Research on the Clinical Effect of Effective Prescription in Treating Unstable Angina.
1 other identifier
interventional
240
0 countries
N/A
Brief Summary
This study evaluates the clinical efficacy of the famous prescription in the treatment of unstable angina pectoris. All of the patients will be divided into 4 arms according to their syndrome type. One of the arms will be treated by conventional western medicine, the other three will be treated by different Chinese herbal medicine prescription at the base of conventional western medicine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2017
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMay 31, 2017
May 1, 2017
2.2 years
May 28, 2017
May 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Death caused by cardiovascular disease
Six months after drug intervention
Secondary Outcomes (4)
Myocardial enzymes
At baseline and 4 weeks after drug intervention
Blood lipid
At baseline and 4 weeks after drug intervention
Treadmill exercise test
At baseline and 4 weeks after drug intervention
The incidence of myocardial infarction or heart failure
Six months after drug intervention
Study Arms (4)
conventional western medicine
OTHERPatients in this group will be treated by conventional western medicine, including anti-platelet drugss，lipid regulating drugs, coronary vasodilator, etc.
Qi deficiency and blood stasis
EXPERIMENTALPatients in this group will be treated by Shuanghe Decoction at the base of conventional western medicine.
Qi stagnation and blood stasis
EXPERIMENTALPatients in this group will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.
Phlegm and blood stasis
EXPERIMENTALPatients in this group will be treated by Gualou Xiebai Banxia Decoction \& Danshen Decoction at the base of conventional western medicine.
Interventions
Including aspirin and clopidogrel, etc.
Mainly including statins
Mainly including nitrates
Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.
Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.
Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.
Eligibility Criteria
You may qualify if:
- Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;
- Patients have at least one of these symptoms:
- The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
- Angina pectoris during rest;
- The recent occurrence of angina pectoris caused by mild physical activity in the last month.
You may not qualify if:
- Patients dignosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure \>160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jun Lilead
Related Publications (5)
Wang J, Yang X, Chu F, Chen J, He Q, Yao K, Teng F, Gao Y, Xing Y, Wu A, Xing Y. The effects of xuefu zhuyu and shengmai on the evolution of syndromes and inflammatory markers in patients with unstable angina pectoris after percutaneous coronary intervention: a randomised controlled clinical trial. Evid Based Complement Alternat Med. 2013;2013:896467. doi: 10.1155/2013/896467. Epub 2013 May 8.
PMID: 23737852BACKGROUNDWang J, Yu G. A Systems Biology Approach to Characterize Biomarkers for Blood Stasis Syndrome of Unstable Angina Patients by Integrating MicroRNA and Messenger RNA Expression Profiling. Evid Based Complement Alternat Med. 2013;2013:510208. doi: 10.1155/2013/510208. Epub 2013 May 14.
PMID: 23762142RESULTYi GZ, Qiu YQ, Xiao Y, Yuan LX. The usefulness of xuefu zhuyu tang for patients with angina pectoris: a meta-analysis and systematic review. Evid Based Complement Alternat Med. 2014;2014:521602. doi: 10.1155/2014/521602. Epub 2014 Aug 31.
PMID: 25254054RESULTQiu Y, Xu H, Shi D. Traditional chinese herbal products for coronary heart disease: an overview of cochrane reviews. Evid Based Complement Alternat Med. 2012;2012:417387. doi: 10.1155/2012/417387. Epub 2012 Mar 28.
PMID: 22536282RESULTLiu W, Xiong X, Yang X, Chu F, Liu H. The Effect of Chinese Herbal Medicine Gualouxiebaibanxia Decoction for the Treatment of Angina Pectoris: A Systematic Review. Evid Based Complement Alternat Med. 2016;2016:8565907. doi: 10.1155/2016/8565907. Epub 2016 Sep 29.
PMID: 27777598RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jun Li, MD
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
May 28, 2017
First Posted
May 31, 2017
Study Start
August 1, 2017
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
May 31, 2017
Record last verified: 2017-05