Paying attention to the effects of Metronidazole as a new method in treating patients with anal fissure
Design
Randomised, blinded, controlled clinical trial with a parallel group design of 54 patients.Randomisation was centralised with Random allocation software
Settings and conduct
This study will be conducted in 1401 to 1402 on patients suffering from chronic fissure referred to the Gastroenterology Clinic of Taleghani Hospital (Tehran). They are randomly divided into intervention group (use of Metronidazole gel) and control group by using coin toss. Metronidazole has an identification code and is distributed in the same package as Diltiazem gel. For blinding, the participant, clinical caregiver, researcher, and outcome assessor are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: people willing to participate in the study by obtaining written consent without age and gender restrictions, presence of chronic fissure؛
Exclusion criteria: patients with other colorectal diseases, people who are not able to regularly participate in follow-up visits, acute anal fissure
Intervention groups
Patients are randomly divided into intervention and control groups. In the intervention group,topical Metronidazole gel will be used 3 times a day for 14 days, and only topical Diltiazem will be used in the control group
Main outcome variables
Determination of pain intensity in patients with chronic anal fissure treated with Metronidazole and Diltiazem gel after 10 days;
Determination of pain intensity in patients with chronic anal fissure treated with Metronidazole and Diltiazem gel after 21 days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221102056377N1
Registration date:2023-01-18, 1401/10/28
Registration timing:prospective
Last update:2023-01-18, 1401/10/28
Update count:0
Registration date
2023-01-18, 1401/10/28
Registrant information
Name
Simin Dokht Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3318 6469
Email address
simindokht_nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Metronidazole and Diltiazem Gel in Pain Control in Chronic Anal Fissure Patients
Public title
"Effect of Topical Metronidazole in treatment of chronic fissure"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All individuals with anal fissures for more than 6 weeks
Exclusion criteria:
Suffering from other colorectal diseases
The person is unable to participate in follow-up visits
Duration of symptoms less than 6 weeks
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, people were divided into intervention and control groups by simple randomization method, using the coin tossing method. Then Random allocation software was used to create a random sequence. Coded boxes with random sequences were used for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Topical Metronidazole has an identification code and is supplied in the same packaging and appearance as topical Diltiazem, which will cause blinding of the participants, researchers and outcome assessors
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shahid Beheshti University of Medical Sciences
Street address
No. 4 , Karimi Alley., Ghafari St., South Kargar Ave
City
Tehran
Province
Tehran
Postal code
1333714641
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.SBMU.MSP.REC.1401.316
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
Determination of pain intensity in patients with chronic anal fissure treated with Metronidazole gel and diltiazem
Timepoint
Determination of pain intensity in patients with chronic anal fissure at the beginning of the study and 10, 21, 28 days after starting Metronidazole
Method of measurement
Examination of Anus; Use of Visual Analogue Scale
2
Description
Determining the duration of pain in patients with chronic anal fissure treated with Metronidazole gel and Diltiazem
Timepoint
Determining the duration of pain in patients with chronic anal fissure at the beginning of the study and 10, 21, 28 days after starting Metronidazole
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, topical Metronidazole 0.75% (Pars Daro Pharmaceutical Company) will be used 3 times a day for 14 days
Category
Treatment - Drugs
2
Description
Control group: In the control group, only laxatives, high-fiber diet and topical Diltiazem (Soban Daru Pharmaceutical Company) will be used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Taleghani Hospital(Tehran)
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Amir Sadeghi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi St., Yemen St., Chamran High way., Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
amirsadeghi@yahoo.com
Web page address
https://amirsadeghimd.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Amir Sadeghi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi St., Yemen St., Chamran High way., Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
amirsadeghi@yahoo.com
Web page address
https://amirsadeghimd.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Simin Dokht Nazari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 4, Karimi Alley., Ghafari st., Ghazvin St
City
Tehran
Province
Tehran
Postal code
1333714641
Phone
+98 21 3318 6469
Fax
Email
simindokht_nazari@sbmu.ac.ir
Web page address
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
By registering the results of the clinical trial in one of the prestigious medical journals inside or outside the country
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
All researchers working in academic and scientific institutions and the industry sector
Under which criteria data/document could be used
The data obtained from the clinical trial can be used by medical students, internists, gastroenterologists, surgeons and pharmacists to help treat patients with chronic fissure
What processes are involved for a request to access data/document
After submitting the application through one of the mentioned ways and checking the person's profile, the information will be provided to the person after a time interval of approximately one month