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

NCT ID: NCT02044835

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

OMT controll

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.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

herbal treatment

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.

Group Type: EXPERIMENTAL

Fu-zheng-qu-zhuo oral liquid

Intervention Type: 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)

Interventions

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: 京药制字Z20063242)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guang anmen Hospital,China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shen Li

Role: primary

lishen58173@163.com

+86-13681116668

Other Identifiers

lishen58173

Identifier Type: -

Identifier Source: org_study_id