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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeda Lu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

(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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shenqi Yishen Granules

    Drug

    A traditional Chinese medicine compound for the treatment of IgA nephropathy

  • Placebo

    Drug

    a look-alike substance that contains no drug

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keda Lu

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Sponsor institution

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator

The Second Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator

Red Cross Hospital, Hangzhou, China

Collaborator

Hangzhou Traditional Chinese Medicine Hospital

Collaborator

Zhenhai District Traditional Chinese Medicine Hospital

Collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

Collaborator

Shao Yifu Hospital of Zhejiang Medical University

Collaborator

Hangzhou First People's Hospital, School of Medicine, Zhejiang Universiry

Collaborator

Yuyao City Traditional Chinese Medicine Hospital

Collaborator

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Collaborator

Affiliated Hospital of Jiaxing University

Collaborator

Hangzhou Xiaoshan First People's Hospital

Collaborator

Shanghai 6th People's Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: