Effect of Yangxinshi Tablet on Exercise Tolerance in Patients With Chronic Coronary Syndrome（MET STUDY）
NCT ID: NCT05978089
Last Updated: 2023-12-18
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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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2023-11-08
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group
Yangxinshi tablets
Yangxinshi tablet
The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
Control group
Yangxinshi tablet simulants
Yangxinshi tablet simulants
The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.
Interventions
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Yangxinshi tablet
The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
Yangxinshi tablet simulants
The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Meet the diagnostic criteria for CCS in Western medicine; stable coronary heart disease (CHD) with a degree of coronary stenosis ≥50% by angiography or computed tomography angiography (CTA) (including patients with more than 1 year of revascularization)
2. Meet the TCM standard of Qi deficiency and blood stasis syndrome
3. MET \< 5 measured by cardiopulmonary exercise test (treadmill)
4. Age between 18 and 75 years (including both age limits), with no limitation on sex
5. Understanding and voluntarily signing the written informed consent
Exclusion Criteria
1. Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests
2. Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG)
3. Individuals with serious primary diseases related to the liver, kidney, and hematopoietic system, acute infectious diseases, and mental illness and individuals with other diseases who are not suitable for cardiopulmonary exercise tests
4. Individuals with a revascularization plan within a month
5. Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG
6. Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details)
7. Individuals with New York Heart Association (NYHA) cardiac function class III and IV
8. Individuals with acute cerebrovascular disease
9. Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg
10. Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9
11. Individuals with allergies or abnormal drug reactions to the test drugs
12. Women of childbearing age who are pregnant or breastfeeding, plan to get pregnant within six months, have a positive pregnancy test, and cannot take effective contraceptive measures during the study period
13. Individuals who have regularly taken YTs, Chinese herbal decoctions or proprietary Chinese medicines with similar curative effects within the past 7 days (please refer to Appendix 12 for the names of proprietary Chinese medicines)
14. Individuals who have participated in other clinical trials within the past 3 months
15. Individuals unsuitable for the clinical trials, as determined by the researchers
18 Years
75 Years
ALL
No
Sponsors
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Dongzhimen Hospital, Beijing
OTHER
Responsible Party
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Wang Xian
Professor
Principal Investigators
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Wang Xian
Role: PRINCIPAL_INVESTIGATOR
Dongzhimen Hospital, Beijing
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Li Xianlun, Professor
Role: primary
Wang Xian, Professor
Role: primary
Luo Suxin, Professor
Role: primary
Chen Qiuxiong, Professor
Role: primary
Liu Gang, Professor
Role: primary
Wang Yongxia, Professor
Role: primary
Other Identifiers
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Growful2201YXS
Identifier Type: -
Identifier Source: org_study_id