Anal fissure is a common disease which manifest by pain and rectal bleeding associated with bowel movement . The aim of the present study is to Comparison the effects of 0.5% captopril cream with 2% diltiazem cream in reduction of pain after defecation .Type of study:A prospective, double-blind, randomized,without placebo controled trial . inclusion criteria :Patients who had chronic anal fissure between 18-65 years old .
Exclusion criteria:Individuals who show hyper sensivity to the product and the patients with hypertension using ACEI and those with increased ulcer size after using the product . intervention 1 : 0.5 % captopril cream twice daily for 2 months . intervention 2 : 2 % diltiazem cream twice daily for 2 months . outcomes : (1) pain. methods of measurement: visual analogue Scale ,
2 - itching Method D-5
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308043014N7
Registration date:2014-10-12, 1393/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-12, 1393/07/20
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2014-09-19, 1393/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of 0.5% captopril cream with 2% diltiazem cream on chronic anal fissure
Public title
Effects of 0.5% captopril cream with 2% diltiazem cream on chronic anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who had anal fissure ؛ between 18-65 years old
exclusion criteria :Individuals who show hypersensivity to the product ؛ the patients with hypertension using ACEI ؛ and those with increased ulcer size after using the product
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences, Ethical Commitee
Street address
Vice chancellor of research , Moalem square
City
Sari
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
2154
Health conditions studied
1
Description of health condition studied
Anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
Pain
Timepoint
Each weeks for 2 weeks then each month for 2 month
Method of measurement
Visual analog
Secondary outcomes
1
Description
Iitching
Timepoint
Each month till 2 month
Method of measurement
5D
Intervention groups
1
Description
Captopril 2% cream ,BID FOR 2 Weeks for 1 cm
Category
Treatment - Drugs
2
Description
intervention 1 : Cream 0.5 % captopril BID for 2weeks.each dose 1 cm
Category
Treatment - Drugs
3
Description
intervention 2 : Diltiazem 2 % cream BID for 2 weeks each dose 1 cm
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooba special clinic
Full name of responsible person
Roja Qobadi Ghadikolaei
Street address
Tooba special clinic, Khazar street, Sari, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Doctor Ahmad Enayati
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research and technology, Moallem square, Sari, Mazandaran, Iran
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, Vice chancellor for research
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 University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Roja Qobadi Ghadikolaei
Position
Pharmacy student
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 15 1311 0267
Fax
Email
roja.ghobadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinical pharmacy specialist,Faculty of pharmacy, Sari
Full name of responsible person
Dr Shahram Ala
Position
Associated professor of clinical pharmacy
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
sh204ala@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran university of medical sience
Full name of responsible person
Dr Shahram Ala
Position
Associated professor of clinical pharmacy
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 15 1354 3083
Fax
Email
sh204ala@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)