A Clinical Study of the Efficacy of Fuzhenghuayu Granules Combined with Losartan in the Treatment of Primary Glomerulonephritis

Phase 1

Recruiting

• Conditions: Chronic glomerulonephritis (CKD3 stage)

• Registration Number: ITMCTR2000003765
• Lead Sponsor: Shuguang Hospital affillated with Shanghai University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged from 18 to 65 years;
2. Diagnosed with primary glomerulonephritis and included in the period of CKD G3;
3. 0.5g <= 24 h proteinuria <= 3.0g;
4. Blood pressure can be controlled under 140/90mmHg;
5. Severe infection, electrolyte disorders or acid-base disturbance can be controlled while the blood potassium value is within the normal range;
6. Traditional Chinese medicine syndrome conform liver-kidney yin deficiency;
7. Run-in period: two weeks. At the beginning and end of the run-in period, patients must undergo the following tests twice, and only those who meet the standards can enter the trial. GFR: 3059 mL/min/1.73m2, 0.5g <= 24 h proteinuria <= 3.0g, Bp <= 140/90 mmHg;
8. Obtain the agreement of patients, and signed informed consent file.

Exclusion Criteria

1. Henoch-Schonlein purpura nephritis, lupus nephritis, systemic small vasculitis kidney damage, gouty nephropathy, Myeloma nephropathy and other secondary nephropathy;
2. Take the glucocorticoid, immunosuppressants and triptolide medications in the last 3 months;
3. Take other Chinese patent medicine and decoction whicn can reduce proteinuria in the last 2 weeks;
4. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patients life;
5. Pregnant or lactating women;
6. Allergic predisposition or known to be allergic to the drug composition;
7. Blood presser < 90/60mmHg;
8. Patient with unilateral or bilateral renal artery stenosis;
9. Patients with mental disorders and poor compliance;
10. Patiens are suspected or confirmed with alcohol, drug abuse history;
11. Patines who is participating in another clinical study at the same period.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24 hours Proteinuria;

Secondary Outcome Measures

Name	Time	Method
Blood urea nitrogen;Serum creatinine;Urine albumin-to-creatinine ratio;eGFR;