Radiation Proctitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients with radiation proctitis after radiotherapy for pelvic malignant tumors (including cervical cancer endometrial cancer rectal cancer prostate cancer pelvic bone metastases multiple myeloma etc.); (2) Meets the diagnostic criteria of Western medicine and has clinical manifestations. One item in colonoscopy one item in barium enema or histopathological examination can diagnose this patient. (3) Those who meet the diagnosis criteria of intestinal damp heat syndrome in traditional Chinese medicine; (4) Patients who can tolerate enema treatment; (5) Age above 18 years old and below 75 years old (including boundary values) regardless of gender or ethnicity; (6) Expected survival period = 3 months; (7) Those who voluntarily participate in clinical trials and sign informed consent forms.
Exclusion criteria
Exclusion criteria: (1) Patients with serious complications such as heavy bleeding intestinal obstruction and intestinal perforation; (2) Pregnant or preparing pregnant women; (3) Individuals with allergies or allergies to multiple medications; (4) Patients with severe primary diseases such as liver kidney hematopoietic system endocrine system and psychiatric disorders; (5) The patient's condition is critical and it is difficult to make a precise evaluation of the effectiveness and safety of the medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 16S rRNA;Metabolomics testing;RTOG/EORTC(European Organisation for Research and Treatment of Cancer-Radiation Therapy Oncology Group); | — |
Secondary
| Measure | Time frame |
|---|---|
| ECOG (Eastern Cooperative Oncology Group) Performance Status;Pathological Assessment;Imaging assessment;Serum Inflammatory Markers;Vienna Rectoscopy Score; | — |
Countries
China
Contacts
Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University