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Evaluate the efficacy and safety of Jia Shen Tablets in patients with Chronic Heart Failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator |
| |
| Low dose group | Experimental |
| |
| High dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jia Shen Tablet Placebo | Drug | Jia Shen Tablet Placebo contains 4 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 12. | Baseline and Week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minutes-Walking-Distance (6MWD): the change from baseline to Week 6. | Baseline and Week 6. | |
| NT-proBNP: the change from baseline to Week 6 and 12. | Baseline, Week 6 and 12. | |
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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 |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Tianjin University of traditional Chinese | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Low dose Jia Shen Tablet | Drug | Low dose Jia Shen Tablet contains 2 tablets (0.47 g per tablet) and 2 placebo tablets (0.47 g per placebo tablet),take orally, 2 times a day for 12 weeks |
|
| High dose Jia Shen Tablet | Drug | High dose Jia Shen Tablet contains 4 tablets (0.47 g per tablet),take orally, 2 times a day for 12 weeks |
|
| NT-proBNP: the proportion of patients demonstrating a decrease in NT-proBNP level of at least 30%. |
| Baseline, Week 6 and 12. |
| Echocardiogram: Measurements will be made of the left ventricle's end diastolic diameter (LVEDD), end diastolic volume (LVEDV), end systolic volume (LVESV), left ventricular ejection fraction(LVEF), stroke volume (SV), and cardiac output (CO). | Baseline and Week 12. |
| NYHA functional classification: Measure the percentage of participants whose NYHA functional classification is improved/worsened/unchanged from baseline to Week 6 and 12. | Baseline, Week 6 and 12. |
| MLHFQ Score: the change from baseline to Week 6 and 12. | The MLHFQ consists of 21 elements representing varying degrees of impact of HF on health related quality of life. Each item in this questionnaire is scored from 0 (none) to 5 (very much), and the total item score is from 0 (none) to 105 (very much). | Baseline, Week 6 and 12. |
| Traditional Chinese Medicine(TCM) Syndrome Score: change from baseline to Week 6 and 12. | There were 3 primary symptoms and 4 secondary symptoms. The state of the tongue and pulse is used to evaluate and score TCM symptoms. 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, light 1, medium 2, heavy 3 points. Tongue picture and pulse condition did not count. | Baseline, Week 6 and 12. |
| Dyspnea, weakness and edema: the rate of disappearance of the symptoms (dyspnea, weakness, and edema) from baseline to Week 6 and 12. | Baseline, Week 6 and 12. |
| Cardiovascular Adverse Events: Incidence of Cardiovascular AEs(cardiovascular death, hospitalization for worsening heart failure, hospitalization for nonfatal myocardial infarction, hospitalization for nonfatal stroke). | Week 12. |