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A two-way cohort of Chinese medicine to prevent RRI and a single-group target value study of clearing heat and thick bowel method

A two-way cohort of Chinese medicine to prevent RRI and a single-group target value study of clearing heat and thick bowel method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001704
Enrollment
Unknown
Registered
2025-09-11
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

radiation proctitis

Interventions

experimental group:Gegen Qinlian Decoction for each 100 mL oral dose twice daily.

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Bidirectional Cohort. (1) Patients aged 18 years or older (inclusive); (2) Patients were pathologically diagnosed with pelvic malignant tumors; (3) Received radiation therapy; (4) No history of abdominal or pelvic radiotherapy; (5) Pelvic MRI imaging within 2 weeks before radiotherapy and MRI imaging (outpatient or remote) consultation at 1 3 and 6 months after radiotherapy; (6) Agreed to enroll in the study and signed an informed consent form. Intervention cohort: (1) Patients were 18 years of age or older (including 18); (2) Patients were pathologically diagnosed with pelvic malignant tumors; (3) Received radical pelvic radiation therapy; (4) No history of abdominal or pelvic radiotherapy; (5) Received pelvic MRI imaging within 1 week before radiotherapy; (6) Agreed to enroll in this study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: Bidirectional cohort: (1) Radiotherapy interrupted for 5 days or more for various reasons; (2) Patients undergoing surgery within 6 months of radiotherapy; (3) Presence of a second primary tumor; (4) Incomplete radiotherapy data including localization CT and dose documentation; inability to identify RRI during or after radiotherapy. Prospective intervention cohort (1) Presence of a second primary tumor; (2) Those with prior bowel-related diseases such as proctitis ulcerative colitis and Crohn's disease; (3) Prior diarrhea due to medical conditions such as primary small bowel malabsorption and hyperthyroidism; (4) Combination of anal fissure anal incontinence and perianal infection; (5) Lactating or pregnant women.

Design outcomes

Primary

MeasureTime frame
Chinese Medicine Symptom Grading;Radiation Therapy Oncology Group (RTOG) grading;

Countries

China

Contacts

Public ContactQinglin Li

Zhejiang Cancer Hospital

qinglin200886@126.com+86 158 6811 8910

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026