The effects of aloe vera ointment in proctitis induced by radiotherapy

A comparison between the effects of aloe vera ointment versus placebo in prevention and treatment ofacute proctitis induced by radiotherapy: a randomized controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201606042027N6

Enrollment

Registered

2016-09-04

Start date

2016-05-30

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Acute Radiation Proctitis. Radiation proctitis

Interventions

Control group: placebo ointment 1 g twice daily from the first day of study for six weeks

Intervention 1: Intervention group: aloe vera ointment 1 g twice daily from the first day of study for six weeks. Intervention 2: Control group: placebo ointment 1 g twice daily from the first day of

Treatment - Drugs

Placebo

Intervention group: aloe vera ointment 1 g twice daily from the first day of study for six weeks

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEbrahim Salehifar

Faculty of Pharmacy, Mazandaran University of Medical Sciences

Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com+98 11 3354 3082

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 18, 2026