Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease
NCT ID: NCT03478332
Last Updated: 2018-03-27
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
PHASE2
90 participants
INTERVENTIONAL
2017-06-01
2020-08-25
Brief Summary
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Detailed Description
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One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.
The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.
The secondary endpoint is:
1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
3. The maximum walking distance of 6-minute walk test;
4. Changes of Seattle Angina Questionnaire;
5. Hamilton Depression Scale/ Hamilton Anxiety Scale.
The safety evaluation criteria is:
1. Adverse event and serious adverse event;
2. Vital signs;
3. Resting 12 lead ECG;
4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group
The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease
Yangxinshi pill
0.6g/tablet
conventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
Control group
The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant
conventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
Placebos
Yangxinshi simulant
Interventions
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Yangxinshi pill
0.6g/tablet
conventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
Placebos
Yangxinshi simulant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis
* Sign the informed consent voluntarily
Exclusion Criteria
* Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（\<90/60mmHg）
* History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
* In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
* Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate \<60bpm) or atrioventricular block
* Severely allergic constitution, known or likely to be allergic to the test drug or its components
* Known bleeding tendency or hemorrhagic disease
* Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors
* Any other situations that researchers believe may affect the clinical research
40 Years
75 Years
ALL
No
Sponsors
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Affiliated Hospital of Changchun University of Chinese Medicine
OTHER
Responsible Party
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Xiaoping Meng
chief physician
Principal Investigators
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Xiaoping Meng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Changchun Traditional Medicine University Affiliated Hospital
Locations
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Changchun Traditional Medicine University Affiliated Hospital
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GFH-C04
Identifier Type: -
Identifier Source: org_study_id
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