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A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.

NCT04515290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-10-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

TSG-01

Two tablets of TSG-01 (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; High dose group.

DRUG

TSG-01 and Placebo

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.

DRUG

Placebo

Two tablets of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks.

Sponsors & Collaborators

  • Shanghai Hongyitang Biopharmaceutical Technology Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2022-04-22
Completion
2022-04-22

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515290 on ClinicalTrials.gov