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

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ClinicalTrials.gov Identifier: NCT02044835
Recruitment Status : Unknown
Verified January 2014 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 24, 2014
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Atherosclerotic Renal Artery Stenosis Drug: Fu-zheng-qu-zhuo oral liquid Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : September 2015

Arm Intervention/treatment
Placebo Comparator: 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.
Experimental: 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.
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: 京药制字Z20063242)




Primary Outcome Measures :
  1. estimated glomerular filtration rate filtration rate [ Time Frame: six month ]
    the change of eGFR during the observation period


Secondary Outcome Measures :
  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) [ Time Frame: six month ]

Other Outcome Measures:
  1. urine protein [ Time Frame: six month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044835


Locations
China, Beijing
Guang anmen Hospital,China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100053
Contact: Shen Li    +86-13681116668    lishen58173@163.com   
Principal Investigator: Shen Li         
Sub-Investigator: Xiangrong Rao         
Sub-Investigator: Huichai Pan         
Sub-Investigator: Lee Wang         
Sub-Investigator: Yu Zhao         
Sub-Investigator: Ming Ye         
Sub-Investigator: Haitao Lu         
Sub-Investigator: Xiujuan Wang         
Sub-Investigator: Fengmei Lian         
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsible Party: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02044835     History of Changes
Other Study ID Numbers: lishen58173
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
atherosclerotic renal artery stenosis, herbal medicine

Additional relevant MeSH terms:
Renal Artery Obstruction
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases