Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
NCT ID: NCT04661709
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
502 participants
INTERVENTIONAL
2021-03-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Wen Xin granule
Patients are given Wen Xin granule by mouth, one dose daily for 2 months \& Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid.
Wen Xin granule
one dose daily, two times per day.
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Atorvastatin Calcium
20 mg tablet, one tablet each night.
Isosorbide Mononitrate Tab 20 MG
one tablet， twice daily.
Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg, two times daily.
Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
glyceryl trinitrate
be taken when angina pectoris attacks.
WXG placebo
Patients are given Wen Xin granule placebo by mouth, one dose daily for 2 months \& Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid.
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Atorvastatin Calcium
20 mg tablet, one tablet each night.
Isosorbide Mononitrate Tab 20 MG
one tablet， twice daily.
Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg, two times daily.
Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
WXG placebo
one dose daily, two times per day.
Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
glyceryl trinitrate
be taken when angina pectoris attacks.
Interventions
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Wen Xin granule
one dose daily, two times per day.
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Atorvastatin Calcium
20 mg tablet, one tablet each night.
Isosorbide Mononitrate Tab 20 MG
one tablet， twice daily.
Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg, two times daily.
Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
WXG placebo
one dose daily, two times per day.
Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
glyceryl trinitrate
be taken when angina pectoris attacks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed with CAD through coronary arteriography, clinically diagnosed with UAP in low or medium risk;
* belong to Yang deficiency and blood stasis syndrome according to TCM, and give written informed consent.
* For the diagnostic criteria of UAP, the investigators will refer to 2014 AHA/ACC Guidelines for the Diagnosis and Management of Non-ST-Elevation Acute Coronary Syndromes.
* For the TCM diagnostic criteria, the investigators will refer to Guidelines for Clinical Research into New Traditional Chinese Medicine Drugs for Chest Obstruction (2002 edition).
Exclusion Criteria
* with New York Heart Association class III or IV heart failure, in acute phase of cerebral infarction;
* with uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg in the resting state)
* with uncontrolled hyperglycemia or diabetic complications, with mental and neurological abnormalities or dysgnosia;
* female patients in pregnancy or lactation;
* by participating in other clinical trials.
35 Years
75 Years
ALL
No
Sponsors
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Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine
UNKNOWN
National Natural Science Foundation of China
OTHER_GOV
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Jun Li
Director of cardiovascular department of Guang'anmen Hospital.
Principal Investigators
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Jun Li, M.D.
Role: STUDY_DIRECTOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Contacts
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References
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Niccoli G, Montone RA, Lanza GA, Crea F. Angina after percutaneous coronary intervention: The need for precision medicine. Int J Cardiol. 2017 Dec 1;248:14-19. doi: 10.1016/j.ijcard.2017.07.105. Epub 2017 Aug 12.
Ambrose JA, Dangas G. Unstable angina: current concepts of pathogenesis and treatment. Arch Intern Med. 2000 Jan 10;160(1):25-37. doi: 10.1001/archinte.160.1.25.
Smith JN, Negrelli JM, Manek MB, Hawes EM, Viera AJ. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015 Mar-Apr;28(2):283-93. doi: 10.3122/jabfm.2015.02.140189.
Jiang M, Zhang C, Zheng G, Guo H, Li L, Yang J, Lu C, Jia W, Lu A. Traditional chinese medicine zheng in the era of evidence-based medicine: a literature analysis. Evid Based Complement Alternat Med. 2012;2012:409568. doi: 10.1155/2012/409568. Epub 2012 Jun 6.
Zhang HJ, Wang ZX. Yin-yang and Zheng: Exported from Chinese medicine. Chin J Integr Med. 2014 Apr;20(4):250-5. doi: 10.1007/s11655-014-1777-z. Epub 2014 Apr 3.
Tian PP, Wu QJ, Li J, Chen HW, Wu J, Deng YW, Xie ZC, Zhao W, Tan YQ. Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial. Trials. 2021 Nov 13;22(1):798. doi: 10.1186/s13063-021-05771-y.
Other Identifiers
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Wenxin granule-20201122
Identifier Type: -
Identifier Source: org_study_id
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