Percutaneous Coronary Artery InterventionNCT00965471
Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease
A study testing cipher prescription 1 and cipher prescription 2 in people with Percutaneous Coronary Artery Intervention and Coronary Artery Bypass Graft, run by Guangzhou University of Chinese Medicine.
Trial summary
The purpose of this study is to built the standard of Chinese Traditional Medicine test for Post percutaneous coronary artery intervention and coronary artery bypass graft，also for acute coronary syndrome，according to the multi-site、random large sample test. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Percutaneous Coronary Artery Intervention, Coronary Artery Bypass Graft, Acute Coronary Syndrome
- What is being tested?
- cipher prescription 1 and cipher prescription 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 940 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jun 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age40～75
- angina or CAD patient
- deficiency of heart-QI and blockage of phlegm and blood stasis in chinese medicine
- 1 week after operation，or 1week after drainage tube extraction for CABG
- sign a informed consent
Who cannot join
- severe cardia failure
- severe renal inadequacy
- complicating with malignant tumor,reactive alimentary tract hemorrhage and haematological systemic disorder etc.
- psychotic
- pregnant,lactation
About this study
The purpose of this study is to built the standard of Chinese Traditional Medicine test for Post percutaneous coronary artery intervention and coronary artery bypass graft，also for acute coronary syndrome，according to the multi-site、random large sample test.
- Conditions
- Percutaneous Coronary Artery Intervention, Coronary Artery Bypass Graft, Acute Coronary Syndrome
- Being tested
- cipher prescription 1, cipher prescription 2
- Keywords
- percutaneous coronary artery intervention, coronary artery bypass graft, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cipher prescription 1Drug
Drug granules include ginseng,RADIX NOTOGINSENG,prepared RHIZOMA PINELLIAE with alumen radix glyrrhigae calcaren once daily for 180 days
cipher prescription 2Drug
Placebo include amidon、bitter principles and diluents bases once daily for 180 days
| Study group | Role | What they receive |
|---|---|---|
| managed group | Experimental | Not described Receives: Drug: cipher prescription 1 |
| control group | Placebo comparator | Not described Receives: Drug: cipher prescription 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
dead
Measured: 180±3days
Secondary outcomes (1)
cardiovascular event
Measured: 180±3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startOct 2006
- Primary completionOct 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary Artery InterventionStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Guangdong Provincial People's Hospital, China-Japan Friendship Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Teaching Hospital of Nanjin University of Traditional Chinese Medicine, Second People's Hospital, Fujian Province, Liaoning University of Traditional Chinese Medicine, Guangzhou Overseas Chinese Hospital, Beijing Tongren Hospital, Shanghai 10th People's Hospital, PLA.The Military General Hospital of Beijing, The Sixth Affliated Hospital of Jinan University, Beijing Anzhen Hospital, Gansu Provincial Hospital, Shaanxi Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, The Fifth Affliated Hospital of Guangxi Medical University
- Investigators
- Ruan Xinmin, Study chair, Guangzhou University of Chinese Medecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965471
- Sponsor's protocol ID
- 2006BAI04A01
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin Y, Wang YF, Lin DQ, Chen JW, Li JZ, Lan TH, Ou AH, Ruan XM. Efficacy and safety of Huxin formula in patients after CABG: a multicenter, double-blind, randomized clinical trial. Forsch Komplementmed. 2014;21(6):351-9. doi: 10.1159/000370010. Epub 2014 Dec 11.
PubMed 25592946
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chinese Traditional Medicine for Post Revascularization Treatment of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00965471
- Acronym / sponsor ID
- 2006BAI04A01
- Conditions
- Percutaneous Coronary Artery Intervention, Coronary Artery Bypass Graft, Acute Coronary Syndrome
- Keywords
- percutaneous coronary artery intervention, coronary artery bypass graft, acute coronary syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 940 participants (estimated)
- Lead sponsor
- Guangzhou University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Sciences, Guangdong Provincial People's Hospital, China-Japan Friendship Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Teaching Hospital of Nanjin University of Traditional Chinese Medicine, Second People's Hospital, Fujian Province, Liaoning University of Traditional Chinese Medicine, Guangzhou Overseas Chinese Hospital, Beijing Tongren Hospital, Shanghai 10th People's Hospital, PLA.The Military General Hospital of Beijing, The Sixth Affliated Hospital of Jinan University, Beijing Anzhen Hospital, Gansu Provincial Hospital, Shaanxi Provincial People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, The Fifth Affliated Hospital of Guangxi Medical University
- Study start
- Oct 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Aug 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.
The purpose of this study is to built the standard of Chinese Traditional Medicine test for Post percutaneous coronary artery intervention and coronary artery bypass graft，also for acute coronary syndrome，according to the multi-site、random large sample test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| managed group | Experimental | Drug: cipher prescription 1 |
| control group | Placebo comparator | Drug: cipher prescription 2 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age40～75
- angina or CAD patient
- deficiency of heart-QI and blockage of phlegm and blood stasis in chinese medicine
- 1 week after operation，or 1week after drainage tube extraction for CABG
- sign a informed consent
Key exclusion criteria (5 listed)
- severe cardia failure
- severe renal inadequacy
- complicating with malignant tumor,reactive alimentary tract hemorrhage and haematological systemic disorder etc.
- psychotic
- pregnant,lactation
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 |
|---|---|---|
| cipher prescription 1Drug granules include ginseng,RADIX NOTOGINSENG,prepared RHIZOMA PINELLIAE with alumen radix glyrrhigae calcaren once daily for 180 days | Drug | managed group |
| cipher prescription 2Placebo include amidon、bitter principles and diluents bases once daily for 180 days | Drug | control group |
Primary outcome
dead
Time frame: 180±3days
1 secondary outcome
cardiovascular event
Time frame: 180±3days
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 25 Aug 2009.
- Derived from this study: PubMed 25592946Lin Y, Wang YF, Lin DQ, Chen JW, Li JZ, Lan TH, Ou AH, Ruan XM. Efficacy and safety of Huxin formula in patients after CABG: a multicenter, double-blind, randomized clinical trial. Forsch Komplementmed. 2014;21(6):351-9. doi: 10.1159/000370010. Epub 2014 Dec 11.
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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.
Ruan Xinmin study chair
Guangzhou University of Chinese Medecine
Questions about this trial
What is this clinical trial studying?
A study testing cipher prescription 1 and cipher prescription 2 in people with Percutaneous Coronary Artery Intervention and Coronary Artery Bypass Graft, run by Guangzhou University of Chinese Medicine.
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 5 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 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
dead (time frame: 180±3days). 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 NCT00965471, which also lists 1 linked publication.
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 25 Aug 2009.