi: 10.1007/s11655-010-9999-9. Epub 2010 Jun 10.

    PMID: 20535581DERIVED

  • Chu FY, Wang J, Sun XW, Xing YW, Yao KW, Wang SH, Li ZZ. [A randomized double-blinded controlled trial of Xuefu Zhuyu Capsule on short-term quality of life in unstable anginal patients with blood-stasis syndrome after percutaneous coronary intervention]. Zhong Xi Yi Jie He Xue Bao. 2009 Aug;7(8):729-35. doi: 10.3736/jcim20090805. Chinese.

    PMID: 19671410DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Xue-Fu-Zhu-Yu decoction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jie Wang, M.D.

    China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2009

First Posted

January 6, 2009

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 1, 2012

Record last verified: 2009-01

Locations

CN(1)