In this study, egg yolk enema was compared to nitroglycerin ointment in treatment of acute anal fissure. Patients with acute anal pain and rectorrhagia diagnosed by a gastroenterologist as an acute fissure without any underlying diseases who passed the eligible criteria, after the relief of symptoms and definitive diagnosis by doing colonoscopy and filling the testimonial were randomly divided into 2 groups. The study was a double blind clinical trial. The patients and the statistical analyst were unaware of the two groups. For the first group nitroglycerin ointment (0.2%) and for second group one egg yolk enema was administered. Then the severity of bleeding and pain were reviewed every two days until ten days. The results were recorded in research questionnaires and they were analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050718915N3
Registration date:2015-06-12, 1394/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-12, 1394/03/22
Registrant information
Name
Mousalreza Hosseini
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 80 1274 2513
Email address
hoseinimr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashad University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of egg yolk with nitroglycerin ointment in treatment of acute anal fissure.
Public title
The effect of egg yolk in treatment of acute anal fissure.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with acute anal pain with or without rectorrhagia diagnosed by a gastroenterologist as an acute anal fissure.
Exclusion criteria: Patients with underlying diseases (crohn disease, hemorrhoid)
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients and the statistical analyst were unaware of the two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashad University Of Medical Sciences
Street address
Goreyshi Building, Daneshgah Street, Mashad University Of Medical Sciences
City
Mashhad
Postal code
Approval date
2014-05-27, 1393/03/06
Ethics committee reference number
87898
Health conditions studied
1
Description of health condition studied
Acute anal fissure
ICD-10 code
K60.0
ICD-10 code description
Fissure and fistula of anal and rectal regions
Primary outcomes
1
Description
The effect of egg yolk in treatment of acute anal fissure.
Timepoint
The severity of bleeding and pain were reviewed every two days until ten days.
Method of measurement
Through research questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The second group has received one egg yolk enema.
Category
Treatment - Other
2
Description
The first group has received nitroglycerin ointment (0.2%)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mousalreza Hosseini
Street address
Internal Department, Ghaem Hospital, Ahmadabad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for research, Mashad University of Medical Sciences Vice
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreishi Biulding, Danseshgah Street, Research Vice Chanecellary, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for research, Mashad University of Medical Sciences Vice