Effect of topical application of Nitroglycerin plus Diltiazem compared with the two methods of topical use of Bethanechol and Diltiazem in the treatment of patients with chronic anal fissure
Objectives: Main objective: Comparison of the three types of medical treatment; Topical application of Nitroglycerin plus Diltiazem Gel , Bethanechol Gel and Diltiazem Gel in healing chronic anal fissure Secondary objectives: Record and assessment of pain and bleeding before, 4 and 8 weeks after treatment with the mentioned drugs Design: 90 patients with chronic anal fissure will be randomly divided into 3 groups: Group A: The recipient of combined therapy (1% Nitroglycerin cream plus 5% Diltiazem Gel as two separate products), Group B: Recipient of 5% Diltiazem Gel and Group C Receive 0.01% bethanechol Gel.Setting and conduct: The mentioned drugs will be taken topically three times a day for 8 weeks. After four and eight weeks patients will be examined for the condition of the healing, pain and bleeding. Inclusion and Exclusion criteria: Inclusion criteria: for this study does not consider specific criteria except having acute fissures. Exclusion criteria: pregnancy; Inflammatory bowel disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110130623N1
Registration date:2017-09-13, 1396/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-13, 1396/06/22
Registrant information
Name
Baran Parhizkar
Name of organization / entity
Kurdistan University of Medical scinces
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 4414
Email address
b.parhizkar@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Kurdistan University of Medical Sciences
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical application of Nitroglycerin plus Diltiazem compared with the two methods of topical use of Bethanechol and Diltiazem in the treatment of patients with chronic anal fissure
Public title
Comparison of the three types of medical treatment; Topical application of Nitroglycerin plus Diltiazem Gel , Bethanechol Gel and Diltiazem Gel in healing chronic anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: for this study does not consider specific criteria except having acute fissures.
Exclusion Criteria: pregnancy; Inflammatory bowel disease; The incidence of side effects; Leave treatment; Colon cancer
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A total of 90 patients were randomly divided into three groups of 30 subjects by blocking method. In order to blind the study, the drugs were given to patients by a nurse who was not sensitive to the results of the study. All of the patients' codes were kept by him until the data analysis phase, and the project executives were unaware of them until the end of the study Patients' visits were also carried out by a gastroenterologist who was not aware of the groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan university of medical sciences
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
sanandaj
Postal code
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
MUK.REC.1394.142
Health conditions studied
1
Description of health condition studied
chronic anal fissure
ICD-10 code
0,K60.1
ICD-10 code description
chronic anal fissure
Primary outcomes
1
Description
healing of fissure
Timepoint
Before intervention , 4 and 8 weeks after intervention
Method of measurement
Examination
Secondary outcomes
1
Description
bleeding
Timepoint
Before intervention, 4 and 8 weeks after intervention
Method of measurement
Examination and question from the patient
2
Description
Pain
Timepoint
Before intervention , 4 and 8 weeks after intervention
Method of measurement
Examination and question from the patient
Intervention groups
1
Description
Interventional group 1: Combination therapy (1% Nitroglycerine ointment plus topical 5% Diltiazem gel as separate product), TDS for eight weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: bethanechol , 0.1% gel, topical, TDS for eight weeks
Category
Treatment - Drugs
3
Description
Control group: diltiazem, 5% gel, topical, TDS for eight weeks