This study was to investigate the therapeutic effect of Miconazole cream 1% and clotrimazole 1% cream in the treatment of the patients who referred to the hospital during the years 2015 to Amir al momenin hospital and diagnosed as otomycosis based on clinical examination. Exclusion criteria included: patient who have otitis externa with canal stenosis; previous ear surgery ;
Patients with Diabetes mellitus ; chronic ear discharge and immunodeficiency. patients devided into three groups: A, B and وC and basis of the age and sex of the three groups will be matched. Group A(acidified and debridement is used along with a placebo), B (acidified and miconazole cream 1% mobile debridement) ,Group C( acidified and debridement with cream clotrimazole 1%) after a week and then creams will be off under the microscope examination. all patients will be visited at the end of first and second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502241138N15
Registration date:2015-03-26, 1394/01/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Science, Vice Chancellor for Resarch
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of clotrimazole 1٪cream with miconazole 1٪ cream in treatment of otomycosis-2014
Public title
Efficacy of clotrimazole 1 ٪ and miconazole1% in otomycosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: All patients who visit in Amir-Al.. and have a clinical diagnosis for otomycosis. Exclusion: Otitis externa along with external ear canal stenosis;a history of ear surgery; diabetes mellitus; immunocompromise ; chronic discharging ear
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
GuilanUniversity of Medical Sciences
Street address
Tehran avenue
City
Rasht
Postal code
4139637459
Approval date
2014-12-30, 1393/10/09
Ethics committee reference number
1930459701
Health conditions studied
1
Description of health condition studied
otomycosis
ICD-10 code
H62.2
ICD-10 code description
Otitis externa in mycoses
Primary outcomes
1
Description
Fungal otitis externa
Timepoint
Weekly up to 2 week and at the end of 4th week.
Method of measurement
Clinical examination
Secondary outcomes
1
Description
The patient's response to creams
Timepoint
Weekly up to 2 week and at the end of 4th week.
Method of measurement
Clinical examination
Intervention groups
1
Description
for B acidified and miconazole cream 1% and debridement can be prescribed as creams on the ear by a ENT specialist clinic with the help of a small syringe (2cc) and 18 gauge IV catheter into the external ear canal is infused cream due to the shape of the ear canal and viscosity remains within the canal. this cream will remain for a week inside the ear canal ... after a week and then cream will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with cream. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.
Category
Treatment - Drugs
2
Description
For Group C acidified and debridement with cream clotrimazole cream 1% is prescribed in the clinic with the help of a small syringe (2cc) and 18 gauge IV catheter into the external ear canal. this cream will remain for a week inside the ear canal ... after a week and then cream will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with cream. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.
Category
Treatment - Drugs
3
Description
For Group A, acidified and debridement is used along with a placebo .placebo will remain for a week inside the ear canal ... after a week and then placebo will be off under the microscope examination. then again for another week by the ear canal Same as previous is filled with placebo. all patients at the end of the second week and re-examination of the ear canal patients with therapeutic response of Good/Moderate response at the fourth week following by microscopic examination for viewing again relapse.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralamomenin Hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Science, Vice Chancellor for Resarch
Full name of responsible person
Susan Komaee
Street address
Namjou, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Science, Vice Chancellor for Resarch
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Hooshang Gerami
Position
Professor
Other areas of specialty/work
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht
Postal code
4139637459
Phone
+98 13 3322 5242
Fax
Email
hg_gerami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Hooshang Gerami
Position
Professor
Other areas of specialty/work
Street address
Amiralamomenin Hospital, 17 shahrivar St
City
Rasht
Postal code
4139637459
Phone
+98 13 3322 5242
Fax
Email
hg_gerami@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)