Radiation-induced Rectal Injury
Conditions
Interventions
Control group:Mesalazine enteric-coated tablets + metronidazole tablets + traditional Chinese medicine simulated placebo + gel matrix for external use
Chinese medicine treatment group:Heluoguchangfang granules for internal administration + compound ulcer gel for external use + mesalazine enteric-coated tablet simulator + metronidazole tablet simulat
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Meet the acute Radiation-induced Rectal Injury (RRI) diagnostic criteria of grade 2 or above as recognized by the Radiation Therapy Oncology Group (RTOG); after pelvic radiotherapy symptoms such as abdominal pain diarrhea hematochezia tenesmus mucopurulent bloody stools and anal pain occur; 2)Age between 18 and 75 years inclusive; 3)Eastern Cooperative Oncology Group (ECOG) performance status score = 2; 4)The subject is informed and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Individuals with a history of inflammatory bowel diseases such as proctitis ulcerative colitis and Crohn's disease; 2)Individuals with a history of diarrhea caused by internal diseases such as primary intestinal malabsorption hyperthyroidism etc.; 3)Individuals with comorbidities such as anal fissures anal incontinence and perianal infections; 4)Individuals who have had allergies to medications such as mesalazine metronidazole and traditional Chinese medicine ingredients in the formula of "He Luo Gu Chang Fang"; 5)Individuals who develop acute RRI requiring emergency surgery or endoscopic treatment (such as severe intestinal perforation intestinal fistulas etc.); 6)Women who are breastfeeding or pregnant; 7)Individuals who are unwilling to cooperate with this study or have any conditions that may interfere with the assessment of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of radiotherapy interruption;Life quality evaluation;Duration of Grade 3-4 Radiation-induced Rectal Injury;Incidence of grade 4 radiation rectal injury;Effective rate of TCM syndrome;Nutritional Risk Screening;Tumor control rate;numeric rating scales; | — |
Countries
China
Contacts
Public ContactQi Zhirong
China-Japan Friendship Hospital
Outcome results
None listed