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Clinical trial Study of the effect of Myrtoid and 2% diltiazem with placebo in treatment of complications of chronic anal fissure patients

Protocol summary

Study aim
1- Comparison of the Effect of Myrtoid and 2% diltiazem with placebo in treatment of pain of chronic anal fissure patients 2- Comparison of the effect of Myrtoid and 2% diltiazem with placebo in treatment of itching of chronic anal fissure patients
Design
Clinical trials with a community-based and pragmatic control group with parallel, randomized groups, Group 1: Plasma suppository treatment, Group 2: Treatment with diltiazem gel 2%, Group 3: Treatment with Myrtoid suppository, randomization method Simple randomization, randomization unit: individual, randomization tool: random number table, the triple blinded, The total sample size of 99 patients with at least 2 months of a chronic anal fissure in 3 groups, clinical trial phase: 3.
Settings and conduct
Chronic anal fissure is a common anorectal disease that presents with pain and bleeding during bowel movements. Pain, spasm and ischemic injuries caused by improper repair become a fissure to be chronic from. This study aimed to compare the effects of Myrtoid and 2% diltiazem with placebo in treatment of patients of chronic anal fissure . Patients referred to the Baqiyatallah hospital who were diagnosed with at least 2 months of chronic anal fissure. In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware about intervention. Clinical trials with a community-based and pragmatic control group with parallel, randomized groups, Group 1: Plasma suppository treatment, Group 2: Treatment with diltiazem gel 2%, Group 3: Treatment with Myrtoid suppository, randomization method Simple randomization, randomization unit: individual, randomization tool: random number table, the triple blinded, The total sample size of 99 patients with at least 2 months of a chronic anal fissure in 3 groups, clinical trial phase: 3.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least 2 months of chronic anal fissure Exclusion criteria: Patients with Crohn's disease, patients with colon cancer, patients with diabetes, history of anal surgery
Intervention groups
Group 1: Plasma plus suppository, Group 2: Treatment with diltiazem gel 2%, Group 3: Treatment with Myrtoid suppository
Main outcome variables
Pain, Itching

General information

Reason for update
Acronym
اثیر میرتویید با دیلتیازم 2% و پلاسیبو در درمان عوارض بیماران با فیشرآنال مزمن
IRCT registration information
IRCT registration number: IRCT20160914029818N3
Registration date: 2018-01-27, 1396/11/07
Registration timing: registered_while_recruiting

Last update: 2018-01-27, 1396/11/07
Update count: 0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Shahram Manoochehry
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 3766
Email address
shahram.manoochehry@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Study of the effect of Myrtoid and 2% diltiazem with placebo in treatment of complications of chronic anal fissure patients
Public title
The effect of Myrtoid and 2% diltiazem with placebo in treatment of complications of chronic anal fissure patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 2 months of chronic anal fissure
Exclusion criteria:
Patients with Crohn's disease Patients with colon cancer Patients with diabetes History of anal surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 99
Actual sample size reached: 99
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table, there is not allocation concealment.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware about intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Approval date
2017-06-02, 1396/03/12
Ethics committee reference number
IR.Bmsu.rec.1396.3

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
Pain
Timepoint
Two weeks after traetment
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Itching
Timepoint
Two weeks after treatment
Method of measurement
Questionnaires with Likert scale ( low, medium and high)

Intervention groups

1

Description
Intervention group: Myrtoid
Category
Treatment - Drugs

2

Description
Intervention group: 2% diltiazem
Category
Treatment - Drugs

3

Description
Control group: Suppository placepo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Surgery Department of Baqiyatallah hospital
Full name of responsible person
Sahram Manoochehry
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee St, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
shahram.manoochehry@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hamid Reza Rasouli
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
hr.rasouli64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shahram Manoochehry
Position
Faculty member/General surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
shahram.manoochehry@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shahram Manoochehry
Position
Faculty member/General surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
shahram.manoochehry@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shahram Manoochehry
Position
Faculty member/General surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Postal code: 1435917541, Mollasadra Street, Sheikh Bahaee Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435917541
Phone
+98 21 8805 3766
Email
shahram.manoochehry@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Yes - There is 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
Title and more details about the data/document
Clinical trial Study of the effect of Myrtoid and 2% diltiazem with placebo in treatment of complications of chronic anal fissure patients
When the data will become available and for how long
In 2018
To whom data/document is available
Shahram Manoochehry
Under which criteria data/document could be used
Analysis
From where data/document is obtainable
Shahram Manoochehry
What processes are involved for a request to access data/document
Publish in journal
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