GOREISAN for Heart Failure (GOREISAN-HF) Trial
NCT04691700 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1179
Last updated 2026-01-06
Summary
The objective of the GOREISAN-HF trial is to assess the effect of the administration of Goreisan (TJ-17) plus standard therapy compared to standard therapy alone on the improvement rate of cardiac edema and clinical outcomes in worsening congestive heart failure with volume overload.
Conditions
- Heart Failure
- Edema
- Traditional Japanese Medicine
- Kampo Medicine
- Clinical Trial
Interventions
- DRUG
-
Goreisan
Add Goreisan 7.5g per day to standard treatment with the intention to reduce or discontinue the existing diuretics
- DRUG
-
Standard Treatment
Standard therapy without Goreisan
Sponsors & Collaborators
-
Takeshi Morimoto
lead OTHER
Principal Investigators
-
Takeshi Kimura, MD, PhD · Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-19
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Japan
Study Locations
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