In this Randomized double-blind clinical trial study, patients with internal hemorrhoid or chronic anal fissure are divided in two groups. In case group patients apply a mixture of honey and Vaseline with ratio of 1:2 and in control group patients use Vaseline as placebo topically. The patients are asked to apply 1 to 2 gram of the ointments with applicators into the anal canal two times a day. They are followed for 10 days, and visited every 5 days. Severity of pain, pruritus and bleeding are evaluated during the course of trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122615162N2
Registration date:2014-01-09, 1392/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-09, 1392/10/19
Registrant information
Name
Jafar Alavy Toussy
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 7244
Email address
drtoussy@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2011-03-11, 1389/12/20
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of topical honey on on symptoms of hemorrhoid and anal fissure in patients of surgery clinics of Semnan, Iran
Public title
Effect of topical honey on on symptoms of hemorrhoid and anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic anal fissure (anal fissure that has not cured after 6-8 weeks), patients with internal hemorrhoid - Exclusion criteria: Patients who received any other medical treatment for these diseases in the week before the trial; patients with acute fissure; patients with external hemorrhoid; patients that need any other treatment for these diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences ethics committee
Street address
Deputy of Research, Basij Boulevard
City
Semnan
Postal code
Approval date
2010-11-21, 1389/08/30
Ethics committee reference number
92/374021
Health conditions studied
1
Description of health condition studied
Chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
2
Description of health condition studied
Internal haemorrhoids without complication
ICD-10 code
I84.2
ICD-10 code description
Internal haemorrhoids without complication
Primary outcomes
1
Description
Severity of pain
Timepoint
Begining of study, 5th day, End of study
Method of measurement
Numeric rating pain scale
2
Description
Pruritus
Timepoint
Begining of study, 5th day, End of study
Method of measurement
Questionnaire
3
Description
Bleeding
Timepoint
Begining of study, 5th day, End of study
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, mixture of honey and Vaseline with ratio of 1 to 2, 1 to 2 gr BD is applied by use of applicator through anal canal. The honey that is used is without wax with commercial mark of Mahram corporation (Iran).
Category
Treatment - Drugs
2
Description
In control group, Vaseline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery clinic of Amir-al-Momenin Hospital
Full name of responsible person
Dr Setareh Soltany
Street address
Surgery department, Koosar Hospital, Shahrak-e Golestan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Deputy of Research, Basij Boulevard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?