The Evaluation Studies of Curative Effect of Fu-zheng-qu-zhuo Oral Liquid in Treatment of Ischemic Nephropathy

NCT02044835 | Unknown Phase 2 DMC

• 1 other identifier: lishen58173
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Renal Artery Stenosis

Keywords

atherosclerotic renal artery stenosis, herbal medicine

Outcome Measures

Primary Outcomes (1)

• estimated glomerular filtration rate filtration rate

  the change of eGFR during the observation period

  six month

Secondary Outcomes (1)

• 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)

  six month

Other Outcomes (1)

• urine protein

  six month

Study Arms (2)

OMT controll

PLACEBO COMPARATOR

placebo 20 ml every time, three times a day, combined with optimal medical therapy of internal medicine, including anti-platelet therapy and other protocol-driven medical therapies to control blood pressure and glucose and lipid levels in accordance with guidelines.

herbal treatment

EXPERIMENTAL

Fu-zheng-qu-zhuo oral liquid ( herbal medicine) 20 ml every time, three times a day,combined with optimal medical therapy of internal medicine, including anti-platelet therapy and other protocol-driven medical therapies to control blood pressure and glucose and lipid levels in accordance with guidelines.

Drug: Fu-zheng-qu-zhuo oral liquid

Interventions

Fu-zheng-qu-zhuo oral liquid DRUG

Fu-zheng-qu-zhuo oral liquid was composed of Ginseng, Astragalus, Angelica root, Tuckahoe, Rhubarb, etc. It was producted by manufacturing laboratory of Guang'anmen Hospital, China Academy of Chinese Medical Science (License code: 京药制字Z20063242)

herbal treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Met the ARAS diagnosis: renal angiography or magnetic resonance angiography (MRA) shows renal artery with unilateral or bilateral stenosis at least 50%，and with artery atheromatous plague;
• Meeting with the diagnostic criteria of the K/DOQI chronic kidney disease （eGFR\<90ml/min）：light or moderate damage to kidney function，Scr\<265.2µmol/L(3.0mg/dl).

You may not qualify if:

• Patients with renal artery stenosis which had been suspected or final diagnosed to be Fibromuscular dysplasia or Takayasu arteritis;
• Blood pressure did not meet the target (\<140/90mmHg) after combinedly taking more three kinds of antihypertensive agents with maximum dose;
• Poor control of blood sugar in patients with Diabetes ( glycosylated hemoglobin 8.0% or higher in the recent month);
• History of peptic ulcer，with Gastrointestinal bleeding in the recent 6 months;
• decompensated cirrhosis;
• Hematologic disease or bleeding tendency;
• Repeated episodes of pulmonary edema, congestive heart failure, acute myocardial infarction, cerebral infarction and cerebral hemorrhage in recent 3 months;
• Suffering from malignant tumor and predicting life span less than 1 year.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang anmen Hospital,China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

CN (1)