Evaluation of the effect of Sodium Pentaborate Ointment on Anal fissure symptoms and treatment
Design
A randomized, double-blind, placebo-controlled phase 2_3 clinical trial with a parallel group on 140 patients.
Settings and conduct
This study is a double-blind, randomized, placebo-controlled study using Sodium Pentaborate or placebo ointment.The subjects are randomly assigned in a 2:1 ratio in intervention or control groups. Patients referred to the Gastroenterology clinics with signs and symptoms of anal fissure are included in the study or are excluded from the study through the entry/exit criteria and if informed consent is given.
Blinding method: a gel that has an active ingredient in boron with a gel of placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color. Identical tubes were labeled as A and B. In blinding, the physician, patient, data analyzer, and researcher will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Anal fissure that is detected in the perineal area by direct observation or rigid anoscopy or flexible colonoscopy- Exclusion criteria: Existence of any perineal complications including dermatitis, condyloma, hemorrhoids, anal abscess- Existence of lateral fissure- Patients with sodium pentaborate allergy- Pregnancy- being under the age of 18- Taking any topical anal medication during the last 7 days
Intervention groups
Intervention group: Topical ointment of 3% sodium pentaborate is applied to the wound for 14 days twice a day in the size of a fingertip
Control group: These are the group that take placebo ointment that has no therapeutic properties.
Main outcome variables
Anal itching; Anal bleeding; Anal pain at rest; Anal pain during defecation Bleeding from the fissure during the examination; Pain at the Fissure site during the examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044062N7
Registration date:2021-07-14, 1400/04/23
Registration timing:retrospective
Last update:2021-07-14, 1400/04/23
Update count:0
Registration date
2021-07-14, 1400/04/23
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
2020-09-05, 1399/06/15
Actual recruitment end date
2021-03-19, 1399/12/29
Trial completion date
2021-03-19, 1399/12/29
Scientific title
Evaluation of the effect of Sodium Pentaborate Topical Ointment on Anal fissure symptoms and treatment
Public title
The effect of Sodium Pentaborate In Anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic anal fissure that is detected in the perineal area by direct observation or rigid anoscopy or flexible colonoscopy.
Exclusion criteria:
Existence of any perineal complications including dermatitis, wart, condyloma, hemorrhoids, fistula, anal abscess
2. Proven Crohn's disease
3. Existence of lateral fissure
4. Patients with sodium pentaborate allergy
5. Pregnancy or breastfeeding
6. Patients with a history of serious cardiovascular, hepatic, renal and blood diseases
7. Taking any topical anal medication during the last 7 days
8. Prohibition of topical use of sodium pentaborate
being under the age of 18
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
140
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used to assign patients to the intervention and control groups with the ratio of 2 for sample size in intervention group to placebo group. The size of the blocks is 6. ( Due to the difficulty in patient recruitment, we considered ratio of 2:1 for sample size in intervention group to placebo group to have more patients in intervention group). Randomization was performed using https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 11 Jul 2021].
Allocation concealment will be done using matte sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
A gel that has an active ingredient in boron with a gel of placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company).
All ointments were either transparent and gelatinous and put in identical tubes by staff not involved further in the trial. Identical tubes were labeled as A and B.
When the physician saw chronic anal fissure on anal examination and the patient has inclusion criteria of the study gave patients A code and B code tubes, respectively. In some hospitals, active molecules were put in A coded tube, and some hospitals in B coded tubes. The randomization codes remained in the pharmaceutical company staff who prepared the drug during the trial and was not available to the investigators. After collecting the data and completing the data analysis stage, the nature of the codes related to the groups will be revealed by the liaison person in the pharmaceutical company.
The important point is that the patient is told that the gel used for the patient may be medication or medication. In blinding, the physician, patient, data analyzer, and researcher will be blind.
Placebo
Used
Assignment
Parallel
Other design features
ratio of 2 for sample size in intervention group to placebo group was considered and 129 patients (intervention group 86 cases, placebo group 43 cases) were needed to give a 80% chance of finding a 25% difference in healing between placebo and GTN at the 5% level. This number was increased by 10% to consider attrition or incomplete data. Finally, 140 cases (90 in intervention and 50 in placebo group) were recruited.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-08-10, 1399/05/20
Ethics committee reference number
IR.TBZMED.REC.1399.512
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 itching
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Ask the patient
2
Description
Anal bleeding
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Ask the patient, inspection of anus and digital rectal examination
3
Description
Anal pain at rest
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Ask the patient
4
Description
Anal pain during defecation
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Ask the patient
5
Description
Bleeding from the fissure during the examination
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Inspection of anus and digital rectal examination
6
Description
Pain at the Fissure site during the examination
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Ask the patient, inspection of anus and digital rectal examination
Secondary outcomes
1
Description
Anal pain during defecation
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Ask the patient
2
Description
Feeling of a mass around the anus
Timepoint
At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment
Method of measurement
Ask the patient
Intervention groups
1
Description
Intervention group: Topical ointment of 3% sodium pentaborate, which is made under GLP and GMP conditions at Yeditpe University in Turkey and is applied to the wound for 14 days (2 weeks) twice a day in the size of a fingertip. The patient is taught for 15 to 30 minutes by an experienced and trained expert.
Category
Treatment - Drugs
2
Description
Control group: These are the group that take placebo ointment that has no therapeutic properties. It is worth mentioning that the participants in this project are patients with chronic anal fissure who have not previously responded to routine treatment (increased consumption of dietary fiber and nifedipine ointment) and for this reason, placebo was used for the control group. We remind you that according to the inclusion criteria, patients should not have used any topical anal drug for at least the last 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Gastroenterology and Endoscopy, Imam Reza Hospital, Tabriz
Full name of responsible person
Manouchehr Khoshbaten
Street address
Golgasht St, Tabriz
City
https://fa.irct.ir/Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
A. Ghasem Jouyban
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
research-vice@tbzmed.ac.ir
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
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
mkhoshbaten@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3337 2088
Email
mkhoshbaten@yahoo.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, which includes information about the main outcome and results, will be shared.
When the data will become available and for how long
available from April 2021
To whom data/document is available
University researchers and professors
Under which criteria data/document could be used
The data will be available to researchers and university professors for the studies of the meta - analysis.
From where data/document is obtainable
Email: niloofarafshin1375@gmail.com
نیلوفر افشین
What processes are involved for a request to access data/document
Request via email: niloofarafshin1375@gmail.com
As soon as possible