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A randomised double-blind placebo-controlled clinical trial of the efficacy and safety of Yi Kidney and Turbidity Reducing Formula Granules in the treatment of chronic kidney disease (spleen and kidney qi deficiency syndrome)

A randomised double-blind placebo-controlled clinical trial of the efficacy and safety of Yi Kidney and Turbidity Reducing Formula Granules in the treatment of chronic kidney disease (spleen and kidney qi deficiency syndrome)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002452
Enrollment
Unknown
Registered
2025-12-22
Start date
2025-06-04
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney diseases

Interventions

treatment group:Yishen Jiangturbid Formula Granules 1 bag each time twice a day
control group:Yishen Jiangzhuo Formula Granules simulate placebo 1 bag each time twice a day

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for chronic kidney disease with the stage being 1 to 2; 2) It meets the syndrome criteria of spleen and kidney qi deficiency in traditional Chinese medicine; 3) Age: 18 to 75 years old (including endpoint values) gender not limited; 4) 24-hour urine protein quantification: 0.3-3.5g; 5) The research participants were informed and voluntarily signed the informed consent form

Exclusion criteria

Exclusion criteria: 1) Glycated hemoglobin =7.5%; 2) Hemoglobin (Hb) < 90g/L; 3) Serum creatinine (Scr) =1.5mg/dL (133µmol/L); 4) Blood pressure =180/110 MMHG; 5) Has used or currently requires hormone, immunosuppressant, or renal replacement therapy for treatment within 4 weeks, or has used traditional Chinese medicine for this disease; 6) Those with severe acute or chronic infections, as well as serious diseases of the heart, brain, liver, kidneys, hematopoietic system, etc., and those with mental illness, etc. 7) Pregnant women, women preparing for pregnancy or those who are breastfeeding; 8) There is a history of two or more drug or food allergies, with known or suspected allergies to the drug components of this test; Those who have participated in or are currently participating in other clinical trials within the past three months; 10) Those with a history of alcohol or drug abuse; 11) Those who, based on the researcher's judgment, have poor compliance, cannot follow the protocol or research procedures, and are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantity;

Secondary

MeasureTime frame
Changes in the staging of chronic kidney disease;TCM Syndrome scoring;24-hour urinary protein quantity;KDQOL-SF;eGFR;Effective drug withdrawal rate;

Countries

china

Contacts

Public ContactHaifeng Wang

China-Japan Friendship Hospital

bacq1114@163.com13426237086

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026