This trial will evaluate the efficacy and safety of Qishen Yiqi Dripping Pills in treatment of Chronic Heart Failure with reduced ejection fraction resorted from Coronary Heart Disease (Syndrome of Qi Deficiency with Blood Stasis).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
636
Qishen Yiqi Dripping Pills contain Qishen Yiqi Dripping Pills 2 bags(0.52g dripping pills per bag), take orally half an hour after meals, 3 times a day for 12 weeks
Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi Dripping Pills placebo 2 bags(0.52g dripping pills placebo per bag), take orally half an hour after meals, 3 times a day for 12 weeks
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 12 (Larger Distances Represent Better Exercise Functional Capacity).
Time frame: At baseline and at week 12.
Change From Baseline in 6-minute Walk Distance (6MWD) at Week 4 and Week 8.
Time frame: At baseline and at week 4 and week 8.
Change From Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Lower Quality of Life).
Time frame: At baseline and at week 4, week 8 and week 12.
The Disappearance Rate of Heart Failure Symptoms (shortness of breath, fatigue, edema) at Week 4, Week 8 and Week 12.
Time frame: At baseline and at week 4, week 8 and week 12.
Change From Baseline in Traditional Chinese Medicine (TCM) Syndrome Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Sever TCM Syndrome).
Time frame: At baseline and at week 4, week 8 and week 12.
The Total Effective Rate in Traditional Chinese Medicine (TCM) Syndrome at Week 4, Week 8 and Week 12.
Time frame: At baseline and at week 4, week 8 and week 12.
The Number of Participants at Each Level of NYHA Functional Classification and the Proportion of Participants who Improved/Unchanged/Worsened at Week 4, Week 8 and Week 12 Compared With Baseline.
Time frame: At baseline and at week 4, week 8 and week 12.
Change From Baseline in Echocardiographic Measures LVEDD (Left Ventricular End Diastolic Diameter) at Week 12.
Time frame: At baseline and at week 12.
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Bozhou People's Hospital
Bozhou, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
NOT_YET_RECRUITINGAnhui Suzhou Municipal Hospital
Suzhou, Anhui, China
NOT_YET_RECRUITINGXiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFujian Provincial Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGGansu Provincial Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGThe Second Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGQingyang People's Hospital
Qingyang, Gansu, China
NOT_YET_RECRUITINGGuangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine)
Dongguan, Guangdong, China
NOT_YET_RECRUITINGGuangzhou Red Cross Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITING...and 50 more locations
Change From Baseline in Echocardiographic Measures LVEDV (Left Ventricular End Diastolic Volume) at Week 12.
Time frame: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVESV (Left Ventricular End Systolic Volume) at Week 12.
Time frame: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures LVEF (Left Ventricular Ejection Fraction) at Week 12.
Time frame: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures SV (Stroke Volume) at Week 12.
Time frame: At baseline and at week 12.
Change From Baseline in Echocardiographic Measures CO (Cardiac Output) at Week 12.
Time frame: At baseline and at week 12.
Change From Baseline in N-terminal pro-BNP (NT-proBNP) and log(NT-proBNP) at Week 4, Week 8 and Week 12.
Time frame: At baseline and at week 4, week 8 and week 12.
The Proportion of Participants Achieving a Reduction More Than 30% in NT-proBNP at Week 4, Week 8 and Week 12.
Time frame: At baseline and at week 4, week 8 and week 12.
Change From Baseline in Grip Strength-Weight Index at Week 4, Week 8 and Week 12.
Time frame: At baseline and at week 4, week 8 and week 12.
Events Included in the Composite Endpoint of CV Death and Hospitalization Due to Worsening Heart Failure at Week 4, Week 8 and Week 12.
Time frame: At baseline and at week 4, week 8 and week 12.