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A Randomized Double-Blind Controlled Clinical Trial of Fushen Granules in Retarding Progression of Stage 3-4 Chronic Kidney Disease (Pi-Shen Qi Xu with Zhuo-Yu Nei Yun Syndrome)

A Randomized Double-Blind Controlled Clinical Trial of Fushen Granules in Retarding Progression of Stage 3-4 Chronic Kidney Disease (Pi-Shen Qi Xu with Zhuo-Yu Nei Yun Syndrome)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001670
Enrollment
Unknown
Registered
2025-09-04
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Stage 3-4 Chronic Kidney Disease

Interventions

Treatment Group:Conventional treatment + Fushen Granule
Control Group:Conventional treatment + 5% dosage of Fushen Granule

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years regardless of gender;(2) Primary disease is chronic glomerulonephritis;(3) Conforms to Western medical diagnostic and staging criteria as well as TCM syndrome differentiation criteria;(4) Infections blood pressure (=140/90 mmHg) etc. are effectively controlled;(5) Has signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with acute renal failure;(2) Patients with secondary kidney diseases such as diabetic kidney disease hypertensive nephropathy Henoch-Schönlein purpura nephritis lupus nephritis etc.;(3) Patients with severe primary diseases of heart brain lung liver hematopoietic system and immune system;(4) Patients known to be allergic to this type of drugs or multiple drugs;(5) Pregnant or planning to become pregnant and lactating women;(6) Patients with mental illnesses who are unable to cooperate;(7) Patients who have participated in other clinical trials within 3 months before enrollment;(8) Patients who have used glucocorticoids and immunosuppressants (including Tripterygium glycosides tablets) within 3 months before enrollment;(9) Patients after kidney transplantation or scheduled for renal replacement therapy;(10) Patients with severe digestive diseases affecting drug absorption such as active ulcers chronic diarrhea gastrointestinal surgery etc.;(11) Patients who are determined by the researchers not to be enrolled for other reasons.

Design outcomes

Primary

MeasureTime frame
Glomerular Filtration Rate;

Secondary

MeasureTime frame
Albumin;Quality of Life Score;High-Sensitivity C-Reactive Protein;Total Cholesterol;24-Hour Urine Protein Quantification;Blood Urea Nitrogen;Time to Endpoint Event and Incidence Rate;High-Density Lipoprotein;Traditional Chinese Medicine Syndrome Indicators;Fibrinogen;Triglycerides;Serum Uric Acid;Urine Albumin-to-Creatinine Ratio;Electrolytes;Total Protein;Low-Density Lipoprotein Cholesterol;Serum Creatinine;

Countries

China

Contacts

Public ContactBo Yang

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

yb8203@126.com18622662917

Outcome results

None listed

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