The purpose of the present study is assessing the effectiveness of clotrimazole in preventing relapse is Otomycosis. In this study, at least 300 patients with Otomycosis will be place in two groups; case (with the administration of clotrimazole) and control (without administration of clotrimazole). In this study, all patients with suspected to Otomycosis referred to ear, nose and throat of Ayatollah Rouhani Hospital of Babol (one center) are enrolled. The absence of fungal infection and perforation in tympanic membrane may be excluded. Discharge will be removed using a sterile speculum for the ear for direct examination and culture on medium. In case with a positive result of fungal in direct examination, as a person with Otomycosis (inclusion criteria) will be considered. These peoples will be placed in two groups, randomly using sealed envelope. In case patients, after the initial treatment (as symptoms deleted, maximum in 2 weeks) immediately entered into the treatment phase; for this purpose a solution of clotrimazole 1% manufacturing pharmaceutical company Pars Daro for 1 month and 3 times a week, 2-3 drop for day will be used. Patients in the control group after treatment to prevent recurrence of Otomycosis will not use any drug. Recurrence rate of Otomycosis will be determined after three months with clinical and laboratory re-examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040513136N3
Registration date:2016-02-09, 1394/11/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-09, 1394/11/20
Registrant information
Name
Saeid Mahdavi Omran
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9936
Email address
s.mahdavi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2018-02-03, 1396/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of clotrimazole 1% on reccurence of Otomycosis after treatment.
Public title
The effect of clotrimazole on prevention of Otomycosis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Otomycosis (Direct examination, or sometimes culture result).
Exclusion criteria: Tympanic perforation.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There is any study in Iran.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Babol University of Medical Sciences
Street address
Babol, Ganj Afrooz Street
City
Babol
Postal code
4717647745
Approval date
2015-12-15, 1394/09/24
Ethics committee reference number
6446/30/P/J
Health conditions studied
1
Description of health condition studied
Otomycosis
ICD-10 code
H62.2
ICD-10 code description
B36.9
Primary outcomes
1
Description
Recurrence
Timepoint
3 month
Method of measurement
Patient complaints and clinical examination
Secondary outcomes
1
Description
None
Timepoint
None
Method of measurement
None
Intervention groups
1
Description
Case group: After initial treatment and clinical survey (after 2 weeks), Clotrimazole 1% drop, manufacture by pharmaceutical company- Pars Daro, 2-3 drops /day, 3 times/ week, for 1 month will be use.
Category
Treatment - Drugs
2
Description
Control group: These pateints will not received any drug to prevent recurrence after treatment, But refereed after 2 weeks for treatment result by clinical survey.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Ayatollah Rouhani Hospital
Full name of responsible person
Dr. Keyvan Kiakojouri
Street address
Babol, Ganjafrooz St.
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Babol University of Medical Sciences
Full name of responsible person
Dr. Bijani
Street address
Ganjafrooz St.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Babol 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
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Saeid Mahdavi Omran
Position
Scientific Board
Other areas of specialty/work
Street address
Ganj Afrooz St.
City
BAbol
Postal code
4717647745
Phone
+98 11 3219 9936
Fax
Email
s.mahdavi@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
keyvan Kiakojuri
Position
MD, Fellowship
Other areas of specialty/work
Street address
Ganj Afrooz St.
City
Babol
Postal code
4717647745
Phone
+98 11 3219 9591
Fax
Email
kia_ko13358
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Saeid Mahdavi Omran
Position
Mycologist/ Scientific Board
Other areas of specialty/work
Street address
Ganj Afrooz St.
City
Babol
Postal code
4717647745
Phone
+98 11 3219 9936
Fax
Email
s.mahdavi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)