This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).
QiShen YiQi Dripping Pills are oral, compound traditional chinese medicine prepatations. This study will evaluate the efficacy and safety and the best effective dose of QiShen YiQi Dripping Pills in the treatment of chronic heart failure with decreased ejection fraction of CHD (Qi deficiency and blood stasis syndrome).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
Low dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 2 bags(0.52g dripping pills per bag) and QiShen YiQi Dripping Pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
High dose QiShen YiQi Dripping Pills contain QiShen YiQi Dripping Pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
QiShen YiQi Dripping Pills placebo contain QiShen YiQi Dripping Pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
Hefei First People's Hospital
6-Minutes-Walking-Test (6MWT) in week 12
Change from baseline to weeks 12 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Time frame: Baseline to weeks 12
6-Minutes-Walking-Test (6MWT) in weeks 4 and 8
Change from baseline to weeks 4 and 8 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Time frame: Baseline to weeks 4 and 8
NYHA classification
Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.
Time frame: Baseline to weeks 4,8 and 12
Traditional Chinese Medicine Syndrome Score
Change from baseline to weeks 4,8 and 12 in Traditional Chinese Medicine Syndrome Score. There were 3 clinical primary symptoms, 4 clinical secondary symptoms, tongue picture and pulse condition evaluated as TCM symptoms, which was defined as TCM syndrome score. The standard of TCM primary symptoms scored as without 0, light 2, medium 4, heavy 6 points. The standard of TCM secondary symptoms scored as without 0, with 1 points. Tongue picture and pulse condition did not count.
Time frame: Baseline to weeks 4,8 and 12
Dyspnea, weakness, edema
Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12.
Time frame: Baseline to weeks 4,8 and 12
Echocardiogram results
1. Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic diameter(LVEDD) measured by echocardiography; 2. Change from baseline to weeks 4,8 and 12 in left ventricular end diastolic volume(LVEDV) measured by echocardiography; 3. Change from baseline to weeks 4,8 and 12 in left ventricular end systolic volume(LVESV) measured by echocardiography; 4. Change from baseline to weeks 4,8 and 12 in left ventricular ejection fraction(LVEF) measured by echocardiography; 5. Change from baseline to weeks 4,8 and 12 in stroke volume(SV) measured by echocardiography; 6. Change from baseline to weeks 4,8 and 12 in cardiac output(CO) measured by echocardiography.
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Hefei, Anhui, China
The First Hospital of ANHUI University of Science & Technology
Huainan, Anhui, China
Suzhou Municipal Hospital
Suzhou, Anhui, China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Dongguan TCM Hospital
Dongguan, Guangdong, China
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, China
The Affiliated TCM Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Zhong Shan Hospital of Chinese Medicine
Zhongshan, Guangdong, China
...and 13 more locations
Time frame: Baseline to weeks 4,8 and 12
NT-proBNP
Change from baseline to weeks 4,8 and 12 in NT-proBNP.
Time frame: Baseline to weeks 4,8 and 12
Minnesota Living With Heart Failure Questionnaire(MLHFQ)
Change from baseline to weeks 4,8 and 12 in Minnesota Living With Heart Failure Questionnaire(MLHFQ). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items representing different degrees of impact of HF on health-related quality of life. Every item in this questionnaire scores from 0 (none) to 5 (very much) and the total items score from 0 (none) to 105 (very much).
Time frame: Baseline to weeks 4,8 and 12
Cardiovascular adverse events
To determine whether the incidence of cardiovascular adverse events during the study period was superior to placebo.
Time frame: Week 12