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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qishen Yiqi Dripping Pills, 2 bags, take orally half an hour after meals, 3 times a day | Experimental |
| |
| Qishen Yiqi Dripping Pills placebo, 2 bags, take orally half an hour after meals, 3 times a day | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qishen Yiqi Dripping Pills 2 bags | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-minute Walk Distance (6MWD) at Week 12 (Larger Distances Represent Better Exercise Functional Capacity). | At baseline and at week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-minute Walk Distance (6MWD) at Week 4 and Week 8. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu | Contact | 022-86343626 | liurui2@tasly.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bozhou People's Hospital | Not yet recruiting | Bozhou | Anhui | China |
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| Qishen Yiqi Dripping Pills placebo 2 bags | Drug | 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 |
|
| 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. | 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). | 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. | 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. | 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. | At baseline and at week 12. |
| Change From Baseline in Echocardiographic Measures LVEDV (Left Ventricular End Diastolic Volume) at Week 12. | At baseline and at week 12. |
| Change From Baseline in Echocardiographic Measures LVESV (Left Ventricular End Systolic Volume) at Week 12. | At baseline and at week 12. |
| Change From Baseline in Echocardiographic Measures LVEF (Left Ventricular Ejection Fraction) at Week 12. | At baseline and at week 12. |
| Change From Baseline in Echocardiographic Measures SV (Stroke Volume) at Week 12. | At baseline and at week 12. |
| Change From Baseline in Echocardiographic Measures CO (Cardiac Output) at Week 12. | 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. | 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. | 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. | 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. | At baseline and at week 4, week 8 and week 12. |
| The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) | Not yet recruiting | Hefei | Anhui | China |
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| Anhui Suzhou Municipal Hospital | Not yet recruiting | Suzhou | Anhui | China |
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| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Fujian Provincial Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| Gansu Provincial Hospital | Not yet recruiting | Lanzhou | Gansu | China |
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| The Second Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | China |
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| Qingyang People's Hospital | Not yet recruiting | Qingyang | Gansu | China |
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| Guangzhou University of Chinese Medicine Dongguan Hospital (Dongguan Hospital of Traditional Chinese Medicine) | Not yet recruiting | Dongguan | Guangdong | China |
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| Guangzhou Red Cross Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Recruiting | Guangzhou | Guangdong | China |
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| Liuzhou People's Hospital | Not yet recruiting | Liuzhou | Guangxi | China |
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| The First Affiliated Hospital of Guangxi University of Chinese Medicine | Not yet recruiting | Nanning | Guangxi | China |
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| The First People's Hospital of Yulin | Not yet recruiting | Yulin | Guangxi | China |
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| Hebei Provincial Hospital of Traditional Chinese Medicine | Not yet recruiting | Shijiazhuang | Hebei | China |
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| The First Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| Affiliated Hospital of North China University of Science and Technology | Not yet recruiting | Tangshan | Hebei | China |
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| The Second Affiliated Hospital of Xingtai Medical College | Not yet recruiting | Xingtai | Hebei | China |
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| Xingtai Central Hospital | Not yet recruiting | Xingtai | Hebei | China |
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| The First Affiliated Hospital of Hebei North University | Not yet recruiting | Zhangjiakou | Hebei | China |
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| Daqing People's Hospital | Not yet recruiting | Daqing | Heilongjiang | China |
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| Heilongjiang Provincial Hospital | Not yet recruiting | Harbin | Heilongjiang | China |
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| Hebi People's Hospital | Not yet recruiting | Hebi | Henan | China |
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| Huaihe Hospital of Henan University | Not yet recruiting | Kaifeng | Henan | China |
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| The First Affiliated Hospital of Henan University | Not yet recruiting | Kaifeng | Henan | China |
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| Luoyang Third People's Hospital | Not yet recruiting | Luoyang | Henan | China |
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| Puyang Oilfield General Hospital | Not yet recruiting | Puyang | Henan | China |
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| The Third Affiliated Hospital of Xinxiang Medical University | Not yet recruiting | Xinxiang | Henan | China |
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| Xinxiang Central Hospital | Not yet recruiting | Xinxiang | Henan | China |
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| Huangshi Central Hospital | Not yet recruiting | Huangshi | Hubei | China |
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| Shiyan People's Hospital | Not yet recruiting | Shiyan | Hubei | China |
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| Wuhan Third Hospital | Not yet recruiting | Wuhan | Hubei | China |
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| Yichang Central People's Hospital | Not yet recruiting | Yichang | Hubei | China |
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| The First Affiliated Hospital of Hunan University of Chinese Medicine | Not yet recruiting | Changsha | Hunan | China |
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| Xiangya Hospital, Central South University | Not yet recruiting | Changsha | Hunan | China |
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| The First Affiliated Hospital of University of South China | Not yet recruiting | Hengyang | Hunan | China |
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| Affiliated Hospital of Nanjing University of Chinese Medicine | Not yet recruiting | Nanjing | Jiangsu | China |
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| Pingxiang People's Hospital | Not yet recruiting | Pingxiang | Jiangxi | China |
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| Jinzhou Central Hospital | Not yet recruiting | Jinzhou | Liaoning | China |
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| Panjin Central Hospital | Not yet recruiting | Panjin | Liaoning | China |
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| Liaoning Provincial People's Hospital | Not yet recruiting | Shenyang | Liaoning | China |
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| Chifeng Municipal Hospital | Not yet recruiting | Chifeng | Neimenggu | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | China |
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| Xi'an Daxing Hospital | Not yet recruiting | Xi'an | Shaanxi | China |
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| Affiliated Hospital of Shaanxi University of Chinese Medicine | Not yet recruiting | Xianyang | Shaanxi | China |
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| Heze Municipal Hospital | Not yet recruiting | Heze | Shandong | China |
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| Shandong Second Provincial People's Hospital | Not yet recruiting | Jinan | Shandong | China |
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| Jining First People's Hospital | Not yet recruiting | Jining | Shandong | China |
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| Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| First Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | China |
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| Yuncheng Central Hospital | Not yet recruiting | Yuncheng | Shanxi | China |
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| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Not yet recruiting | Chengdu | Sichuan | China |
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| Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | China |
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| Mianyang Traditional Chinese Medicine Hospital | Not yet recruiting | Mianyang | Sichuan | China |
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| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Fourth Central Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Fuwai Yunnan Cardiovascular Hospital | Not yet recruiting | Kunming | Yunnan | China |
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| The Second Affiliated Hospital of Zhejiang Chinese Medical University | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Lishui Central Hospital | Not yet recruiting | Lishui | Zhejiang | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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