The purpose of this study is to confirm the efficacy and safety of total flavonoids of propolis dropping pill to treat angina pectoris, evaluated by total exercise time of treadmill exercise test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
478
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
Guangdong Second Provincial Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, China
Ruikang Hospital of Guangxi Traditional Chinese Medical University
Nanning, Guangxi, China
Improvement of total exercise time of treadmill exercise test
Time frame: -2 week, 0 weeks, 12 weeks
The marked effective rate of angina pectoris
* Class I: No symptom or almost no symptom, decrease of angina pectoris total score ≥ 1/3; * Class II: No symptom or almost no symptom, decrease of angina pectoris total score ≥ 2/3; * Class III: Almost no symptom, decrease of angina pectoris total score ≥ 2/3, or the score decrease to the degree of Slight or Class I.
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Attack times of angina pectoris
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Pain degree of angina pectoris
Time frame: -2 weeks, 0 week, 12 weeks
Duration of angina pectoris attack
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Dose change of nitroglycerin
* Withdraw: completely withdrawal after the treatment; * Decrease: decrement ≥50% after the treatment; * No change: decrement \<50% after the treatment.
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
The main symptoms of Chinese Traditional Medicine
Effect index = (total score before treatment - total score after treatment)/total score before treatment×100% * Cured: effect index ≥90%; * Marked effective: 90%\> effect index ≥70%; * Effective: 70%\> effect index ≥30%; * Ineffective: effect index \<30%.
Time frame: -2 weeks, 0 week, 6 weeks, 12 weeks
Score change of the Seattle Angina Questionnaire (SAQ)
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Hubei Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China
Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
Hohhot, Neimenggu, China
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
...and 3 more locations
Time frame: 0 week, 12 weeks
Improvement of ECG
* Cured: normal or almost normal; * Marked effective: ST-segment deviation upturn≥0.05mV, but still abnormal, improvement of T-wave inversion of main leads ≥25%, or flate T-wave change to vertical, improved atrioventricular block or intraventricular block; * Effective: almost no charge; * Ineffective: anabatic ST-segment deviation, deeper T-wave, or flate T-wave change to inverted.
Time frame: -2 weeks, 0 week, 12 weeks
Improvement of other indexes of treadmill exercise test
metabolic equivalent, blood pressure, oxygen consumption, speed, grade.
Time frame: -2 weeks, 0 week, 12 weeks
Time to ST-segment deviation>1mm and positive symptoms appear
Time frame: -2 weeks, 0 week, 12 weeks