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Clinical Trials associated with TSG-01A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.
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.
Start Date07 May 2020 |
Sponsor / Collaborator- |
TSG-01治疗冠心病慢性心力衰竭(气虚血瘀证)Ⅱa期临床试验
[Translation] Phase IIa clinical trial of TSG-01 for the treatment of chronic heart failure (Qi deficiency and blood stasis syndrome) in patients with coronary heart disease
1. 通过剂量探索评价TSG-01治疗冠心病慢性心力衰竭(气虚血瘀证)的初步有效性和最佳剂量。 2. 观察TSG-01临床应用的安全性。
[Translation] 1. To evaluate the preliminary efficacy and optimal dose of TSG-01 in the treatment of chronic heart failure (Qi deficiency and blood stasis syndrome) caused by coronary heart disease through dose exploration. 2. To observe the safety of TSG-01 in clinical application.
/ Not yet recruitingPhase 3 TSG-01治疗慢性心力衰竭(气虚血瘀证)III期临床试验
[Translation] Phase III clinical trial of TSG-01 for the treatment of chronic heart failure (Qi deficiency and blood stasis syndrome)
评价TSG -01治疗射血分数降低的慢性心力衰竭(气虚血瘀证)的有效性和安全性
[Translation] To evaluate the efficacy and safety of TSG-01 in the treatment of chronic heart failure with reduced ejection fraction (Qi deficiency and blood stasis syndrome)
100 Clinical Results associated with TSG-01
100 Translational Medicine associated with TSG-01
100 Patents (Medical) associated with TSG-01
100 Deals associated with TSG-01