NCT02275468CompletedPhase 2
Fu-zheng-qu-zhuo Oral Liquid Combined With Integrated Therapy Improves Renal Function in Patients of Chronic Kidney Disease Stage 3 and 4，a Randomized Placebo-Control Clinical Trial
Guang'anmen Hospital of China Academy of Chinese Medical Sciences3 sites in 1 country124 target enrollmentStarted: June 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 124
- Locations
- 3
- Primary Endpoint
- composite end point
Study Overview
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 and a 12-month treatment period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Fu-zheng-qu-zhuo oral liquid Group
Experimental
Patients of FZQZ Group received Fu-zheng-qu-zhuo (FZQZ) oral liquid 20ml every time, and three times a day combined with integrated therapy. The integrated therapy was same to Control Group.
Intervention: Fu-zheng-qu-zhuo (FZQZ) oral liquid (Drug)
Outcomes
Primary Outcomes
composite end point
Time Frame: 12 month after the treatmnet and 3 years of the follow up time
end stage renal disease (defined by the need for long-term dialysis or renal transplantation, or eGFR\<15ml/min) and all cause of death
Secondary Outcomes
- the slope of the eGFR versus observation time(12 month after the treatment)
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Unknown
Not Applicable
Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 InfectionCOVID-19Child, OnlyNCT05507489The Affiliated Hospital of Qingdao University240
Completed
Not Applicable
Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCIChronic Stable AnginaNCT06224582China National Center for Cardiovascular Diseases320
Unknown
Phase 4
Clinical Evaluation of the Combination of Symptoms and Symptoms With General Treatment for Acute Hemorrhagic StrokeAcute Hemorrhagic StrokeNCT04946474Peking University Third Hospital520
Recruiting
Phase 4
International Clinical Study of Zhizhu Kuanzhong CapsulePostprandial Distress SyndromeFunctional DyspepsiaNCT03825692Xiyuan Hospital of China Academy of Chinese Medical Sciences480
Unknown
Not Applicable
Clinical Trial for Post-marketing Evaluation of Sheng Bai Oral LiquidNon-small-Cell Lung CancerNCT03413358BeiJing Yijiayi Medicine Techonoloy Co., Ltd.240