Based on the association study of intestinal microecology and TCM tongue diagnosis study on the establishment of a precise diagnosis and treatment system for membranous nephropathy in traditional Chinese medicine

Phase 1

Recruiting

• Conditions: CKD M

• Registration Number: ITMCTR2100004625
• Lead Sponsor: onghua Hospital Affiliated to Shanghai University 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Idiopathic membranous nephropathy group:
(1) It meets the diagnostic criteria of Western medicine and is confirmed to be an IMN patient by renal biopsy and clinical examination;
(2) 24-hour urine protein quantitative >= 1g, eGFR > 30ml/min/1.73m2;
(3) 18-75 years old, regardless of gender or ethnicity;
(4) The patient gave informed consent and signed the informed consent form.
2. CKD group of non-membranous nephropathy:
(1) Non-MN patients who meet the diagnostic criteria of Western medicine and are confirmed by renal biopsy;
(2) 24-hour urine protein quantitative >= 1g, eGFR > 30ml/min/1.73m2;
(3) 18-75 years old, regardless of gender or ethnicity;
(4) The patient gave informed consent and signed the informed consent form.
3. Healthy volunteer group:
(1) Healthy adults, between the ages of 18-75, regardless of gender or ethnicity;
(2) The patient gave informed consent and signed the informed consent form.

Exclusion Criteria

(1) Rapidly progressing CKD;
(2) Merge other pathological types of MN;
(3) Have received immunosuppressant or cytotoxic drug treatment for more than 4 weeks in the past 6 months;
(4) Have received glucocorticoids (prednisone or prednisone) at a dose of more than 20 mg/d for more than 4 weeks in the past 6 months;
(5) Those with life-threatening complications such as severe infections;
(6) Those with positive HBV serological indicators other than HbsAb and those with abnormal transaminase in continuous liver function tests;
(7) Patients with malignant tumors or patients with malignant tumor history, history of HIV infection, history of mental illness, acute central nervous system disease, severe gastrointestinal disease, and patients who are prohibited from using immunosuppressive agents;
(8) Poor blood sugar control, fasting blood sugar >= 7.0mmol/L;
(9) Pregnant or lactating women;
(10) Undergoing other clinical trials and research;
(11) Combined with serious diseases and dysfunction of other organs;
(12) Taking probiotics for treatment in the past month;
(13) Take antibiotic treatment in the past 3 months;
(14) Hypertension has poor blood pressure control, blood pressure >= 140/90mmHg;
(15) Those who are deemed unsuitable to participate in this research after the comprehensive evaluation of the research.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Intestinal flora;Scr;