Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
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
1 other identifier
interventional
502
0 countries
N/A
Brief Summary
This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2021
Typical duration for phase_4
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
First Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJanuary 25, 2021
January 1, 2021
2 years
November 23, 2020
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiovascular events
Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death.
Record the incidence of major adverse cardiovascular events in one year by follow-up.
Secondary Outcomes (3)
The thrombelastograph
Before treatment and at eight weeks after treatment.
TCM symptom scale score
Before treatment, four and eight weeks after treatment.
Seattle angina questionnaire
Before treatment, four and eight weeks after treatment.
Study Arms (2)
Wen Xin granule
EXPERIMENTALPatients 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.
WXG placebo
PLACEBO COMPARATORPatients 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.
Interventions
one tablet daily. (for patients who can't use aspirin)
20 mg tablet, one tablet three times daily.
Eligibility Criteria
You may qualify if:
- aged between 35 and 75 years of age;
- 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).
You may not qualify if:
- chest pain caused by congenital heart diseases, valvular heart disease, severe neurosis, or arrhythmia
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
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.
PMID: 28807510BACKGROUNDAmbrose 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.
PMID: 10632302BACKGROUNDSmith 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.
PMID: 25748771BACKGROUNDJiang 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.
PMID: 22719784RESULTZhang 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.
PMID: 26972437RESULTTian 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.
PMID: 34774099DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jun Li, M.D.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- It's a double-blind trial and includes two levels of blinding.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of cardiovascular department of Guang'anmen Hospital.
Study Record Dates
First Submitted
November 23, 2020
First Posted
December 10, 2020
Study Start
March 1, 2021
Primary Completion
March 1, 2023
Study Completion
June 1, 2023
Last Updated
January 25, 2021
Record last verified: 2021-01