Coronary Heart DiseaseNCT00817024
Study of Herbal Formula Corresponding to Syndrome in Treating Post Percutaneous Coronary Intervention (PCI) Patients With Coronary Heart Disease (CHD)
A study of Coronary Heart Disease, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Herbal Formula in Post PCI Patients.
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.
Read the detailed description
The effectiveness of a Chinese herbal formulae is not completely based on the disease or some biomedical indexes, but much more on the TCM syndrome(Chinese name:Zheng Hou)which is generalized from patients' TCM signs and symptoms. Thus, conventional medical curative effecacy evaluation system seems not to so fit for TCM clinical studies. Although many clinical studies from Chinese literature have reported the beneficial effects of various of TCM herbal agents in improving symptoms and signs as well as antagonism of specific pathological changes in CHD patients, most of these trials are lack of well-designed methodologies and the reliability of results still remains unclear. Therefore, we designed this clinical trial, with a randomized, placebo controlled way, to evaluate the curative effects of Xuefu Zhuyu capsule(a Chinese herbal medicine)in patients with Post-PCI CHD patients and find out whether this effects will be better displayed within subjects administered with syndrome-based individualized medication.
- Conditions
- Coronary Heart Disease
- Being tested
- Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,, Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules, Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules
- Keywords
- Coronary Heart Disease, PCI, Traditional Chinese Medicine, Quality of Life
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,Drug
3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks
Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu CapsulesDrug
3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks
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
| Study group | Role | What they receive |
|---|---|---|
| Xuefu Zhuyu Capsules | Experimental | Not described Receives: Drug: Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules, |
| Sheng Mai Capsules | Active comparator | Not described Receives: Drug: Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Investigators
- Jie Wang, M.D., Principal investigator, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817024
- Sponsor's protocol ID
- NNSF90709048
- Status last verified
- Jan 2009
- First submitted
- 4 Jan 2009
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20535581Chu 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.
PubMed 19671410
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Herbal Formula in Post PCI Patients.
- ClinicalTrials.gov ID
- NCT00817024
- Acronym / sponsor ID
- NNSF90709048
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, PCI, Traditional Chinese Medicine, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The effectiveness of a Chinese herbal formulae is not completely based on the disease or some biomedical indexes, but much more on the TCM syndrome(Chinese name:Zheng Hou)which is generalized from patients' TCM signs and symptoms. Thus, conventional medical curative effecacy evaluation system seems not to so fit for TCM clinical studies. Although many clinical studies from Chinese literature have reported the beneficial effects of various of TCM herbal agents in improving symptoms and signs as well as antagonism of specific pathological changes in CHD patients, most of these trials are lack of well-designed methodologies and the reliability of results still remains unclear. Therefore, we designed this clinical trial, with a randomized, placebo controlled way, to evaluate the curative effects of Xuefu Zhuyu capsule(a Chinese herbal medicine)in patients with Post-PCI CHD patients and find out whether this effects will be better displayed within subjects administered with syndrome-based individualized medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules,3# XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks | Drug | Xuefu Zhuyu Capsules |
| Sheng Mai Capsules Plus Placebo of Xuefu Zhuyu Capsules3# SM capsules plus 3# placebo of XFZY capsules, po, Tid, for 4 weeks | Drug | Sheng Mai Capsules |
| Placebo of Xuefu Zhuyu Capsules Plus Placebo of Sheng Mai Capsules3# Placebo of XFZY capsules plus 3# placebo of SM capsules, po, Tid, for 4 weeks | Drug | Placebo |
Primary outcome
Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes.
Time frame: 4 weeks
1 secondary outcome
Health related quality of life (Hr-QoL); Changes in serum lipid, inflammatory reaction level and endothelial function status alternations before and after the treatment.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Derived from this study: PubMed 20535581Chu 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.
- Derived from this study: PubMed 19671410Chu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Wang, M.D. principal investigator
China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Coronary Heart Disease, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of anginal attacks, alternations of TCM symptoms and signs, and electrocardiographic changes. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00817024, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012; AzTrials last refreshed its copy on 6 Nov 2026.