Radiation - Induced ProctitisPhase 2NCT07053761
A Randomized Controlled Trial of Five - Flavor Sophora Flavescens Enteric - Coated Capsules for Radiation - Induced Proctitis After Pelvic Radiotherapy
A Phase 2 study testing five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths and glutamine and warm - water sitz baths in people with Radiation - Induced Proctitis, run by Peking University First Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation - Induced Proctitis
- What is being tested?
- five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths and glutamine and warm - water sitz baths
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Radiation - Induced Proctitis
- Being tested
- five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths, glutamine and warm - water sitz baths
- Keywords
- radiation - induced proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz bathsDrug
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 bathsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths |
| control group | Active comparator | Not described Receives: Drug: glutamine and warm - water sitz baths |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate of acute radiation rectal injury
Clinical remission rate of acute radiation rectal injury
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation - Induced ProctitisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shangbin QIN, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053761
- Sponsor's protocol ID
- 2025-206
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Five - Flavor Sophora Flavescens Enteric - Coated Capsules for Radiation - Induced Proctitis After Pelvic Radiotherapy
- ClinicalTrials.gov ID
- NCT07053761
- Acronym / sponsor ID
- 2025-206
- Conditions
- Radiation - Induced Proctitis
- Keywords
- radiation - induced proctitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths |
| control group | Active comparator | Drug: glutamine and warm - water sitz baths |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz bathsExperimental 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 | Experimental group |
| glutamine and warm - water sitz bathsIf 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. | Drug | control group |
Primary outcome
Clinical remission rate of acute radiation rectal injury
Time frame: 3 months
Clinical remission rate of acute radiation rectal injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Related trials for Radiation - Induced Proctitis
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
Not yet recruitingPhase 3
A Study of Chlorophyllin or Placebo With Standard Treatment for Late Radiation Induced Luminal Gastrointestinal Tract Bleeding
Radiation Proctitis, Gastrointestinal Hemorrhage
RecruitingObservational study
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
Pelvic Toxicity, Radiation Toxicity
RecruitingObservational study
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
Radiotherapy, Radiation Proctitis
RecruitingPhase 2
Dietary Supplements to Treat Radiation-Induced Rectal Injury
Radiotherapy, Radiation Proctitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing five - flavor sophora flavescens enteric - coated capsules plus glutamine and warm - water sitz baths and glutamine and warm - water sitz baths in people with Radiation - Induced Proctitis, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate of acute radiation rectal injury (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.