IgA Nephropathy (IgAN)
Conditions
Brief summary
The goal of this clinical trial is to learn if Shenqi Yishen Granules works to treat IgA Nephropathy in adults. It will also learn about the safety of Shenqi Yishen Granules. The main questions it aims to answer are: Does Shenqi Yishen Granules lower 24-hour urinary protein quantification of participants? What medical problems do participants have when taking Shenqi Yishen Granules? Researchers will compare Shenqi Yishen Granules to a placebo (a look-alike substance that contains no drug) to see if Shenqi Yishen Granules works to treat IgA Nephropathy.
Interventions
DRUGShenqi Yishen Granules
A traditional Chinese medicine compound for the treatment of IgA nephropathy
DRUGPlacebo
a look-alike substance that contains no drug
Sponsors
Keda Lu
The First Affiliated Hospital of Zhejiang Chinese Medical University
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Red Cross Hospital, Hangzhou, China
Hangzhou Traditional Chinese Medicine Hospital
Zhenhai District Traditional Chinese Medicine Hospital
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Shao Yifu Hospital of Zhejiang Medical University
Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry
Yuyao City Traditional Chinese Medicine Hospital
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Affiliated Hospital of Jiaxing University
Hangzhou Xiaoshan First People's Hospital
Shanghai 6th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Meets the diagnostic criteria for IgA nephropathy and CKD stages 1-2, 24h-HPro \> 0.3g; 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
* (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 | Description |
|---|---|---|
| 24-hour urinary protein quantification | 0 weeks, 4 weeks, 8 weeks, 12 weeks | 24-hour urinary protein quantification |
| Protein-to-creatinine rati | 0 weeks, 4 weeks, 8 weeks, 12 weeks | Concentration of Protein-to-creatinine rati |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Red blood cells in urine | 0 weeks, 4 weeks, 8 weeks, 12 weeks | Red blood cells in urine |
| Glomerular filtration rate | 0 weeks, 4 weeks, 8 weeks, 12 weeks | Glomerular filtration rate |
| The number of infections in the respiratory, gastrointestinal, or urinary tract | 0 weeks, 4 weeks, 8 weeks, 12 weeks | The number of infections in the respiratory, gastrointestinal, or urinary tract |
| TCM syndrome score | 0 weeks, 4 weeks, 8 weeks, 12 weeks | Assess the patient's clinical symptoms based on the rating scale; the higher the score, the more severe the symptoms. |
Outcome results
None listed