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Clinical Study on the Effects of Fushen Granules on Quality of Life and Vsig4 Macrophages in Maintenance Peritoneal Dialysis Patients

Clinical Study on the Effects of Fushen Granules on Quality of Life and Vsig4 Macrophages in Maintenance Peritoneal Dialysis Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001664
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-09-08
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

Peritoneal dialysis

Interventions

Control group:The stable dialysis period is 12 to 16 weeks, and the conventional treatment lasts for 3 months
Fushen Granule Group:The stable dialysis period exceeded 12 to 16 weeks, with conventional treatment combined with oral administration of Fushen Granules for 3 months

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Informed Consent: Participants must provide signed informed consent and cooperate with the study procedures. 2. Age Requirement: Aged 18–80 years. 3. Diagnosis: Diagnosed with end-stage renal disease (ESRD) according to the 2012 KDIGO Clinical Practice Guidelines for CKD Evaluation and Management. 4. Dialysis Protocol: - Underwent peritoneal dialysis catheterization at our hospital. - Received regular follow-up at our peritoneal dialysis center. - Maintained stable peritoneal dialysis for 12–14 weeks. 5. Data Completeness: Participants must have complete clinical records and be able to undergo study-related statistical analysis. 6. Medication Restrictio: No use of **traditional Chinese medicine (TCM) or proprietary Chinese patent drugs within 2 weeks** prior to enrollment. 7. TCM Syndrome Pattern**: Classified as spleen-kidney qi deficiency syndrome.

Exclusion criteria

Exclusion criteria: 1. Unstable Medical Conditions: Patients with uncontrolled chronic diseases (e.g. severe cardiac cerebral hepatic or gastrointestinal disorders) malignancies hematologic diseases or active severe infections. 2. Concurrent Renal Replacement Therapy: Patients receiving hemodialysis or those who underwent hemodialysis plasmapheresis or hemofiltration within the past 12 weeks. 3. Cognitive/Behavioral Impairment: Patients with mental/psychological conditions that may compromise study compliance. 4. Peritoneal Dialysis-Associated Peritonitis: Active or recent episodes. 5. Pregnancy/Lactation: Women who are pregnant or breastfeeding. 6. Recent Medication Use: - Probiotics/microecological modulators antibiotics or immunosuppressants within 2 weeks. 7. Recent Abdominal Interventions: - Abdominal trauma gastrointestinal endoscopy or any surgery (other than peritoneal dialysis catheterization) within 12 weeks.

Design outcomes

Primary

MeasureTime frame
Kidney Disease Treatment Acceptance Scale Score;

Secondary

MeasureTime frame
36-Item Short Form Health Survey Score;

Countries

China

Contacts

Public ContactChen Jiang

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

jiangchen_doctor@163.com18622662919

Outcome results

None listed

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