The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: IgA Nephropathy (IgAN)
• Intervention / Treatment: Drug: Shenqi Yishen Granules; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Shenqi Yishen Granules + Irbesartan	Drug: Shenqi Yishen Granules; A traditional Chinese medicine compound for the treatment of IgA nephropathy; Other Names: Irbesartan
Placebo Comparator: Control Group; Chinese herbal placebo + Irbesartan	Drug: Placebo; a look-alike substance that contains no drug; Other Names: Irbesartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour urinary protein quantification	24-hour urinary protein quantification	0 weeks, 4 weeks, 8 weeks, 12 weeks
Protein-to-creatinine rati	Concentration of Protein-to-creatinine rati	0 weeks, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red blood cells in urine	Red blood cells in urine	0 weeks, 4 weeks, 8 weeks, 12 weeks
Glomerular filtration rate	Glomerular filtration rate	0 weeks, 4 weeks, 8 weeks, 12 weeks
The number of infections in the respiratory, gastrointestinal, or urinary tract	The number of infections in the respiratory, gastrointestinal, or urinary tract	0 weeks, 4 weeks, 8 weeks, 12 weeks
TCM syndrome score	Assess the patient's clinical symptoms based on the rating scale; the higher the score, the more severe the symptoms.	0 weeks, 4 weeks, 8 weeks, 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of Potassium	Safety indicators	0 weeks, 4 weeks, 8 weeks, 12 weeks
electrocardiogram	Determine whether the patient has experienced adverse cardiac events based on the electrocardiogram	0 weeks, 4 weeks, 8 weeks, 12 weeks
Concentration of Alanine Aminotransferase	Safety indicators	0 weeks, 4 weeks, 8 weeks, 12 weeks
Concentration of Glutamic-oxaloacetic transaminase	Security indicators	0 weeks, 4 weeks, 8 weeks, 12 weeks
Concentration of hemoglobin	Security indicators	0 weeks, 4weeks, 8 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Keda Lu
• Collaborators: Red Cross Hospital, Hangzhou, China; Shanghai 6th People's Hospital; The First Affiliated Hospital of Zhejiang Chinese Medical University; Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry; Shao Yifu Hospital of Zhejiang Medical University; The Second Affiliated Hospital of Zhejiang Chinese Medical University; Hangzhou Traditional Chinese Medicine Hospital; Affiliated Hospital of Jiaxing University; First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine; Jiangsu Provincial Hospital of Traditional Chinese Medicine; Zhenhai District Traditional Chinese Medicine Hospital; Yuyao City Traditional Chinese Medicine Hospital; Hangzhou Xiaoshan First People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, IGA; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Polycyclic Compounds; Benzene Derivatives; Tetrazoles; Biphenyl Compounds; Spiro Compounds; Irbesartan
• Other Study ID Numbers: ZSLL-KY-2025-129-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data involves the personal privacy of participants and should not be made public or shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No