A comparative study for the effect of Wen-Yang Hua-Ji method of Chinese medicine in the treatment of membranous nephropathy

Not Applicable

• Conditions: Membranous Nephropathy

• Registration Number: ITMCTR2000003544
• Lead Sponsor: Beijing Hospital 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients aged between 18 and 75 years old;
2. The patients who met the diagnostic criteria of Western medicine for membranous nephropathy, and met the requirement that the 24-hour urine protein quantity of the enrolled patients was still more than 5g after 12 weeks of follow-up (i.e., they could not spontaneously relieve);
3. Patients who meet the diagnostic criteria of syndrome accumulation of Yang deficiency syndrome in TCM;
4. Patients who have signed informed consent form;
5. Ckd1-3, EGFR (EPI formula) >=40ml / min, serum albumin > 15g / L.

Exclusion Criteria

1. Patients with progressive membranous nephropathy (progressive decline of renal function; necrotizing capillary inflammation and > 50% crescentic formation) in renal biopsy, accompanied with IgA nephropathy, diabetic nephropathy and other kidney diseases;
2. Patients with abnormal antinuclear antibody, double stranded DNA, ANCA or other immune diseases;
3. Patients with active hepatitis B and abnormal transaminase in continuous liver function test;
Patients with history of HIV / AIDS, severe gastrointestinal cancer, or history of central nervous system malignancy; 4;
5. Patients with life-threatening complications such as severe infection or severe diseases and dysfunction of other organs;
6. The subjects known to be allergic to the components of the traditional Chinese medicine granules used;
7. Pregnant or lactating women;
8. Subjects undergoing other clinical trials.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Blood albumin;TCM syndrome scores;24-hour urine protein;Anti-PLA2R Antibody;

Secondary Outcome Measures

Name	Time	Method
Serum creatinine;Triglyceride;Total Cholesterol;Blood urea nitrogen;