This study adopted a randomized, double-blind, placebo-controlled, multicenter clinical design and compared the effects of Yangxinshi tablet and placebo on exercise tolerance in patients with chronic coronary syndrome (CCS).
The aim of the research is to find out if the addition of Yangxinshi tablets on the basis of conventional treatment can improve exercise tolerance of patients with chronic coronary syndrome (CCS), improve quality of life and mental health. A total of 120 qualified CCS patients were randomly divided into two groups. In addition to conventional treatment, the experimental group was given Yangxinshi tablets (3 tablets/time and 3 times/day), and the control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day). The treatment period was 24 weeks. The primary endpoints were metabolic equivalents (METs), and peak oxygen uptake measured by cardiopulmonary exercise testing after 24 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
The treatment group was given Yangxinshi tablets (3 tablets/time and 3 times/day). The treatment period was 24 weeks.
The control group was given Yangxinshi tablet simulants (3 tablets/time and 3 times/day).The treatment period was 24 weeks.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGDongzhimen Hospital Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Cardiopulmonary exercise test (treadmill): (MET and peak oxygen uptake)
MET=Metabolic Equivalent of Task
Time frame: 24 weeks
anaerobic threshold
Cardiopulmonary exercise test (treadmill)
Time frame: 24 weeks
oxygen pulse
Cardiopulmonary exercise test (treadmill)
Time frame: 24 weeks
maximal exercise ventilation
Cardiopulmonary exercise test (treadmill)
Time frame: 24 weeks
electrocardiogram (ECG)
Start time and duration determined by 1-mm downward shift in the ST segment on the electrocardiogram (ECG) during the cardiopulmonary exercise test
Time frame: 24 weeks
CCS angina classification
The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
Time frame: 24 weeks
Seattle Angina Questionnaire
The Seattle Angina Questionaire (SAQ) quantifies patients'physical limitations caused by angina. The scale is transformed to a score of 0 to 100, where higher scores indicate better function (less physical limitation)
Time frame: 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
score range: 0\~21,higher scores mean a worse outcome.
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Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, China
RECRUITINGTime frame: 24 weeks
General Anxiety Disorder-7 (GAD-7)
score range: 0\~21,higher scores mean a worse outcome.
Time frame: 24 weeks
Patient Health Questionnaire (PHQ-9)
score range: 0-27,higher scores mean a worse outcome.
Time frame: 24 weeks
Traditional Chinese medicine (TCM) Syndrome Score
the main symptoms score range: 2-6,the secondary symptoms score range: 1-3,higher scores mean a worse outcome.
Time frame: 24 weeks
Hospitalization within 6 months of taking the medicine
total hospitalization time and hospitalization frequency
Time frame: 24 weeks