Comparison of the efficacy of Barriage Antifischer cream and Diltiazem gel in reducing the severity of anal fissures and their complications.
Design
Randomization will be conducted using a block method with blocks of four, considering Group A as receivers of Antifischer cream and Group B as receivers of Diltiazem gel. A total of 80 participants will be enrolled in Phases 1-2 of this trial. The study will be double-blind, and the Python randint function will be used for randomization.
Settings and conduct
The study will be conducted at the surgical clinic of Shahid Beheshti Hospital in Kashan. The trial will employ a double-blind approach, where both the clinical evaluators and the patients are blinded to the groups. This is achieved by providing the gel or cream in colorless tubes without any branding, and even the evaluators do not know which is the gel and which is the cream.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with acute fissure aged over 15 years.
Exclusion criteria: Hemorrhoids, anal fistula, anal abscess, pregnancy and lactation, malignant diseases.
Intervention groups
Intervention Group A: Receivers of Barriage Antifischer cream with essence: The cream is to be applied twice daily using an applicator at the anal site.
Intervention Group B: Receivers of 2% Diltiazem gel by Sobhan Darou: The gel is to be applied twice daily using an applicator at the anal site.
Main outcome variables
Fissure grade after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049992N1
Registration date:2025-02-18, 1403/11/30
Registration timing:prospective
Last update:2025-02-18, 1403/11/30
Update count:0
Registration date
2025-02-18, 1403/11/30
Registrant information
Name
Hossein Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5557 8010
Email address
hosseinrezaei9473@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-09, 1403/12/19
Expected recruitment end date
2025-06-09, 1404/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The efficacy of Anti-fissure barij cream and diltiazem gel in severity of pain, bleeding and healing of anal fissure
Public title
Anti-fissure cream and diltiazem gel on anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute fissure
Age more than 15 years old
Randomization method: Block
Unit of randomization: Individual
Randomization tool: Python software with the randint function, random sequence in blocks of four individuals, considering A as Antifischer cream and B as Diltiazem gel, with sequences such as AABB, BBAA, BABA, ABAB, BAAB, ABBA.
Both Antifischer cream and Diltiazem gel are colorless and odorless. Both will be packaged in unmarked, brand-free tubes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the Antifischer cream and the Diltiazem gel are colorless and odorless. They will both be contained in tubes that lack any markings or brand identifiers. Clinical evaluators will receive these tubes and administer them to patients according to specified guidelines, while only the researchers are aware of the type of these tubes. Patients are also unaware whether they are receiving Diltiazem gel or Antifischer cream.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Pezeshk Blvd. - Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.196
Health conditions studied
1
Description of health condition studied
Anal fissure
ICD-10 code
K60.2
ICD-10 code description
Anal fissure, unspecified
Primary outcomes
1
Description
Anal fissure grade after treatment
Timepoint
0, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after treatment
Method of measurement
Clinical examination by a physician and decisions based on the following grades:Grade 0: HealedGrade 1: Fissure with visible internal anal sphincterGrade 2: Deeper fissures with more extensive visibility of the internal anal sphincterGrade 3: Fissure with indeterminate depthGrade 4: Accompanied by perianal fistula
Asking the patient: Score 0: No bleedingScore I (mild): Presence of blood streaks in stoolScore II (moderate): Intermittent bleeding during defecationScore III (severe): Continuous bleeding during defecation
Pain Severity: Numeric Rating Scale (NRS-11) - This is a patient-reported scale used for adults and children aged 10 years or older. It is defined as follows:Score 0: No painScore 1-3: Mild pain (annoying but causes little interference with daily activities)Score 4-6: Moderate pain (significantly interferes with daily activities)Score 7-10: Severe pain (disabling and unable to perform daily activities)
Intervention groups
1
Description
Intervention Group A: Receives Barriage Essence company's Antifischer cream, applied twice daily using an applicator at the anal site. The cream will be provided in 50-gram tubes, uniform in color and size, and filled in the formulation section of Barriage Essence pharmaceutical company.
Category
Treatment - Drugs
2
Description
Intervention Group B: Receives 2% Diltiazem gel from Sobhan Darou company. Applied twice daily using an applicator at the anal site. The gel will be provided in 50-gram tubes, uniform in color and size, and filled in the formulation section of Barriage Essence pharmaceutical company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgical Clinic of Shahid Beheshti Hospital in Kashan.
Full name of responsible person
Abdolhosein Davoodabadi
Street address
Pezeshk Blvd. - Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5547 2939
Email
Davoodabadi-A@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
barijessence company
Full name of responsible person
Abdolhosein Davoodabadi
Street address
Pezeshk Blvd. - Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5547 2939
Email
Davoodabadi-A@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
barijessence company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdolhosein Davoodabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Pezeshk Blvd. - Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5547 2939
Email
Davoodabadi-A@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Abdolhosein Davoodabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Pezeshk Blvd. - Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5547 2939
Email
Davoodabadi-A@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abdolhosein Davoodabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Pezeshk Blvd. - Qotb Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5547 2939
Email
Davoodabadi-A@kaums.ac.ir
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All information related to the participants will be accessible alongside the study protocol.
When the data will become available and for how long
The access period will begin 6 months after the publication of the results.
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
Only academic researchers will have access by submitting a request to the corresponding author.
From where data/document is obtainable
By sending an email to the corresponding author of the paper.
What processes are involved for a request to access data/document
Emails sent to the corresponding author will be reviewed within 3 weeks, and responses will be sent to the individual via email.