Evaluation of clinical effect of compound Shelong Capsule on urinary protein in membranous nephropathy

Phase 1

• Conditions: Idiopathic membranous nephropathy

• Registration Number: ITMCTR2200006490
• Lead Sponsor: Shanxi Hospital of Traditional Chinese Medicine

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) Consistent with the clinical diagnosis of chronic nephritis and stage I-II pathological diagnosis of membranous nephropathy;
(2) TCM syndrome differentiation belongs to the syndrome of mutual obstruction of dampness and stasis;
(3)0.3g/24h= 24h urinary protein quantification <3.5g/24h;
(4) Serum creatinine =176µmol/L, or glomerular filtration rate (GFR)= 60mL /(min·1.73m2);
(5) Aged between 16 and 65, regardless of gender;
(6) Acute aggravating factors such as infection, electrolyte disturbance, severe hypertension, hyperlipemia and hyperglycemia can be effectively controlled;
(7) Those who voluntarily participate in the experiment and sign the informed consent.

Exclusion Criteria

(1) Patients with serious primary diseases of the heart, brain, liver and hematopoietic system, type 1 diabetes, or other serious diseases affecting their survival;
(2) 24-hour urine protein quantification =3.5g/24h or < 0.4g/24h;
(3) serum creatinine =177µmol/L, or serum creatinine clearance (GFR)<60ml/(min·1.73m2);
(4) pregnant or lactating women;
(5) Persons with allergic constitution who have a history of drug allergy or are known to be allergic to the drug components in the test;
(6) Those who are taking similar study drugs or antihypertensive drugs with protein-lowering effect or are currently taking hormone or immunosuppressive therapy;
(7) mentally ill or legally disabled persons;
(8) Those who have no fixed place to work and are easy to fall off;
(9) Participants in another clinical drug trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Total plasma protein;24 hours urinary protein excretio;Serum creatinine;plasma albumin;

Secondary Outcome Measures

Name	Time	Method
rine analysis;Urea nitrogen;Total cholesterol;triglycerides;