Evaluation of hua tuo restorative pill treatment of coronary heart disease angina pectoris (block phlegm and blood stasis syndrome) safety and efficacy of randomized, double-blind, parallel-group, multicenter clinical trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Test group:Take 8g of Hua Tuo Zai Zai Wan orally each time, 3 times/day;Control group:Take 8g of Hua Tuo Zai Zai Wan simulant orally each time, 3 times daily;Test group:Oral administration of Hua Tuo Zai Zai Wan 8g + 5 tablets of simulated Dang Ju tablets each time, 3 times/day;Control group:Take 5 tablets of Danggu tablets + 8g of Hua Tuo Zai Zai Wan simulant orally each time; CONDITION: Coronary heart disease angina pectoris PRIMARY OUTCOME: Attack frequency of angina pectoris;Angina pectoris combined efficacy rate; SECONDARY OUTCOME: Measured and decreasing values of the number of angina attacks;Angina duration measured versus decreasing values;Nitroglycerin use measured and decreased values;Nitroglycerin stopping reduction rate;Disappearance rate of angina pectoris;Total angina score;Electrocardiographic efficacy;Chinese medicine evidence of efficacy;Measured and decreasing values of total TCM evidence points;Disappearance rate of single indicators of TCM symptoms;Measured and decreasing values of experimental indicators of active plate; INCLUSION CRITERIA: ?Those who meet the diagnostic criteria of coronary angina pectoris. ? Those who meet the diagnostic criteria of stable exertional angina. ?Those who meet the diagnostic criteria of exertional angina ?, ? and ? (the first stage mainly includes grade ? and ?). ?Those who meet the criteria for identification of phlegm‐stasis blocking evidence in Chinese medicine. ? Patients with an average of =2 episodes of angina pectoris per week in the 4 weeks prior to enrollment. ?Plain ECG with ischemic manifestations: ST‐segment decrease = 0.1mv and/or R‐wave as the dominant association T‐wave inversion and deep > 0.2mv; plain ECG with ischemic manifestations. 0.2 mv; if the ST segment of general ECG decreased =0.05 mv and <0.1 mv, the exercise plate test was positive (for details, see the protocol).(Annex: Exercise plate test SOP). ? Age: 35‐70 years old (35‐65 years old in the first stage, and relaxed to 70 years old in the second stage). ? Subj
Epistemonikos ID: c1b61c2a81bba7dc9d879a56d9999d214aebf76f
First added on: Feb 20, 2024