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A Randomized Controlled Trial of Five - Flavor Sophora Flavescens Enteric - Coated Capsules for Radiation - Induced Proctitis After Pelvic Radiotherapy
Sponsor: Peking University First Hospital
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2025-06-30
Completion Date
2026-06-30
Last Updated
2025-07-08
Healthy Volunteers
No
Conditions
Interventions
five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths
Experimental group: If patients have rectal reactions, RTOG radiation - therapy toxicity grades \>2, plus FOB (+) or fecal calprotectin Fc\>150μg/g, they'll take five - flavor sophora flavescens enteric - coated capsules (4 capsules thrice daily for 8 weeks), plus glutamine and warm - water sitz baths.
glutamine and warm - water sitz baths
If patients have rectal reactions, RTOG radiation - therapy toxicity grades \>2, plus FOB (+) or fecal calprotectin Fc\>150μg/g, they'll use only glutamine and warm - water sitz baths.