Comparison of the effectiveness of Glycyrrhiza glabra solution with Diphenhydramine Elixir in the management of pain and duration of Recurrent Aphthous Stomatitis
Comparison of the efficacy of Glycyrrhiza glabra in Diphenhydramine solution with Diphenhydramine Elixir in the management of Recurrent aphthous Stomatitis
Design
Clinical trials with parallel , double -blind, randomized groups
Settings and conduct
This study is conducted in Birjand, and in this study,major researcher, participants and data collectors are kept blind.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
Patients with RAS with duration of 1 day of begining of their symtoms
Exit criteria:
1. Use of systemic Aphthous treatment (over the past three months) and topical treatment during the procedure
2. Atypical Aphthous cases and cases suspected of Behcet's syndrome, inflammatory bowel disease, and ...
3. Pregnant or lactating women
4. Patient with Diabetes
5. High blood pressure
6. Duration of the Aphthous more than one day
7. The patients who did not sign the letter of informed consent
Intervention groups
Patients with RAS in Birjand
Main outcome variables
1. If the licorice extract was effective, it will be used as a treatment for recurrent oral wounds
2. If the licorice extract was effective, it will be used in other recurrent oral ulcers, including in patients with Behcet's syndrome, or oral ulcers with inflammatory bowel diseases (Crohn's disease and ulcerative colitis).
3. If the licorice extract was effective, It will be used in the treatment of mucositis due to radiation therapy or chemotherapy for cancers, which due to severe symptoms, occasionally lead to changes or even discontinuation of treatment regimens.
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180407039213N1
Registration date:2018-06-29, 1397/04/08
Registration timing:registered_while_recruiting
Last update:2018-06-29, 1397/04/08
Update count:0
Registration date
2018-06-29, 1397/04/08
Registrant information
Name
Neda Asadi mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4724 5342
Email address
n.asadi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Glycyrrhiza glabra solution with Diphenhydramine Elixir in the management of pain and duration of Recurrent Aphthous Stomatitis
Public title
The effectiveness of licorice solution in Recurrent Aphthous Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with RAS symptoms for less than 1 day
Exclusion criteria:
The patients who did not sign the letter of informed consent
Patient with hypertension (greater than 80/130)
Use of systemic aphthous treatment (over the past three months) and topical treatment during the procedure
Atypical aphthous cases and cases suspected of Behcet's syndrome, inflammatory bowel disease.
Pregnant or lactating women
Patients with Diabetes
Patients with RAS symptoms for more than 1 day
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization by sealed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, major researcher, data collectors were kept blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Dentistry faculty, Birjand University of Medical Sciences, Ghaffari street, Birjand, Iran
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
Ir.bums.REC.1396.338
Health conditions studied
1
Description of health condition studied
Recurrent Aphthous Stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Improvement of pain and duration of Recurrent Aphthous Stomatitis symptoms
Timepoint
Measurement of pain intensity and healing of wound in second, third, and fifth days of intervention
Method of measurement
Visual Analogue Scale (VAS) to measure pain and physical examination to detect wound healing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with RAS gargle licorice 5% in Diphenhydramine every 6 hours (3 ml for 3 minutes) until improvement
Category
Treatment - Drugs
2
Description
Control group: RAS patients gargle Diphenhydramine without licorice every 6 hours (3 ml for 3 minutes) until improvement
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand University of Medical Sciences
Full name of responsible person
Neda Asadi Mehr
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
n.asadi@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Kazemi Tooba
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
n.asadi@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Akbari Narjes
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
narges-akbare4021@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Akbari Narjes
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
narges-akbare4021@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Akbari Narjes
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghaffari
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
narges-akbare4012@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because its not mandatory yet
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Publication of a paper in academic journals
When the data will become available and for how long
From 2019
To whom data/document is available
Anyone who wishes to access the data.
Under which criteria data/document could be used
To achieve the aims in the approved
proposal.
From where data/document is obtainable
Proposal may be submitted up to 24
months following article publication.
What processes are involved for a request to access data/document
Proposal will be available up to 24
months following article publication.