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Not yet recruitingNCT07360002Updated Jan 22, 2026

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

An interventional study of Shenqi Yishen Granules and Placebo in IgA Nephropathy (IgAN), sponsored by Keda Lu. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Keda Lu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • IgA Nephropathy (IgAN)
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In context

Glomerulonephritis, IGA

254 studies on the registry are indexed under Glomerulonephritis, IGA; 100 are open to participants now.

This study's planned enrollment of 102 is above the median of 70 across 206 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

This is the only study on the registry with Keda Lu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Treatment group

    Shenqi Yishen Granules + Irbesartan

    Drug: Shenqi Yishen Granules

  • Placebo comparator
    Control Group

    Chinese herbal placebo + Irbesartan

    Drug: Placebo

Interventions

  • DrugShenqi Yishen Granules

    A traditional Chinese medicine compound for the treatment of IgA nephropathy

    Also known as: Irbesartan

  • DrugPlacebo

    a look-alike substance that contains no drug

    Also known as: Irbesartan

06

What researchers measure

Primary outcomes

  1. 24-hour urinary protein quantification

    24-hour urinary protein quantification

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

  2. Protein-to-creatinine rati

    Concentration of Protein-to-creatinine rati

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

Secondary outcomes

  1. Red blood cells in urine

    Red blood cells in urine

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

  2. Glomerular filtration rate

    Glomerular filtration rate

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

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

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

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

  4. TCM syndrome score

    Assess the patient's clinical symptoms based on the rating scale; the higher the score, the more severe the symptoms.

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

Other outcomes

  1. Concentration of Potassium

    Safety indicators

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

  2. electrocardiogram

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

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

  3. Concentration of Alanine Aminotransferase

    Safety indicators

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

  4. Concentration of Glutamic-oxaloacetic transaminase

    Security indicators

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

  5. Concentration of hemoglobin

    Security indicators

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

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data involves the personal privacy of participants and should not be made public or shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07360002
Lead sponsor
Keda Lu
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Red Cross Hospital, Hangzhou, China, Hangzhou Hospital of Traditional Chinese Medicine, Zhenhai District Traditional Chinese Medicine Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Shao Yifu Hospital of Zhejiang Medical University, Zhejiang University, Yuyao City Traditional Chinese Medicine Hospital, The 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
Responsible party
Keda Lu (Professor, The Third Affiliated hospital of Zhejiang Chinese Medical University) — Sponsor-investigator
First posted
Jan 22, 2026
Start date
Jan 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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