Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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 and a 12-month treatment period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Fangshan Hospital of Traditional Chinese Medicine,; Peking University First Hospital

Criteria

Inclusion Criteria:

(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 Criteria:

(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.