The aim of this Clinical Trial study is to evaluate the effect of Aloe Vera cream on treatment of chronic anal fissures. Thirty patients with chronic anal fissure will be enrolled in this study. The exclusion criteria are other anorectal diseases, addiction, alcohol usage, pregnancy and hypersensitivity to Aloe Vera products. Patients are 20-70 years old with chronic anal fissure. Patients will receive Aloe Vera cream in specific tube and be educated that consume 3 gr of this cram three times daily for 3 weeks. Patient will be visited every week for 3 weeks. Reducing in pain, bleeding and wound inflammation are outcomes of this intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801151786N1
Registration date:2009-06-24, 1388/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-24, 1388/04/03
Registrant information
Name
Nasrin Rahmani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
nrahmani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and health services
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2009-01-20, 1387/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Aloe Vera on treatment of chronic anal fissure
Public title
Efficacy of Aloe Vera on treatment of chronic anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients 20-70 years old with chronic anal fissure
Exclusion criteria: other anorectal diseases, addiction, alcohol usage, pregnancy and hypersensitivity to aloe Vera products
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway
City
Sari
Postal code
Approval date
2009-05-01, 1388/02/11
Ethics committee reference number
120-87
Health conditions studied
1
Description of health condition studied
chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
pain after defication
Timepoint
1.2.3.4.5.6 weeks after treatment
Method of measurement
VAS
2
Description
bleeding
Timepoint
1.2.3.4.5.6 weeks after treatment
Method of measurement
question
Secondary outcomes
1
Description
wound healing
Timepoint
1,2,3,4,5,6 weeks after treatment
Method of measurement
obsevation
Intervention groups
1
Description
Aloe Vera cream 3 gr, three times daily for 3 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iimam khomaini hospital
Full name of responsible person
Nasrin Rahmani
Street address
Razi street- Imam khomani hospital-general surjery department
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sayed Jalal Hosseini mehr
Street address
Moalem sq.
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 Sciences
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
Mazandaran Univercity of medical sciences and Health services