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Clinical study of Fushen Formula intervention of intestinal flora and metabolites in peritoneal dialysis-associated peritonitis to improve abdominal immune function

Clinical study of Fushen Formula intervention of intestinal flora and metabolites in peritoneal dialysis-associated peritonitis to improve abdominal immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073605
Enrollment
Unknown
Registered
2023-07-17
Start date
2023-07-20
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

peritoneal dialysis-related peritonitis

Interventions

Western medicine group:According to the 2022 ISPD guidelines, the empirical antibiotic regimen covered gram-positive and gram-negative bacteria, and cefazolin sodium and cefoperazone sodium and sulbac
Fushen Formula group:On the basis of the treatment plan of the western medicine group, Fushen formula (10g Tangerine peel, 15g Qingpinellia, 15g Epimedium, 30g salvia miltiorrhiza, 10g angelica, 15g a

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. Subjects sign informed consent and cooperate with the study; 2. Subjects aged 18-80 years; 3. Patients with end-stage renal disease were diagnosed according to Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline; 4. Subjects undergoing dialysis catheterization in our hospital were regularly followed up at our peritoneal dialysis center to maintain stable peritoneal dialysis; 5. Subjects with complete clinical data and able to complete relevant statistical analysis of this study; 6. No Chinese medicine or proprietary medicine taken within 2 weeks; 7. Meeting the diagnostic criteria for peritoneal dialysis-associated peritonitis; 8. The syndrome type of TCM is spleen and kidney qi deficiency.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the inclusion criteria; 2. Patients with unstable conditions, complicated with serious chronic diseases of the heart, brain, liver, gastrointestinal tract, tumors, blood diseases and severe infectious diseases; 3. Patients undergoing hemodialysis at the same time or undergoing hemodialysis, plasmapheresis or hemofiltration within 3 months; 4. Patients whose mental state cannot cooperate with observation; 5. Patients with acute renal failure; 6. According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion; 7. Refractory peritonitis, fungal/tuberculous peritonitis, etc.; 8. Pregnant or lactating women; 9. Patients who have taken probiotics and other microecological regulators, antibiotics and immunosuppressants in the past two weeks; 10. Patients with a history of abdominal trauma, gastrointestinal endoscopy or surgery in the last 3 months.

Design outcomes

Primary

MeasureTime frame
TCM clinical syndrome scoring scale;

Secondary

MeasureTime frame
liver function;renal function;blood fat;eritoneal dialysate cell detection;peritoneum resident macrophages;Intestinal microflora communities and metabolites of intestinal microflora;Peritoneal dialysate inflammatory factors;blood routine examination;Serum electrolytes;

Countries

the People's Republic of China

Contacts

Public ContactChen Jiang

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

tjtcmjc@163.com+86 186 2266 2979

Outcome results

None listed

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