Clinical Trial

A Randomized Controlled Trial of Five - Flavor Sophora Flavescens Enteric - Coated Capsules for Radiation - Induced Proctitis After Pelvic Radiotherapy

Not Yet Recruiting Phase 2
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Record status
This record was last updated July 8, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this single - center, prospective, randomized controlled study is to assess the therapeutic effects of five - flavor sophora flavescens enteric - coated capsules on radiation - induced proctitis in patients who have undergone pelvic radiotherapy. The main question it aims to answer is: Does five - flavor sophora flavescens enteric - coated capsules treatment improve radiation - induced proctitis in these patients? Participants with radiation - induced proctitis following pelvic radiotherapy will be randomly allocated to either the trial group (receiving the capsules) or the control group (receiving conventional therapy). Assessments will be conducted to compare outcomes between the two groups.
Trial Details
NCT Number NCT07053761
Lead Sponsor Peking University First Hospital
Conditions Radiation - Induced Proctitis
Enrollment 124 participants
Start Date 2025-06-30
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-08