Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691700
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2020-12-20
Brief Title:
GOREISAN for Heart Failure GOREISAN-HF Trial
Sponsor:
Takeshi Morimoto
Organization:
Kyoto University Graduate School of Medicine
Study Overview
Official Title:
GOREISAN for Heart Failure GOREISAN-HF Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOREISAN-HF
Brief 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
Detailed Description:
Current guidelines recommend the use of loop diuretics as an indication for class I to improve HF symptoms regardless of left ventricular ejection fraction Loop diuretics however are known to activate the renin-angiotensin-aldosterone system and the sympathetic nervous system which could accelerate HF progression Loop diuretics could also cause worsening renal function and electrolyte disturbance and it is desirable to have an alternative drug to loop diuretics to effectively relieve congestive symptoms Goreisan TJ-17 a traditional Japanese medicine composed of five herbal medicines has long been used in Japan to treat impairments of the regulation of body fluid homeostasis including edema and has been less likely to cause renal dysfunction and electrolyte abnormalities We therefore planned a multicenter randomized interventional parallel assignment open-label treatment trial to evaluate the long-term effect of in-hospital initiation of Goreisan when added to standard therapy in patients with worsening congestive heart failure and clear signs of volume overload
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT | REGISTRY | jRCTs051200101 | None |