To explore the effectiveness of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill in the elderly population with coronary heart disease and the safety of multiple medications
This study is a prospective, double-blind, randomized controlled clinical trial, which aims to explore the effectiveness and safety of polypharmacy in the elderly population of stable angina patients, and make up for the limitations of clinical treatment. As commonly used traditional Chinese medicine preparations, the efficacy and safety of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill have been supported by previous studies, providing a solid theoretical basis. The study design adopts scientific and reliable clinical trial methods, and the treatment plan combines Western medicine treatment and traditional Chinese medicine intervention, which has high clinical application value. In the actual clinical treatment, due to the complex medical history of elderly patients, they often have multi-vessel coronary artery lesions, and the treatment tolerance is worse than that of young people, so although they are accompanied by angina pectoris, the treatment methods are relatively limited. This study provides evidence of the efficacy and safety of drugs for the treatment of elderly patients with angina pectoris through the combination of Chinese and Western treatments, which can help make up for the dilemma of limited clinical treatment methods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
The experimental group used compound Danshen dripping pills as an intervention on the basis of conventional western medicine treatment.
The experimental group used Qishen Yiqi dripping pills as an intervention on the basis of conventional western medicine treatment.
Intervention with placebo on the Basis of optimal medical treatment
Fuwai hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
RECRUITINGSeattle angina questionnaire
The Seattle Angina Questionnaire (SAQ) consists of five distinct dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each dimension is scored independently, with a possible range of 0 to 100 points. A higher score on any SAQ dimension indicates a better patient condition or experience.
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Canadian Cardiovascular Society grading of angina pectoris
The Canadian Cardiovascular Society grades angina pectoris ranges from grade 1 to grade 4. Higher grade indicates worse patients' condition.
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Minnesota Living with Heart Failure Questionnaire
The Minnesota Living with Heart Failure Questionnaire's score ranges from 0 to 105. Higher score indicates worse patients' condition.
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire's score ranges from 0 to 100. Higher score indicates better patients' condition.
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Traditional Chinese Medicine Syndrome Score
The Traditional Chinese Medicine Syndrome Score ranges from 0 to 30. Higher score indicates worse patients' condition.
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Number of angina attacks
The average number of angina attacks per week
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Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
Nitroglycerin dosage
Patient's weekly dose of nitroglycerin, measured in mg
Time frame: 8 weeks. If the change is not significant, it can be extended to 12 weeks.