Comparison of five doses of mucoadhesive prednisolone (0.5, 1, 2.5, 5, 10mg) in treatment of recurrent aphthous stomatitis: A Triple blind randomized clinical trial
To compare five doses of mucoadhesive prednisolone (0.5, 1, 2.5, 5, 10mg) in treatment of recurrent aphthous stomatitis (RAS). 225 patients aged 18-15 yrs with at least 3 months presentation of RAS and at least one breakout per month that have no other diseases such as behcet syndrome, DM, hepatic diseases etc. will be recruited to be treated with one of the five different doses of mucoadhesive prednisolone. The patients will put the mucoadhesive patches on their aphthous ulcers every 12 hours each time for 30 minutes (according to the protocol). The groups will be measured for size and number of ulcers, severity of pain and burning sensation, before the treatment and then every day for 7 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110037710N1
Registration date:2012-07-22, 1391/05/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-22, 1391/05/01
Registrant information
Name
Farzad Gheshlaghi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 7823
Email address
gheshlaghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of five doses of mucoadhesive prednisolone (0.5, 1, 2.5, 5, 10mg) in treatment of recurrent aphthous stomatitis: A Triple blind randomized clinical trial
Public title
Comparison of five doses of mucoadhesive prednisolone in treatment of recurrent aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People aged 18-45 years; at least 3 months presentation of RAS; at least 1 breakout of disease each month; not responding to any medication. Exclusion criteria: systemic disease such as: diabetes, liver disease, Gastro-intestinal disease, kidney disease, Rheumatologic disease or behcet syndrome; people with teched CBC lab data; patients who take immunosupressive / immunomodulant medicine.
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
225
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee, Isfahan University of Medical Sciences
Street address
No 3, 4th department of Gostaresh departments, Isfahan university of medical sciences, Hazarjarib st.
City
ISfahan
Postal code
Approval date
2011-03-21, 1390/01/01
Ethics committee reference number
190164
Health conditions studied
1
Description of health condition studied
Recurrent Aphthous Stomatitis
ICD-10 code
K12
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
number of ulcers
Timepoint
before intervention and then every 24 hour for 6 days
Method of measurement
observation
2
Description
size of ulcers
Timepoint
before intervention and then every 24 hour for 7 days
Method of measurement
with caliper
3
Description
Severity of pain and burning sensation
Timepoint
before intervention and then every 24 hour for 7 days
Method of measurement
Visual Analogue Scale Score
Secondary outcomes
empty
Intervention groups
1
Description
3rd group :
Intervention : the patients will put mucoadhesive prednisolone 2.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.
Category
Treatment - Drugs
2
Description
1st group :
Intervention : the patients will put mucoadhesive prednisolone 0.5 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.
Category
Treatment - Drugs
3
Description
2nd group :
Intervention : the patients will put mucoadhesive prednisolone 1.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.
Category
Treatment - Drugs
4
Description
4th group :
Intervention : the patients will put mucoadhesive prednisolone 5.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.
Category
Treatment - Drugs
5
Description
5th group :
Intervention : the patients will put mucoadhesive prednisolone 10.0 mg on their ulcers every 12 hours and each time for 30 minutes. The treatment continues for 7 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin clinic -super specialty Alzahra hospital
Full name of responsible person
Street address
City
ISfahan
2
Recruitment center
Name of recruitment center
Skin clinic, super specialty Nur-ali Asqar hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of medical sciences
Full name of responsible person
Dr. Peiman Adibi
Street address
Hazarjarib st.
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Farzad Gheshlaghi
Position
Forensic Medicine
Other areas of specialty/work
Street address
No 4, Behesht-ain alley, south Mollasadra st.
City
Isfahan
Postal code
Phone
+98 31 1669 7823
Fax
Email
gheshlaghi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. farzad Gheshlaghi
Position
Forensic Medicine
Other areas of specialty/work
Street address
No 4, Behesht-ain alley, south Mollasadra st.
City
Isfahan
Postal code
Phone
+98 31 1669 7823
Fax
Email
gheshlaghi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Dr. Farzad Gheshlaghi
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
Fax
Email
gheshlaghi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)