The aim of this study is evaluating the effect of somaq on size and pain of patients with recurrent aphtus stomatitis.
Design
22 patients with active RAS will be divided randomly (block randomization) to 2 experimental and control group.
Settings and conduct
This randomized phase 2 clinical trial will be done in 2017 on the patients who will be referred to Shiraz Dental School for their RAS.
In experimental group 11 patients will receive somaq pills but in the control group oral paste triadent0.1 three times in a day will be used by 11participents. In the experimental group the patients will use 3pills daily for 7days.The researcher will evaluate VAS (visual analogue scale) of participants before and after using pills (on day 0,1,2,3,4,5,6,7). The size of a specific ulcer in each patient also will be measured by graded tongue blade on day 0,1,2,3,4,5,6,7. The healing process will be evaluated by measuring oral ulcer size and patient pain will be studied by VAS.
Participants/Inclusion and exclusion criteria
The patient with RAS since less than 72h will be enrolled in this research. They should have not use any topical or oral corticosteroid since a month before. Also they should not use any analgesic mouthwash or systemic analgesic since 3 days before this evaluation. The participant who will sign the written consent form will be recruited.
Intervention groups
In experimental group 11 patients will receive somaq pills but in the control group oral paste triadent 0.1 three times in a day will be used by 11participents. In the experimental group the patients will use 3 pills daily for 7days.
Main outcome variables
level of pain; size of lesion
General information
Reason for update
Acronym
recurrent aphtus stomatitis (RAS)
IRCT registration information
IRCT registration number:IRCT20120101008585N4
Registration date:2017-12-24, 1396/10/03
Registration timing:registered_while_recruiting
Last update:2017-12-24, 1396/10/03
Update count:0
Registration date
2017-12-24, 1396/10/03
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Rhus Coriaria on pain and size of oral recurrent aphtus stomatitis in patients reffered to Shiraz Dental School
Public title
Evaluation the effect of Rhus Coriaria on oral aphtus stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having recurrent aphtus stomatis
not using other routine prescribed medication for RAS during evaluation
less than 72 hour from emerging of the lesion
not using systemic or topical corticosteroid since 1 month ago
Patient more than 6 years old
Exclusion criteria:
patients with other diseases related to behcet , crohn disease, rheiter syndrome or any other inflammatory disease
using analgesic mouthwash or systemic analgesia since 3 days ago
pregnant women
Age
From 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Unit of randomization is individual
Tools used in randomization is flipping a coin.
head is considered as control and tail as intervention group.
allocation concealment is carring out
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Mehr street, Ghasrdasht Ave.
City
Shiraz
Province
Fars
Postal code
71959-44315
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.SUMS.REC.1396.121
Health conditions studied
1
Description of health condition studied
recurrent aphtus stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
pain intensity
Timepoint
day 0,1,2,3,4,5,6,7
Method of measurement
Visual Analogue Scale
2
Description
oral lesion size
Timepoint
day 0,1,2,3,,4,5,6,7
Method of measurement
measuring with ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In experimental group the patients will receive somaq pills. The patients will use 3pills daily for 7days. By inserting the pill on the lesion, the pill itself will attach to the oral ulcer for some minute. The patient should hold this pill until it solves completely. The pills are 0.9cm in diameter. The pills was prepared by Shiraz Pharmacy Faculty. The compositions of this pill is 50% avicel, 0.2% magnesium Stearate and the remaining is somaq.
Category
Treatment - Drugs
2
Description
Control group: In the control group oral paste triadent 3 times in a day will be used. Teriadent is triamcinolone acetonide 0.1% manufactured by Raha pharma.co, Isfahan, Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz dental school
Full name of responsible person
Fatemeh Lavaee
Street address
Mehr street, Ghasrdasht Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Mehr street, Ghasrdasht Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3212 2438
Email
lavaeef@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mehr street, Ghasrdasht Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mehr street, Ghasrdasht Ave.
City
Shraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mehr street, Ghasrdasht Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
data related to primary outcome of pain level and size of lesion
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
people working in businesses
Under which criteria data/document could be used
Statistical analysis on data is allowed.
The applicant should email a request containing his request and the reason of his request. He should introduce himself. the data will send to him.
From where data/document is obtainable
call Dr. Fatemeh Lavaee via lavaeef@sums.ac.ir, fatemeh.lavaee@gmail.com
Telephone: 00989177029159
What processes are involved for a request to access data/document
The applicant should email a request containing his request and the reason of his request. He should introduce himself. the data will send to him.