.The goal of this study was comparison the effect of Boric acid and Polymixin NH on the treatment of patients with acute external otitis. This is a double blind clinical trial study that was done on patients with acute external otitis who came to ENT clinic.Inclusion criteria: Patients older than 18 years with acute external otitis.Exclusion criteria: Patients that had used systemic or local antibiotics during last two weeks; diabetic paitients; patients with immunosupresive disorders. This study was done on 80 paitients.The paitients were divided in two groups, in the first group ear drop Polymixin NH was prescribed, three drops every eight hours for ten days. In the second group ear drop Boric acid was prescribed, three drops every eight hours for ten days. This study was done between 21/04/2014 and 22/09/2014. primary outcome was pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409256252N6
Registration date:2015-05-19, 1394/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-19, 1394/02/29
Registrant information
Name
Soroush Amani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
samani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Scienses
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Boric Acid and Polymixin NH on the treament of acute otitis externa
Public title
Comparison of the effect of Boric Acid and Polymixin NH on the treament of external otitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients older than 18 years with acute external otitis.
Exclusion criteria: Patients that had used systemic or local antibiotics during last two weeks; Diabetic paitients; Patients with immunosupresive disorders.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sharekord University of Medical Sciences
Street address
Kashani Avenue, Shahrekord
City
Shahrekod
Postal code
8815713471
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1048
Health conditions studied
1
Description of health condition studied
Acute External Otitis
ICD-10 code
H60.3
ICD-10 code description
diffuse infective otitis externa
Primary outcomes
1
Description
earahce
Timepoint
first day, third day, seventh day and tenth day
Method of measurement
MC Gill Pain Questionnaire
Secondary outcomes
1
Description
discharge from ear
Timepoint
first day, third day, seventh day and tenth day
Method of measurement
clinical evaluation
2
Description
swelling of ear canal
Timepoint
first day, third day, seventh day and tenth day
Method of measurement
clinical evaluation
3
Description
tenderness of auricle
Timepoint
first day, third day, seventh day and tenth day
Method of measurement
clinical evaluation
Intervention groups
1
Description
In the first group ear drop Polymixin NH was prescribed, three drops every eight hours for ten day.
Category
Treatment - Drugs
2
Description
In the second group ear drop Boric acid was prescribed, three drops every eight hours for ten day.