This single-blind clinical trial will be performed on 204 patients with confirmed diagnosis of otomycosis who visit the special ENT clinic of Imam Reza and Valiasr hospitals affiliated to Birjand University of Medical Sciences during the second half of 1393 (hijri). In case there are clinical symptoms such as pain, pruritus, extra mass in external ear canal, and discharge, the patient will be regarded as suspect of otomycosis whereupon drainage will be sampled in a sterilized manner. After the KOH smear is prepared and fungal elements are observed, otomycosis will be confirmed. Patients will enter the study upon informed consent and will be allocated to the control (local chloroimidazole drop) or case (betadin solution) groups through randomized blocking. Patients will be examined by an ENT specialist unaware of the treatment 4, 10 and 20 days after intervention. Upon definite response, treatment will stop. Otherwise, treatment will continue. Non-response after 20 days will be considered as treatment-resistant, and treatment will continue by tolnaftate and violet de gentian diets.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014123020484N1
Registration date:2015-12-03, 1394/09/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-03, 1394/09/12
Registrant information
Name
Mohammad Hasan Namaei
Name of organization / entity
Birjand University of Medical Scie
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5409
Email address
mhnamaei@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of healing Otomycosis using clotrimazole topical povidone iodine therapy
Public title
External ear fungal infection treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ear pain or pruritus; existence of clinical findings of skin erythema in external ear canal; ear occlusion along with hearing loss and discharge; discharge of puss from ear in recent 7 days; positive laboratory report confirming otomycosis.
Exclusion criteria: media otitis along with stenosis in external ear canal; chronic era discharge; a history of ear surgery; a history of anti-fugnal and corticosteriods treatment; external ear anomaly; perforation of tympanic membrane,
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
204
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
South Khorasan- Birjand University of Medical Sciences
City
Birjand
Postal code
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
IR.BUMS.1392.16
Health conditions studied
1
Description of health condition studied
Otomycosis
ICD-10 code
+B36.9
ICD-10 code description
Superficial mycosis, unspecified
Primary outcomes
1
Description
Otomycosis
Timepoint
4, 10, and 10 days after treatment
Method of measurement
Ear examination
Secondary outcomes
empty
Intervention groups
1
Description
The waste mass in the ear canal and also in the presence of pus and fluid in the ear canal will be removed. After removal of the waste, the patient's ear canal will be cleaned with Betadine solution. This work will continue until the ear canal is completely clean
Category
Treatment - Other
2
Description
The waste mass in the ear canal and also in the presence of pus and fluid in the ear canal will be removed. After removal of debris, antifungal drop "clotrimazole" will be administered 3 drops every eight hours, for 4 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza and Valiasr hospitals affiliated to Birjand University of Medical Sciences
Full name of responsible person
MohammadHasan Namaei
Street address
South Khorasan- Birjand- Birjand University of Medical Sciences
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
GholamReza Sharifzade-MSc in Epidemiology- Research Director of University
Street address
South Khorasan- Birjand- Birjand University of Medical Sciences
City
Birjand
Grant name
بودجه های جاری معاونت تحقیقات
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand- Birjand University of Medical Sciences
Full name of responsible person
MohammadReza Mofatteh
Position
Ear, nose and throat specialist-Faculty of Birjand University of Medical Sciences,
Other areas of specialty/work
Street address
South Khorasan- Birjand- Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 56 3225 2437
Fax
Email
Drmoffateh@yahoo.com
Web page address
www.bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand- Birjand University of Medical Sciences
Full name of responsible person
Zahra Naseri Poor Yazdi
Position
Professional medical-doctoral students
Other areas of specialty/work
Street address
South Khorasan- Birjand- Birjand University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3881 7764
Fax
Email
znaseripy@gmail.commhnamaei@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)