During this project the patients who come to Bushehr Abolfazl clinic with acute anal fissure symptoms are examined by a general surgeon and they will randomly be divided to two groups if the diagnosis is definitely acute anal fissure. One group (20 cases) will take Colofac and the other group (20 cases) will take routine medicines. Then the patients will be followed up in order to evaluate the effect of the medicine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009294840N1
Registration date:2011-02-01, 1389/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-01, 1389/11/12
Registrant information
Name
Hamid Reza Alizadeh
Name of organization / entity
Bushehr University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1252 4044
Email address
hr.alizadeh@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Bushehr University Of Medical Sciences
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of Colofac efficacy in treatment of acute anal fissure
Public title
The evaluation of Colofac efficacy in treatment of anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis is definitely acute anal fissure, age between 15-65 yr. Exclusion criteria: existence of underlying diseases such as cancer (carcinoma, leukemia), IBD, TB, AIDS, STD and syphilis.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University Of Medical Sciences
Street address
Moallem street
City
Bushehr
Postal code
Approval date
1990-01-01, 1368/10/11
Ethics committee reference number
2320
Health conditions studied
1
Description of health condition studied
Acute Anal Fissure
ICD-10 code
K60.0
ICD-10 code description
Acute anal fissure
Primary outcomes
1
Description
Improvement of ulcer
Timepoint
2 weeks
Method of measurement
Physical Exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 135 mg of Colofac every night till treatment of ulcer
Category
Treatment - Drugs
2
Description
Control group: routine methods of anal fissure treatment
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Abolfazl Clinic
Full name of responsible person
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Bushehr University Of Medical Sciences
Full name of responsible person
Dr Abdollatif Amini
Street address
Bushehr University Of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Bushehr 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
Bushehr University Of Medical Sciences
Full name of responsible person
Raheleh Abolfathi Momtaz
Position
Student Of Medicine
Other areas of specialty/work
Street address
Sadaf Dormitory, Bushehr Baghezahra Street
City
Bushehr
Postal code
Phone
+98 917 173 5938
Fax
Email
raha_1213@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University Of Medical Sciences
Full name of responsible person
Dr Hamidreza Alizadeh
Position
Surgery Specialist
Other areas of specialty/work
Street address
Fatemeh Zahra Hospital
City
Bushehr
Postal code
Phone
+98 912 289 0428
Fax
Email
drhralizade@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University Of Medical Sciences
Full name of responsible person
Raheleh Abolfathi Momtaz
Position
Student Of Medicine
Other areas of specialty/work
Street address
Sadaf dormitory, Bagh Zahra Street
City
Bushehr
Postal code
Phone
+98 917 173 5938
Fax
Email
raha_1213@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)