Randomized comparative clinical trial of topical triamcinolone in orabase (Adcortyle) and Myrtus communis (Myrtex) 5% solution for the treatment of aphthous ulcer
The aim of this study is to compare the therapeutic effect of topical triamcinolone in orabase with Myrtus communis topical solution for the treatment of aphthous stomatitis. The study encompasses all the patients with minor aphthousis referring to the private office and sample size includes 100 patients which will be divided into intervention and control groups based on randomized blocking method. Inclusion criteria: 1- age range: 18-50 years, 2- size of lesions: 2-4 mm in diameter, 3- number of lesions: 1-5. Exclusion criteria: 1- pregnancy, 2- lactation, 3- present history of any malignancy , 4- Behcet's syndrome. This study was approved by Ethical Review Committee of Kurdistan University of Medical Sciences. After informed consent the intervention group will use 5% Myrtus communis topical solution 10 drops on the lesions for 20 second, 5 times/day. Control group will use topical triamcinolone in orabase 4 times/day on the lesions. The patients were followed one week after treatment for assessment of pain relief and healing of the mucosal lesions by a dermatologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801201802N1
Registration date:2009-11-07, 1388/08/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-11-07, 1388/08/16
Registrant information
Name
Farrokh Rad
Name of organization / entity
Kurdistan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 1374
Email address
dr_farokh.rad@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2008-08-22, 1387/06/01
Expected recruitment end date
2009-06-22, 1388/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized comparative clinical trial of topical triamcinolone in orabase (Adcortyle) and Myrtus communis (Myrtex) 5% solution for the treatment of aphthous ulcer
Public title
The comparison of topical corticosteroid and Myrtex solution in the treatment of aphthous
stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- age range: 18-50 years, 2- size of lesions: 2-4 mm in diameter, 3- number of lesions: 1-5.
Exclusion criteria: 1- pregnancy, 2- lactation, 3- present history of any malignancy, 4- Behcet's Syndrome
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethical Review Commiitee of Kurdistan University of Medical Sciences
Street address
Pasdaran St.
City
Sanandaj
Postal code
Approval date
2008-07-15, 1387/04/25
Ethics committee reference number
3755پ14پ
Health conditions studied
1
Description of health condition studied
Oral aphthous ulcer
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Pain relief
Timepoint
one week after treatment
Method of measurement
history of the patients
2
Description
Healing of the aphthous ulcer
Timepoint
one week after treatment
Method of measurement
clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Myrtus communis topical solution 10 drops, 5 times/day for 20 seconds on the lesions
Category
Treatment - Drugs
2
Description
Control group: Topical triamcinolone in orabase, four times/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private office
Full name of responsible person
Dr. Farrrokh Rad
Street address
Morvarid building, Pasdaran St.
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Ataollah Haydari
Street address
Pasdaran St.
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Farrokh Rad
Position
Dermatologist, Assistant proffessor of dermatology department
Other areas of specialty/work
Street address
Dermatology clinic , Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
Phone
+98 87 1328 5913
Fax
Email
dr_farokh.rad@muk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Farrokh Rad
Position
Assistant proffessor of dermatology department
Other areas of specialty/work
Street address
Dermatology clinic, Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
Phone
+98 87 1328 5913
Fax
Email
dr_farokh.rad@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Farokh Rad
Position
Dermatologist, Assistant Proffessor of dermatology department
Other areas of specialty/work
Street address
Dermatology Clinic, Besat Hospital, Keshavarz St.
City
Sanandaj
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)