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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Radiation - Induced Proctitis
Interventions
DRUG

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.

DRUG

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.

All Listed Sponsors
lead

Peking University First Hospital

OTHER