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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003765
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic glomerulonephritis (CKD3 stage)

Interventions

Sponsors

Shuguang Hospital affillated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
24 hours Proteinuria;

Secondary

MeasureTime frame
Blood urea nitrogen;Serum creatinine;Urine albumin-to-creatinine ratio;eGFR;

Countries

China

Contacts

Public ContactLin Xu

Shuguang Hospital affillated with Shanghai University of TCM

xulin-02@163.com+86 13916972029

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026