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A Prospective Randomized Controlled Clinical Study on the Intervention of Primary Membranous Nephropathy by Strengthening the Spleen, Benefiting the Kidney and Dispelling the Wind

A Prospective Randomized Controlled Clinical Study on the Intervention of Primary Membranous Nephropathy by Strengthening the Spleen, Benefiting the Kidney and Dispelling the Wind

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065012
Enrollment
Unknown
Registered
2022-10-25
Start date
2020-11-26
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Primary membranous nephropathy

Interventions

Experimental-low risk group:Use the following regimens in addition to basic treatment: 0-24 weeks (trial): the subjects take Moshen granule, one bag Bid, after meals. 24-48 weeks (follow-up) :Continue
Control-low risk group:Use the following regimens in addition to basic treatment: 0-24 weeks (trial): the subjects take Moshen granule simulant, once in the morning and evening, one bag at a time, aft
Experimental-middle-high risk group:Membranous kidney Membranous kidney granules, 1 bag Bid, after meals. Cyclosporine was also taken orally in two equal doses with an interval of 12 hours. Week 24-48
Control-middle-high risk group:Moshen granule simulant 1 bag Bid, after meals. Cyclosporine was also taken orally in two equal doses with an interval of 12 hours. Week 24-48 (follow-up) : The 0-24 wee

Sponsors

First teaching hospital of Tianjin university of traditional chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The age is between 18 and 75 years old; 2. In accordance with the diagnostic criteria of idiopathic membranous nephropathy in western medicine (3rd edition of Nephrology), it is also the first onset with a history of less than 6 months; 3. In line with the syndrome of spleen and kidney deficiency and rheumatism disturbing collaterals (combined with the guiding principles of Clinical Research of New drugs of traditional Chinese Medicine and the Standard of traditional Chinese Medicine Internal Medicine edited by Zhou Zhongying); 4. The patients who had signed informed consent form; 5. CKD1-3 and eGFR (EPI formula) >= 60mL/min, serum albumin > 15g/L

Exclusion criteria

Exclusion criteria: 1. Progressive membranous nephropathy (progressive decline of renal function; Renal biopsy showed necrotizing capillary inflammation and > 50% new lunar body formation), accompanied by other kidney diseases; 2. Patients who have taken or are taking hormones and immunosuppressants; 3. Patients have other rheumatic immune diseases with abnormal indicators; 4. Patients with active hepatitis B and persistent abnormal liver function; 5. Patients with malignant tumor history, HIV infection history, mental history, acute central nervous system diseases and severe gastrointestinal diseases; 6. Life-threatening complications such as serious infection, or serious diseases and dysfunction of other organs; 7. Those who are known to be allergic to the ingredients of the applied Chinese medicine granules; 8. Pregnant or lactating women; 9. Being accepted for other clinical trials.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein quantification;clinical response rate;

Secondary

MeasureTime frame
anti-PLA2R1 antibody;TCM syndrome integral;Serum creatinine;Blood urea nitrogen;Blood uric acid;K;Ca;P;Serum albumin;nrea ACR;eGFR;Triglycerides;Cholesterol;Urea routine examination;

Countries

China

Contacts

Public ContactHongtao Yang

First teaching hospital of Tianjin university of traditional chinese medicine

tjtcmht@126.com+86 13820481917

Outcome results

None listed

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