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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | Low dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day |
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| High dose group | Experimental | High dose QiShen YiQi Dripping Pills, 3 bags, take orally after meals, 3 times a day |
|
| Placebo group | Placebo Comparator | QiShen YiQi Dripping Pills placebo, 3 bags, take orally after meals, 3 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose QiShen YiQi Dripping Pills 3 bags | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to weeks 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to weeks 4 and 8 |
| NYHA classification |
| Measure | Description | Time Frame |
|---|---|---|
| Saturation of Peripheral Oxygen | To determine whether the saturation of peripheral oxygen is improved from baseline to week 12 after treatment. | Week 12 |
| Grasp strength body mass index test | To determine whether the grasp strength body mass index is improved from baseline to week 12 after treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei First People's Hospital | Hefei | Anhui | China | |||
| The First Hospital of ANHUI University of Science & Technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38169574 | Derived | He X, Jiang Y, Li S, Liu D, Li Z, Han X, Zhang X, Dong X, Liu H, Huang J, Wang X, Long W, Ni S, Yang Z, Ye T. Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial. Int J Gen Med. 2023 Dec 28;16:6177-6188. doi: 10.2147/IJGM.S436999. eCollection 2023. |
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| High dose QiShen YiQi Dripping Pills 3 bags | Drug | 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 |
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| QiShen YiQi Dripping Pills placebo 3 bags | Drug | 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 |
|
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Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 4,8 and 12.
| 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. | Baseline to weeks 4,8 and 12 |
| Dyspnea, weakness, edema | Symptom disappearance rate(dyspnea, weakness, edema) from baseline to weeks 4,8 and 12. | Baseline to weeks 4,8 and 12 |
| Echocardiogram results |
| Baseline to weeks 4,8 and 12 |
| NT-proBNP | Change from baseline to weeks 4,8 and 12 in NT-proBNP. | 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). | 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. | Week 12 |
| Week 12 |
| 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 |
| Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine | Nanning | Guangxi | China |
| The First Affiliated Hospital of Heilongjiang University of Chinese Medicine | Harbin | Heilongjiang | China |
| Luoyang Third People's Hospital | Luoyang | Henan | China |
| The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan | China |
| Pepole's Hospital of Xinzheng | Zhengzhou | Henan | China |
| Hunan University of Chinese Medicine | Changsha | Hunan | China |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | China |
| Nanjing Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu | China |
| The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Shenyang | Liaoning | China |
| Xi'an Daxing Hospital | Xi'an | Shaanxi | China |
| The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | China |
| The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine | Tianjin | Tianjin Municipality | China |
| Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang | China |
| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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