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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

Protocol summary

Summary
This study is a prospective phase 2, double-blinded randomized, placebo controlled, single center clinical trial conducted at Radiotherapy Center of Imam Khomeini Hospital in Sari, Mazandaran province, Iran. If the patients aged older than 18 years and received pelvic radiation, they’d enter in the study. The patients will be randomized into two groups based on the table of random numbers, including 30 in each group. In this study, the effectiveness of aloe vera in prevention and treatment of acute radiation-proctitis is evaluated. The eligible patients are randomized as follow: topical ointment of aloe vera 3% BID or placebo ointment. If the patients troubled with acute proctitis symptoms during study, they will enter the second phase of study; they are randomized into one of the following groups: aloe vera ointment BID plus tablet sulfasalazine 500mg QID or placebo ointment BID plus tablet sulfasalazine 500mg QID. The patients are followed up weekly for 6 weeks and if they experience proctitis, therapy with aloe vera will be continued for 4 weeks more. The primary end points are proctitis development based on clinical presentation, the severity of proctitis based on Radiation therapy oncology group (RTOG) criteria and the second outcomes will be quality of life, quantitative CRP and social-psychological state based on Hospital Anxiety-Depression (HAD) scale .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606042027N6
Registration date: 2016-09-04, 1395/06/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-05-30, 1395/03/10
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effects of aloe vera ointment in proctitis induced by radiotherapy
Purpose
Prevention
Inclusion/Exclusion 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.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square
City
Sari
Postal code
861-48175
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
IR.MAZUMS.REC.94-1196

Health conditions studied

1

Description of health condition studied
Acute Radiation Proctitis
ICD-10 code
62.7
ICD-10 code description
Radiation proctitis

Primary outcomes

1

Description
Developement of proctitis
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on clinical presentation

2

Description
proctitis severity
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on Radiation Therapy Oncology Group (RTOG) criteria

Secondary outcomes

1

Description
Quality of life
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on questionnaire

2

Description
Quantitative CRP
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on patient's blood sample

3

Description
Social-Psychological state
Timepoint
before intervention, then weekly for six weeks after intervention
Method of measurement
based on Hospital Anxiety-Deprresion (HAD) scale

Intervention groups

1

Description
Intervention group: aloe vera ointment 1 g twice daily from the first day of study for six weeks
Category
Treatment - Drugs

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Radiotherapy Center of Imam Khomeini Hospital
Full name of responsible person
Adeleh Sahebnasagh
Street address
Radiotherapy Center of Imam Khomeini Hospital, Sari, Mazandaran Province, Iran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Scienses
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research of Mazandaran University of Medical Sciences, Moallem Square, Sari
City
Sari
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Scienses
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Faculty member, Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Faculty member, Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
ّFaculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Faculty member, Professor of Clinical Pharmacy
Other areas of specialty/work
Street address
Faculty of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Sari
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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