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NCT Number: NCT07360002

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets the diagnostic criteria for IgA nephropathy and CKD stages 1-2, 24h-HPro > 0.3g;
  • Meets the diagnostic criteria for "qi and yin deficiency syndrome" according to Traditional Chinese Medicine;
  • Age between 18 and 75 years, gender;
  • Infection, acidosis, electrolyte imbalance, hypertension, etc., are well controlled;
  • No failure of other organ functions;
  • 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.

Treatment and study plan

Shenqi Yishen Granules

Drug

A traditional Chinese medicine compound for the treatment of IgA nephropathy

Other names: Irbesartan

Placebo

Drug

a look-alike substance that contains no drug

Other names: Irbesartan

Primary outcomes

  1. 24-hour urinary protein quantification

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    24-hour urinary protein quantification

  2. Protein-to-creatinine rati

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    Concentration of Protein-to-creatinine rati

Secondary outcomes

  1. Red blood cells in urine

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    Red blood cells in urine

  2. Glomerular filtration rate

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    Glomerular filtration rate

  3. The number of infections in the respiratory, gastrointestinal, or urinary tract

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    The number of infections in the respiratory, gastrointestinal, or urinary tract

  4. TCM syndrome score

    Time frame: 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.

Other outcomes

  1. Concentration of Potassium

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    Safety indicators

  2. electrocardiogram

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    Determine whether the patient has experienced adverse cardiac events based on the electrocardiogram

  3. Concentration of Alanine Aminotransferase

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    Safety indicators

  4. Concentration of Glutamic-oxaloacetic transaminase

    Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

    Security indicators

  5. Concentration of hemoglobin

    Time frame: 0 weeks, 4weeks, 8 weeks, 12 weeks

    Security indicators

Sponsors and collaborators

Lead sponsor

Keda Lu

Other

Collaborators

  • Affiliated Hospital of Jiaxing University
  • Hangzhou Traditional Chinese Medicine Hospital
  • Hangzhou Xiaoshan First People's Hospital
  • Jiangsu Province Hospital of Traditional Chinese Medicine
  • Red Cross Hospital, Hangzhou, China
  • Shanghai 6th People's Hospital
  • Shao Yifu Hospital of Zhejiang Medical University
  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Zhejiang Chinese Medical University
  • The Second Affiliated Hospital of Zhejiang Chinese Medical University
  • Yuyao City Traditional Chinese Medicine Hospital
  • Zhejiang University
  • Zhenhai District Traditional Chinese Medicine Hospital

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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