IgA nephropathy
Conditions
Interventions
Treatment group:Shenqi Yishen Granules + Irbesartan
Control Group:Chinese herbal placebo + Irbesartan
Sponsors
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for IgA nephropathy according to Western medicine and CKD stages 1-2; (2) Meets the diagnostic criteria for "qi and yin deficiency syndrome" according to Traditional Chinese Medicine; (3) Age between 18 and 75 years, gender; (4) Infection, acidosis, electrolyte imbalance, hypertension, etc., are well controlled; (5) No failure of other organ functions; (6) Have good compliance, have not participated in other clinical trials in the past six months; are informed and voluntarily willing to participate in the clinical study.
Exclusion criteria
Exclusion criteria: (1) Immediate dialysis treatment is required; currently undergoing treatment with hormones, non-steroidal anti-inflammatory drugs, or immunosuppressive agents; (2) Patients with acute infectious diseases or those under surgical or traumatic stress; (3) Patients with chronic infectious diseases such as active chronic hepatitis B,, decompensated cirrhosis, or active tuberculosis; (4) Patients with severe organ dysfunction affecting survival, such as malignant tumors or HIV infection; (5) Patients with severe primary diseases of the cardiovascular, hematological, neurological, digestive, or respiratory systems, or those with a significant tendency to bleed; (6) Patients with life-threatening conditions such as hyperkalemia or heart failure; (7) Patients with a GFR fluctuation of =30% within the past 3 months; (8) Patients with severe allergies to certain known drugs in this study or unable to tolerate them; (9) Patients who are pregnant or breastfeeding; (10) Patients with a history of drug abuse or who have used immunosuppressive agents or glucocorticoids in the past 3 months; (11) Patients with major bleeding or blood transfusion history in the past 3 months, or those with severe clinical infections or signs of acidosis; (12) Patients currently participating in other clinical trials or undergoing other Chinese herbal treatments that may affect efficacy assessment; (13) Patients planning or having undergone kidney transplantation, or those with acute or chronic kidney failure requiring immediate replacement therapy; (14) Patients with post-renal factors, such as obstruction (including stones, uric acid crystals, or tumors) causing acute kidney injury; (15) Patients with a history of mental illness or communication/cognitive impairments leading to poor compliance and inability to cooperate; (16) Non-Asian individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein quantification;Protein-to-creatinine ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Red blood cells in urine;Glomerular filtration rate;The number of infections in the respiratory, gastrointestinal, or urinary tract.;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactLu Keda
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed