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Retrospective study on the long-term efficacy and safety of Five-Flavor Sophora Flavescens enteric-coated capsules in the treatment of ulcerative colitis

Retrospective study on the long-term efficacy and safety of Wuwei Koushen enteric-coated capsule in the treatment of ulcerative colitis

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088375
Enrollment
Unknown
Registered
2024-08-16
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

UC(ulcerative colitis)

Interventions

Case series:NA

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who met the diagnosis of ulcerative colitis and took Five-Flavor Sophora Flavescens enteric-coated capsule since August 2018; 2.No age limit, no gender limit; 3.The treatment course of Five-Flavor Sophora Flavescens enteric-coated capsule was more than half a year; 4.In the process of patients using Five-Flavor Sophora Flavescens enteric coated capsules, the indicators of clinical efficacy that can be evaluated include: at least one clinical symptom evaluation every 3-6 months; Inflammatory markers (ESR, CRP/HsCRP) were evaluated at least once every 3 to 6 months; At least 1 colonoscopy evaluation every 6 months to 1 year. 5.In the process of using Five-Flavor Sophora Flavescens enteric-coated capsules, the indicators for safety evaluation include: at least 1-2 blood routine and liver and kidney function tests every six months, and at least 2-3 blood routine and liver and kidney function tests every year.

Exclusion criteria

Exclusion criteria: 1.discontinuous application of Five-Flavor Sophora Flavescens enteric capsules or combined use of Five-Flavor Sophora Flavescens enteric capsules dose does not meet the requirements; 2.Patients with two or more drugs for ulcerative colitis; 3.According to the judgment of the researcher, it is not appropriate to participate in this researcher.

Design outcomes

Primary

MeasureTime frame
fecal bleeding score;blood routine;biochemical indicators;Inflammatory indicators;colonoscopy;CAI score;Mayo score;number of stools;biochemical indicators;

Countries

China

Contacts

Public ContactHong Yang

Peking Union Medical College Hospital

hongy72@163.com+86 10 69155014

Outcome results

None listed

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