1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effectiveness, recurrence rate and side effects of two therapeutic methods of Botulinum toxin injection and topical Diltiazem in the treatment of patients with chronic anal fissures

Protocol summary

Study aim
Determining and comparing the clinical effectiveness, recurrence and side effects of two therapeutic methods of botulinum toxin injection and local diltiazem in the treatment of chronic anal fissure.
Design
Clinical trial with two intervention groups with accessible sampling method, phase 2 on 60 patients.
Settings and conduct
With the available sampling method, a number of patients with chronic anal fissure who refer to the surgery clinic of Gonabad city are selected. After receiving the necessary information about how to perform both treatment methods, patients consciously choose a group. Finally, using the relevant checklists that are completed by the patient and the specialist doctor, the treatment results and side effects of the two methods are checked and compared.
Participants/Inclusion and exclusion criteria
Age between 18 and 80 years, no immune deficiency, no inflammatory bowel diseases and no tuberculosis, no recurrent anal fissure and complex anal fissure, no colon malignancy, no pregnancy, no reaction and allergy to medicinal substances
Intervention groups
In the diltiazem (A) group, 2% diltiazem ointment is prescribed locally around the anus three times a day (every 8 hours) for one week. In the toxin group (B), 100 units of Botox are injected in four divided doses of 25 units at 3, 6, 9, and 12 hours in the internal anal sphincter.
Main outcome variables
Clinical efficacy and disease recovery; Rate of disease recurrence; The amount of side effects; Duration of response to treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230607058408N1
Registration date: 2023-06-29, 1402/04/08
Registration timing: prospective

Last update: 2023-06-29, 1402/04/08
Update count: 0
Registration date
2023-06-29, 1402/04/08
Registrant information
Name
Fahime Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 0779
Email address
fahimemehrabi99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness, recurrence rate and side effects of two therapeutic methods of Botulinum toxin injection and topical Diltiazem in the treatment of patients with chronic anal fissures
Public title
Investigating the effect of topical diltiazem and botulinum toxin injection in the treatment of chronic anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with chronic anal fissure between the ages of 18 and 80
Exclusion criteria:
Immune deficiency (using corticosteroids for more than 3 months, patients receiving transplants, receiving chemotherapy or radiotherapy, HIV positive patients with CD4 less than 200) Inflammatory bowel diseases Tuberculosis Recurrent anal fissure and complicated anal fissure (stenosis, abscess, fistula or hemorrhoids) Colon malignancy Pregnancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
How to assign people to two intervention groups: with the available sampling method, a number of patients with chronic anal fissure referring to the surgery clinic are selected and after receiving the necessary information about how to perform both treatment, They consciously choose a group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of gonabad university of mwdical sciences
Street address
Gonabad university of medical sciences , DR Mahdizade Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.GMU.REC.1401.173

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
Chronic anal fissure
Timepoint
Examination of anal fissure at the beginning of the study and 14 days later and at the end of the first, second, fourth and sixth months after the intervention
Method of measurement
Checklist and questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group one: Injection of 100 units of Botox in four divided doses of 25 units at 3, 6, 9 and 12 hours in the internal anal sphincter
Category
Treatment - Drugs

2

Description
Intervention group two: Administration of 2% diltiazem ointment topically around the anus three times a day (every 8 hours) for one week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Bahloul Gonabad Hospital
Full name of responsible person
Fahime Mehrabi
Street address
Gonabad university of medical sciences , DR Mahdizade Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Fahimemehrabi99@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Leila Sadeq moghadam
Street address
Gonabad university of medical sciences , DR Mahdiade Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Fahimemehrabi99@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Fahime Mehrabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Gonabad university of medical sciences , DR Mahdizade Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Fahimemehrabi99@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fahime Mehrabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Gonabad university of medical sciences , DR Mahdizade Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Fahimemehrabi99@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fahime Mehrabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Gonabad university of medical sciences , DR Mahdizade Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Fahimemehrabi99@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...