1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effectiveness of combination gel (diltigel2%-ureacolchicine) with diltigel 2% in the treatment of acute anal fissures

Protocol summary

Study aim
Comparison of the effectiveness of combination gel (diltigel2% -urea-colchicine) with.diltigel2% in the treatment of acute anal fissures
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 0 on 80 patients. The rand function of Excel software was used for randomization
Settings and conduct
Tabriz University of Medical Sciences
Participants/Inclusion and exclusion criteria
The criteria for entering the study include being over 18 years old, agreeing to participate in the study, suffering from fissure anus as diagnosed by a specialist doctor, and the exclusion criteria from the study include suffering from irritable bowel syndrome, receiving chemotherapy drugs, being under radiotherapy, History of Fisher and hemorrhoid surgery
Intervention groups
From the moment of entering the study, patients will change their lifestyle in the form of using high-fiber foods, avoiding spicy foods, and using laxatives in case of constipation.
Main outcome variables
Effectiveness of combined gel (diltigel2%, urea, colchicine) in the treatment of acute anal fissures: a randomized, single-blind clinical trial 2. Efficacy of Diltigel2% in the treatment of acute anal fissures: a single blind randomized clinical trial 3. Comparing the effectiveness of combined gel (Diltigel, Colchicine- Urea) with Diltigel gel in the treatment of acute anal fissures: a single blind randomized clinical trial

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221203056698N1
Registration date: 2023-10-11, 1402/07/19
Registration timing: prospective

Last update: 2023-10-11, 1402/07/19
Update count: 0
Registration date
2023-10-11, 1402/07/19
Registrant information
Name
Ramin Azhough
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 1629
Email address
azhoughrr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-10, 1402/09/19
Expected recruitment end date
2024-03-17, 1402/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of combination gel (diltigel2%-ureacolchicine) with diltigel 2% in the treatment of acute anal fissures
Public title
Effect of new combination gel in the treatment of acute anal fissures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Consent to participate in the study Suffering from acute anal fissure as diagnosed by a specialist doctor
Exclusion criteria:
Having IBD Receiving chemotherapy drugs Being under radiotherapy History of Fisher and hemorrhoid surgery Receiving medicine and herbal gel for the treatment of fissure Receiving Diltigel before entering the study Receiving lidocaine and tetracycline before entering the study Having gout History of uncontrolled blood pressure Allergy to the drugs used in this study
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients after entering the study in blocks of four in two groups will be divided. Since the primary investigator of this study is the prescribing physician, he is able to be blinded will not be in the course of study; But the person analyzing the data will be unaware of the type of patient grouping The study flow will be blind; Therefore, the present study will be a single-blind study
Blinding (investigator's opinion)
Single blinded
Blinding description
After entering the study, patients will be divided into two groups in blocks of four. Since the first conductor of this study is the prescribing physician, he will not be able to be blind during the study; However, the person analyzing the data as well as evaluating the results, who will be unaware of the type of patient grouping, will be blind during the study; Therefore, the present study will be a double-blind study.
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
golgasht,Tabriz University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.103

Health conditions studied

1

Description of health condition studied
Acute anal fissures
ICD-10 code
K60.2
ICD-10 code description
Anal fissure, unspecified

2

Description of health condition studied
Acute anal fissures
ICD-10 code
K60.2
ICD-10 code description
Anal fissure, unspecified

Primary outcomes

1

Description
The amount of pain in the follow-up periodPatients will be asked.
Timepoint
Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit).
Method of measurement
The intensity of pain will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin. The intensity of pain will be checked with the help of visual pain scale (VAS).

2

Description
The amount of itching in the follow-up periodPatients will be asked
Timepoint
Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit).
Method of measurement
The intensity of itching will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin.and all the datas will be collected by the same person

3

Description
The amount of bleeding in the follow-up periodPatients will be asked.
Timepoint
Patients will be checked for symptoms in the second week (face-to-face visit), the fourth week (telephone follow-up), the sixth week (telephone follow-up), the eighth week (telephone follow-up) and the twelfth week (face-to-face visit).
Method of measurement
The intensity of bleeding will be checked for each patient at the mentioned times and recorded in the data collection form of each person. This form contains information such as age, sex, body mass index, diabetes mellitus, education level, occupation, duration of illness and having crown skin.and all the datas will be collected by the same person

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the patients of this group, 2% Diltigel gel will be administered externally once every twelve hours.
Category
Treatment - Drugs

2

Description
Intervention group: For the patients of the other group, a gel prepared by a pharmacist in the form of a combination of 30 grams of Diltigel 2%, 67 grams of urea, and 3 grams of colchicine will be prescribed twice a day and externally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical School of Tabriz University Of Medical sciense
Full name of responsible person
Ramin Azhugh
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3332 5360
Email
danesh@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi (Research assistant of Tabriz University of Medical Science)
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3336 5890
Email
danesh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
20
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
Ramin Azhugh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 6047
Email
danesh@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Azhugh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3333 5698
Email
danesh@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Azhugh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
gholghasht
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
0413335698
Email
danesh@tbzmed.ac.ir

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...