A Randomized Controlled Trial of Five - Flavor Sophora Flavescens Enteric - Coated Capsules for Radiation - Induced Proctitis After Pelvic Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths, glutamine and warm - water sitz baths.
- Who it may be relevant to
- Registry conditions: Radiation - Induced Proctitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Clinical remission rate of acute radiation rectal injury [Time frame: 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07053761 · 2025-206