The effects of aloe vera ointment in proctitis induced by radiotherapy
Phase 2
- Conditions
- Acute Radiation Proctitis.Radiation proctitis
- Registration Number
- IRCT201606042027N6
- Lead Sponsor
- Mazandaran University of Medical Scienses
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Inclusion Criteria: patients aged older than 18 years; patients with a history of pelvic radiation.
Exclusion Criteria
Evidence of active infection; evidence of other sources of hematochezia including colon cancer, inflammatory bowel disease, and hemorrhoids; anal incontinence; anorectal fistula; anorectal stenosis; previous rectal surgery; pregnancy or breast feeding; female of child-bearing age not taking adequate contraception; known allergy to any ingredients of the ointments; concomitant use of antibiotics or steroids.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Developement of proctitis. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on clinical presentation.;Proctitis severity. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on Radiation Therapy Oncology Group (RTOG) criteria.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on questionnaire.;Quantitative CRP. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on patient's blood sample.;Social-Psychological state. Timepoint: before intervention, then weekly for six weeks after intervention. Method of measurement: based on Hospital Anxiety-Deprresion (HAD) scale.