Status:
COMPLETED
Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Fangshan Hospital of Traditional Chinese Medicine,
Peking University First Hospital
Conditions:
Stage 3 Chronic Kidney Disease
Stage 4 Chronic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
a prospective, multicenter (outpatient clinics of the three participating hospitals in Beijing), double blinded and randomized placebo-controlled study. The study consisted of a 2-week run-in period ...
Eligibility Criteria
Inclusion
- (1) Signed informed consent and aged from 18 to 75 years old. (2) Chronic renal diseases with Glomerular Filtration Rate (GFR) estimated using the CKD Epidemiology Collaboration (CKD-EPI) equation between 15 and 59 ml/min per 1.73 m2 on at least 2 dates separated by at least 90 days but no more than 6 month (the CKD defining window period). (3)Not received other TCM treatment for at least 2 weeks.
Exclusion
- (1) 50% increase in serum creatinine occurring within 2 month before screening. (2) Immediate need for dialysis. (3) Myocardial infarction or cerebrovascular accident in the 6 month preceding the trial. (4) Connective-tissue disease, obstructive uropathy and renal transplantation. (5) Patients with severe disease in other organs or cancer, psychotic diseases, and active tuberculosis. (6) Treatment with corticosteroid and immunosuppressive agents in recent 3 month. Hemoglobin (Hb) less than 80 g/L. (7) Diabetes Mellitus with uncontrolled Blood Sugar ( glycated hemoglobin （HbA1c） \>8.0%). (8) Enrolled in other trials. (9) Women in pregnancy or lactation.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT02275468
Start Date
June 1 2010
End Date
October 1 2014
Last Update
October 27 2014
Active Locations (3)
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1
Guang anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100053
2
Fangshan Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
3
Guang'an Men Hospital South
Beijing, China