Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT02044835
Status:
UNKNOWN
Last Update Posted:
2014-01-24
First Post:
2014-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation Studies of Curative Effect of Fu-zheng-qu-zhuo Oral Liquid in Treatment of Ischemic Nephropathy
Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2014-01
Last Known Status:
RECRUITING
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:
None
Brief Summary:
• Background: Since evidence show that renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis\[1\], the aim of our study was to confirm Fu-zheng-qu-zhuo (FZQZc) oral liquid, a herbal medicine, combined with optimal medical therapy of internal medicine (OMT), including anti-platelet therapy and other protocol-driven medical therapies to control blood pressure and glucose and lipid levels in accordance with guidelines,resulted in greater renal function protection in patients with atherosclerotic renal artery stenosis ( ARAS) compared with OMT alone.
Methods : A randomized, placebo-controlled, single centre clinical design. Sixty patients with diagnosed atherosclerotic renal artery stenosis and had chronic kidney disease stage 3 will be recruited, and will be randomized into two groups in a 1:1 ratio ( FZQZ and placebo Group, 30 respectively). FZQZ Oral liquid or placebo 20 ml every time, three times a day for different groups, meanwhile, all participants in both treatment groups received OMT, 6 months therapeutic period. Serum creatinine, estimated glomerular filtration rate(eGFR), urine protein, and cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy) will be compared between the Groups as the outcome.
Methods : A randomized, placebo-controlled, single centre clinical design. Sixty patients with diagnosed atherosclerotic renal artery stenosis and had chronic kidney disease stage 3 will be recruited, and will be randomized into two groups in a 1:1 ratio ( FZQZ and placebo Group, 30 respectively). FZQZ Oral liquid or placebo 20 ml every time, three times a day for different groups, meanwhile, all participants in both treatment groups received OMT, 6 months therapeutic period. Serum creatinine, estimated glomerular filtration rate(eGFR), urine protein, and cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy) will be compared between the Groups as the outcome.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: