Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3
Huaiqihuang Granules in the Treatment of Primary Glomerulonephritis of Stage CKD3: a Randomized, Double-blind, Double-simulation, Positive Parallel Control Multi-center Clinical Study
The First Affiliated Hospital of Dalian Medical University
466 participants
Jun 30, 2020
INTERVENTIONAL
Conditions
Summary
This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.
Eligibility
Inclusion Criteria6
- Diagnosed as primary glomerulonephritis by renal biopsy
- Male or female, 18≤age≤65
- Blood pressure can be effectively controlled at or below 140/90mmHg
- mL/（min.1.73m2）≤ eGFR\<60mL/（min.1.73m2）
- hour urine protein ration ≤ 2.0g/24h
- The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Exclusion Criteria11
- Diagnosed as secondary glomerulonephritis
- Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or ACEIs, without a two weeks washout period
- Blood pressure \< 90/60 mmHg
- Serum potassium \> 5.5 mmol/L
- Serum albumin \< 30g/L
- Unilateral or bilateral renal artery stenosis
- Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
- Having comorbidities that affect the progression of primary glomerulonephritis (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis, Diabetes, and Gout)
- Allergic to the Huaiqihuang Granule or valsartan
- Participating in another clinical trial
- Investigators do not think it suitable for a participant to join this study
Interventions
Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.
Locations(34)
View Full Details on ClinicalTrials.gov
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NCT04263922