Evaluation and comparison of therapeutic results of acyclovir in the treatment and improvement of anal fissure in non-herpes simplex virus patients and control group
Evaluation of therapeutic results of acyclovir in the treatment and improvement of anal fissure in non-herpes simplex virus patients
Design
A clinical trial with the control group, with cross-groups, double-blind, randomized, phase 3 on 120 patients. To randomize the rand list version 2.00 will be used.
Settings and conduct
Patients will enter the study after obtaining informed consent and explaining the process of the study. A clinical examination will be performed every week to assess the healing of the fissure based on the numerical rating scale pain assessment system. The Short form-36 quality of life evaluation system will be used to evaluate. If healing is seen, the patient will be evaluated for relapse every month.
Participants/Inclusion and exclusion criteria
The present study is a clinical trialو in which the statistical population of the study is all patients referred to the clinic of Imam Reza Hospital. According to previous studies, the sample size is considered to be 120 people which will be selected via software.
Inclusion criteria included: patients with a clinical diagnosis of anal fissure, adults over 18 years of age, informed consent of patients to participate in the study, no previous history or current herpes simplex virus (HSV) infection, and other sexually transmitted diseases (STD).
Exclusion criteria include: having a previous or current history of HSV and other STDs involving the perianal area, patient dissatisfaction to participate in the study.
Intervention groups
Patients are divided into 2 groups of 60 people. A group of 60 people called the control group is given well-known anti-fisher drugs such as diltiazem.
The experimental group (including 60 people) will be given acyclovir ointment every 3 hours for 7 days.
Main outcome variables
Alterations in the severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200906048636N1
Registration date:2021-12-29, 1400/10/08
Registration timing:registered_while_recruiting
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Ali Farbod
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3554 0860
Email address
ali.frbd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of therapeutic results of acyclovir in the treatment and improvement of anal fissure in non-herpes simplex virus patients and control group
Public title
acyclovir in anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' informed consent to participate in the study
No previous or current history of HSV and other STDs
Adults over the age of 18
Referral patients with clinical diagnosis of anal fissure
Exclusion criteria:
Have a previous or current history of HSV and other perinatal STDs
Patient dissatisfaction to participate in the study
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Rand list version 1.2 Software
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are divided into 2 groups of 60 people. A group of 60 people called the control group is given known anti-fisher drugs such as diltiazem and the experimental group (including 60 people) will be used acyclovir ointment to treat anti-fissure.
Patients' clinical history will be reviewed by phone every day and every week in the clinic and all information will be recorded in the attached questionnaire.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.TBZMED.REC.1400.821
Health conditions studied
1
Description of health condition studied
Anal fissures
ICD-10 code
K60.2
ICD-10 code description
Anal fissure, unspecified
Primary outcomes
1
Description
Pain relief assessed based on numerical rating scale (NRS)
Timepoint
before intervention and 2, 3 , 4, 8, 12 weeks after intervention
Method of measurement
Checklist based on NRS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First group receiving acyclovir ointment as treatment of anal fissure
Category
Treatment - Drugs
2
Description
Control group: Second group receiving common treatment (diltiazem ointment) of the anal fissure
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hosital
Full name of responsible person
Ali Farbod
Street address
Imam Reza Hospital, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpour
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Farbod
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
0098413331317
Email
ali.frbd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Farbod
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 4334 1317
Email
Ali.frbd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Farbod
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Imam Reza Hospital, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
0098413331317
Email
ali.frbd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data including age, sex, history of STD (such as HSV), and the type of treatment used, will be shared anonymously.
When the data will become available and for how long
Data will be accessible 6 months following publication of the results
To whom data/document is available
Our documentations will be accessible for academic researchers.
Under which criteria data/document could be used
Any analysis of the data is approved.
From where data/document is obtainable
Ali Farbod
What processes are involved for a request to access data/document
The data will be accessible a maximum of 2 weeks after applying via email to Ali.frbd@gmail.com