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

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special medicine called five-flavor sophora flavescens enteric-coated capsules can help people who develop radiation-induced proctitis, a condition where the lower part of the bowel becomes inflamed after receiving radiation treatment in the pelvic area. The study will compare patients who take these capsules to those who receive the usual treatments to see if the capsules improve symptoms and bowel health.

Adults between 18 and 80 years old who have had pelvic radiation and show signs of moderate bowel inflammation (measured by tests like stool bleeding or inflammation markers) may be eligible to join. People with certain health problems, such as serious heart issues, other bowel diseases, or allergies to the capsule ingredients, cannot participate. Those who join will be randomly assigned to take either the capsules or standard therapy and will be closely monitored through tests and follow-up visits to track their progress. This study is not yet recruiting participants but aims to find a new treatment option for those affected by radiation-related bowel problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 - 80 years. Undergoing pelvic radiotherapy with RTOG radiation - toxicity grade ≥2 and FOB (+) or fecal calprotectin Fc\>150μg/g.
• • Absolute neutrophil count \>1,500/μL, platelets \>100,000/μL; AST \<45U/L, ALT \<40U/L; creatinine clearance \>50ml/min.
• • Willing to sign consent and participate in required tests and follow - up.
• Exclusion Criteria:
• • Previous pelvic/abdominal radiotherapy. Other severe intestinal diseases (e.g., Crohn's, ulcerative colitis, colorectal cancer).
• • Contraindications to five - flavor sophora flavescens enteric - coated capsules (e.g., prolonged QTc, hypokalemia, use of QTc - prolonging drugs, heart disease).
• • Allergy to the capsules or their components. Other therapies for radiation - induced proctitis (e.g., mesalamine, steroids, hyperbaric oxygen, laser therapy) in the past month.
• • Uncontrolled diseases that may affect the study, such as organ dysfunction, poorly controlled hypertension, coronary heart disease, arrhythmias, cerebrovascular disease, diabetes; myocardial infarction or heart failure in the past 6 months; jaundice due to hepatic insufficiency; AIDS; uncontrolled coagulation disorders.
• • Psychiatric patients unable to complete the study.