Comparison of the effectiveness topical diltiazem and nefidipin in improving symptom and healing in patient with acute fissure
Design
This study was designed as a single-blinded randomized clinical trial with parallel groups and a sample size of70 people in each group
Settings and conduct
The study will be conducted at Ziaeian Hospital on patients with acute fissure . Patients who signed informed consent will be randomly divided into two groups. The first group will received 0.3% nifedipine ointment ( Synthesized in the pharmacy of Razi Hospital affiliated to Tehran University of Medical Sciences),Peri-anally , three times a day, quantity of a knuckle for 2 months. The Group-B will treated by 2% diltiazem ointment (Sobhan Company) Peri-anally , three times a day, amount of a knuckle for 2 months .The final outcome of the study will be assessed by a third party who is unaware of the study process. Also, the statistician will be unaware of the study process
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Participants/Inclusion and exclusion criteria
Conditions for entry over the age of 18, Acute fissure,
exclusion criteria history of anal surgery, Anorectal malformation and pregnancy
Intervention groups
Group-A will received 0.3% nifedipine ointment, Synthesized in the pharmacy of Razi Hospital affiliated to Tehran University of Medical Sciences, Peri-anally , three times a day, quantity of a knuckle for 2 months
Group-B will treated by 2% diltiazem ointment (Sobhan Company) Peri-anally , three times a day, amount of a knuckle for 2 months
Main outcome variables
Duration of pain, healing and relapse of fissure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190414043275N1
Registration date:2021-07-05, 1400/04/14
Registration timing:prospective
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Zahra Momayez sanat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 9645
Email address
z-msanat@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-22, 1400/04/31
Expected recruitment end date
2021-12-20, 1400/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness topical diltiazem and nefidipin in improving symptom and healing in patient with acute fissure
Public title
Diltiazem in fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute fissure
Exclusion criteria:
Pregnancy
history of anal surgery
Anorectal malformation
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Investigator
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization approach will be implemented in this study. Randomization will be performed using a computer-generated list. For this purpose, 140 sealed envelopes will be numbered 1-140 according to the randomization list. Group allocation will be kept separate until the study is completed. The randomization ratio would be 1: 1, with 70 envelopes allocated to each group
Blinding (investigator's opinion)
Single blinded
Blinding description
Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Due to the type of intervention, participants are aware of the type of treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran university of medical science
Street address
jalal al ahmad shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.420
Health conditions studied
1
Description of health condition studied
Acute anal fissure
ICD-10 code
K60.0
ICD-10 code description
Acute anal fissure
Primary outcomes
1
Description
Duration of pain
Timepoint
Before the intervention, every week for up to 8 weeks after the intervention
Method of measurement
Question from the patient
Secondary outcomes
1
Description
healing of anal fissure
Timepoint
After two months of intervention
Method of measurement
Physical examination
2
Description
Relapse
Timepoint
6 months after intervention
Method of measurement
Question from the patient
Intervention groups
1
Description
Group-A will received 0.3% nifedipine ointment, Synthesized in the pharmacy of Razi Hospital affiliated to Tehran University of Medical Sciences, Peri-anally , three times a day, quantity of a knuckle for 2 months
Category
Treatment - Drugs
2
Description
Group-B will treated by 2% diltiazem ointment (Sobhan Company) , Peri-anally , three times a day, amount of a knuckle for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
zieaan
Full name of responsible person
zahra momayez sanat
Street address
jalal ale ahmad shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 84901
Email
msanat67@ gmail .com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zhra momayz sanat
Street address
jalale ale ahmad shariati hospital
City
تهران
Province
Tehran
Postal code
1411713135
Phone
+98 21 84901
Email
msanat67@ gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
private
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra momayez sanat
Position
associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
jalale ale ahmad shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 84901
Email
msanat67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra momayez sanat
Position
associated professore
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
jalale ale ahmad shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8863 3039
Email
msanat67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra momayez sanat
Position
associated professore
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
jalale ale ahmad shariaty hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8863 3039
Email
msanat67@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