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

Atherosclerotic Renal Artery Stenosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02044835
• Other study ID #: lishen58173
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 22, 2014
• Last updated: January 22, 2014
• Start date: January 2013

Study information

• Verified date: January 2014
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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).

Exclusion Criteria:

1. Patients with renal artery stenosis which had been suspected or final diagnosed to be Fibromuscular dysplasia or Takayasu arteritis;

2. Blood pressure did not meet the target (<140/90mmHg) after combinedly taking more three kinds of antihypertensive agents with maximum dose;

3. Poor control of blood sugar in patients with Diabetes ( glycosylated hemoglobin 8.0% or higher in the recent month);

4. History of peptic ulcer,with Gastrointestinal bleeding in the recent 6 months;

5. decompensated cirrhosis;

6. Hematologic disease or bleeding tendency;

7. Repeated episodes of pulmonary edema, congestive heart failure, acute myocardial infarction, cerebral infarction and cerebral hemorrhage in recent 3 months;

8. Suffering from malignant tumor and predicting life span less than 1 year.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerotic Renal Artery Stenosis
• Renal Artery Obstruction

Intervention

Drug:
• Fu-zheng-qu-zhuo oral liquid
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: ????Z20063242)

Locations

Country	Name	City	State
China	Guang anmen Hospital,China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	urine protein		six month	No
Primary	estimated glomerular filtration rate filtration rate	the change of eGFR during the observation period	six month	No
Secondary	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	No