A prospective, double-blind, randomized controlled clinical study of Shenshuai II granule in delaying the progression of chronic glomerulonephritis (CKD3 stage)

Phase 1

Recruiting

• Conditions: Chronic glomerulonephritis (CKD3 stage)

• Registration Number: ITMCTR2000003740
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. The patients who combined the diagnostic criteria of Western medicine for primary chronic glomerulonephritis (more than 50% of them had renal puncture case reports);
2. Patients aged 18-65 years old;
3. Patients with cgn-ckd3 (GFR 30-59ml/min) were diagnosed;
4. Patients with spleen kidney qi deficiency, dampness turbidity and blood stasis type were classified according to TCM syndrome differentiation;
5. Effective control of hypertension patients (blood pressure 130-90 / 80-60mmmhg), infection, water electrolyte and acid-base balance disorder;
6. Patients treated with ACEI / ARB for 2 weeks or without ACEI / ARB before enrollment;
7. Patients with 0.5g/24h <= 24h urinary protein <= 2.5g/24h;
8. Patients with informed consent.
Those who meet the above criteria can be included in the observation cases, and those who are no in the above items can not be selected as selected cases.

Exclusion Criteria

1. Patients with single kidney or with autosomal dominant polycystic kidney disease, acquired cyst and large renal space occupying disease.
2. Patients diagnosed with arrhythmia, acute renal failure or chronic renal failure with acute exacerbation.
3. Pregnant or preparing for pregnancy and lactation.
4. Those who are known to be allergic to such drugs, psychotic patients and patients who can not cooperate.
5. Patients who are participating in other drug clinical trials or have participated in other clinical trials within 3 months.
6. Patients who have used western medicine glucocorticoid, immunosuppressant and Tripterygium wilfordii preparation within three months.
Those who are yes in any of the above items can not be included in the selected cases.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
TCM syndrome integral;physical examination;Tongue image;Pulse condition;Adverse reactions / events;