The aim of this double blind clinical trial study is to compaire the effect of 0.5% Minoxidil cream with 2% Diltiazem cream on the patients suffering from chronic anal fissure coming to Imam khomeyni hospital,in Sari,in1393.patients suffering from Diabetes ,Hypertentsion ,cardiovascular disease and also those consuming Anti hypertensive drugs will be excluded .The total sample which includes110 patients,will be divided into two groups based on random-number table.The sampling will be undertaken over eight weeks.Each patient will be apply either Cream A OR B twice a day for two weeks.All of them will be reffer to the Office or Surgical clinic after one and also two months afterwards. Then they will be examine by the medical team for evaluating of Wound Healing , Bleeding,Pain , Itching and Dizziness.afterwards, the collected data including the effects of the two drugs on considered Variables will be located in corresponding columns to be compared later on.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041414483N6
Registration date:2015-05-12, 1394/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-12, 1394/02/22
Registrant information
Name
Mina Alvandipour
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1225 6329
Email address
malvandipour@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized double blind controlled clinical trial of Topical 0.5% minoxidil vs. 2% Diltiazem on chronic anal fissure
Public title
The Effect of Minoxidil cream on Anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All the patiens that are of 15 to 65 years old who had suffered from anal fissure and werent recovered after 6 weeks.
Exclusion criteria: Hypertensive patients; diabeties; vascular disease and heart failures; malignant patients; the patients with history of chemoterapy; the patients who taking ACEI or Diltiazem as a medication .
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Street address
Moallem Sq؛ Sari
City
Sari
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
13/12/1393
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
Anal Bleeding
Timepoint
Befor intervention- 1,2 mo After intervention
Method of measurement
History
2
Description
Wound Healing
Timepoint
Befor intervention- 1,2 mo After intervention
Method of measurement
Mucosal wound coverage
3
Description
Anal pain
Timepoint
Befor intervention-1,2mo After intervention
Method of measurement
VAS
Secondary outcomes
1
Description
Iitching
Timepoint
Befor intervention-1,2mo After intervention
Method of measurement
5-D pruritis scale
2
Description
Headache
Timepoint
Befor intervention-1,2 mo After intervention
Method of measurement
VAS
3
Description
Decrease in BP
Timepoint
Befor itervention-1,2 mo After intervention
Method of measurement
mm Hg
4
Description
Dizziness
Timepoint
Befor intervention-1,2 mo After intervention
Method of measurement
History
5
Description
Allergy
Timepoint
Befor intervention-1,2 mo After intervention
Method of measurement
History
Intervention groups
1
Description
Group 1:patients will be apply topical 2% Diltiazem cream twice a day for two weeks.
Category
Treatment - Drugs
2
Description
Group 2: patients will be apply 0.5% Minoxidil cream twice a day for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeyni hospital
Full name of responsible person
Dr.Mina Alvandipour
Street address
Amirmazandarani St, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Ahmadali Enayati
Street address
Moallem Sq, 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 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Mina Alvandipour
Position
staff colorectal surgeon
Other areas of specialty/work
Street address
Imam Khomeyni Hospital, Sari
City
Sari
Postal code
Phone
+98 11 3336 1700
Fax
Email
malvandipour@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Mehdi Khalvati
Position
Resident of surgery/student
Other areas of specialty/work
Street address
Imam Khomeyni Hospital, Amirmazandarani St, Sari
City
Sari
Postal code
Phone
+98 11 3326 3974
Fax
Email
khalvati_mehdi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)