A randomized, double-blind controlled study of Kuoxinfang in the treatment on Deficiency of Both Qi and Yin combined Blood Stasis with Dilated Cardiomyopathy
- Conditions
- Dilated cardiomyopathy
- Registration Number
- ITMCTR2100005127
- Lead Sponsor
- onghua Hospital, Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Those who meet the diagnostic criteria of Western medicine for dilated cardiomyopathy and the TCM syndrome diagnosis of qi-yin deficiency and blood stasis syndrome;
2. Cardiac function classification (NYHA) is II-IV;
3. Aged between 18 and 80 years old;
4. Left ventricular ejection fraction (LVEF) <= 45%;
5. Those who do not apply other drugs outside the regulations during the observation period, and who can adhere to the completion of the treatment and the detection of observation indicators;
6. Agree to participate in clinical trial observation, sign the informed consent form and indicate the date.
1. Combined shock, severe arrhythmia, acute myocardial infarction, pulmonary infarction, infective endocarditis, cardiac tamponade, constrictive pericarditis, left ventricular outflow tract stenosis;
2. Patients with severe liver and kidney insufficiency, hyperthyroidism, hypothyroidism, anemia and electrolyte balance disorders;
3. Pregnant and lactating women;
4. Patients with a history of malignant tumor within 3 years, other clinically significant respiratory system, digestive system, blood system, immune system, mental disease or diseases that may cause serious danger to the patient, and the life expectancy is shorter than the duration of the trial;
5. Allergic constitution or allergy to common drugs;
6. Those who have participated in other Chinese medicine clinical researchers within 3 months or are currently taking other Chinese medicines who are unwilling to stop;
7. Combined with mental illness, or poor compliance with traditional Chinese medicine treatment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eft ventricular ejection fraction ;
- Secondary Outcome Measures
Name Time Method left ventricular mass;Lee heart failure integral;left ventricular end diastolic volume;left ventricular end systolic volume;Traditional Chinese Medicine score;transforming growth factor-ß;Fast filling peak of early left ventricular diastolic filling / late diastolic filling peak;brain natriuretic peptide;Clinical symptoms and cardiac function classification;Minnesota Heart Failure Quality of Life Questionnaire;6 minutes walking distance;