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The purpose of this study is to assess the safety, efficacy and optimal dose of TSG-01, an innovative drug with ginsenosides as its main components, in the treatment of patients with chronic heart failure(CHF). Preclinical studies have revealed that TSG-01 promote myocardial energy metabolism and ATP production, reduce the damage of human pulmonary microvascular endothelial cell connection, resist arrhythmia, and regulate the lipid metabolism disorder caused by myocardial ischemia. Results from CHF animal models(dog, rat) showed that TSG-01 significantly increase coronary blood supply, improve myocardial contractility, reduce heart expansion and pulmonary edema. Besides its potency of improving heart function, TSG-01 was found to induce diuresis without obvious effect on urine potassium in rats. TSG-01 has been approved by CFDA for a clinical trial on the treatment of CHF (Approval No. 2018L03012). A randomized, double-blind, multicenter, placebo-controlled phase IIa clinical trial is now being conducted in 5 hospitals in China. A total of 90 cases of CHF caused by coronary heart disease are included and randomly divided into three groups: high-dose, low-dose of TSG-01 and placebo group. NYHA functional class, 6-minute walk test(6MHWT) distance, NT-proBNP, left ventricular ejection fraction(LVEF), echocardiographic parameters (LVESV, LVEDV, and heart size) and MLHFQ score are measured before, during and after treatment to evaluate the benefits of TSG-01 therapy in patients with CHF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSG-01-H | Experimental | Two tablets of TSG-01 per time. |
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| TSG-01-L | Experimental | One tablet of TSG-01 and One tablet of Placebo per time. |
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| Control | Placebo Comparator | Two tablets of Placebo per time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSG-01 | Drug | Two tablets of TSG-01 (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; High dose group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association (NYHA) Classification | Change from baseline and placebo in NYHA class status. NYHA Classification is a heart function classification which divides impaired cardiac function into four levels according to the action capacity of the patient. And among NYHA classification, Class I represents the mildest symptoms, while Class IV represents the most severe case. | 12th week after intervention |
| Six(6)-minute walk test | To measure the distance that the patient is instructed to walk along a hallway as far as he(or she) can in 6 minutes. | 12th week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change of NT-proBNP (N-Terminal Pro-B-Type Natriuretic Peptide) Level from baseline and placebo | 12th week after intervention | |
| Change in LVEF from screening/baseline as determined by echocardiography | 12th week after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Province Hospital of TCM | Zhengzhou | Henan | 450000 | China | ||
| The first Affiliated Hospital of Henan University of CM |
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| TSG-01 and Placebo | Drug | One tablet of TSG-01 (0.35g/tablet) and one tablet of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; Low dose group. |
|
| Placebo | Drug | Two tablets of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks. |
|
| Change in LVESV from screening/baseline as determined by echocardiography | 12th week after intervention |
| Change in LVEDV from screening/baseline as determined by echocardiography | 12th week after intervention |
| Change in cardiac size from screening/baseline as determined by echocardiography | 12th week after intervention |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | 12th week after intervention |
| Zhengzhou |
| Henan |
| 450000 |
| China |
| Affiliated Hospital of Nanjing University of Chinese Medicine | Nanjing | Jiangsu | 210029 | China |
| Shanghai Shuguang Hospital | Shanghai | Shanghai Municipality | 200021 | China |
| Zhejiang Provincial Hospital of Chinese Medicine | Hangzhou | Zhejiang | 310006 | China |