The aim of the present study is to formulate adhesive mucosal gel containing licorice nanoniosomes and its clinical evaluation in the treatment of oral ulcers.
Design
A randomized controlled clinical trial with a parallel group
Settings and conduct
The present study is a two-group clinical trial that will be performed on 40 patients with oral ulcers in Hamedan in 2020.Intervention Procedure will receive the gel mouthwash of Niosomal licorice extract Three times a day, half an hour before meals for a week.
Control group: Initial oral care, as well as three times a day, half an hour before meals for one week, will receive the licorice extract mouthwash gel.
Participants/Inclusion and exclusion criteria
Age group between 18 and 65 years
Definite diagnosis of mild to moderate pest or mucositis by a dental specialist
Absence of other skin diseases such as psoriasis
No infection in the affected area
Intervention groups
Intervention Procedure will receive the gel mouthwash of Niosomal licorice extract Three times a day, half an hour before meals for a week, .
Control group: Initial oral care, as well as three times a day, half an hour before meals for one week, will receive the licorice extract mouthwash gel.
Main outcome variables
Incidence and severity of oral ulcers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046143N1
Registration date:2020-01-26, 1398/11/06
Registration timing:prospective
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Seyed Yaser Vafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3426 6353
Email address
y.vafaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and clinical evaluation of muccoadhesive gel containing licorice based nanoniosomes for treatment of oral ulcers
Public title
Formulation and clinical evaluation of muccoadhesive gel containing licorice based nanoniosomes for treatment of oral ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of mild to moderate aphtous or mucositis by a dental specialist
Absence of other skin diseases such as psoriasis
No infection in the affected area
Exclusion criteria:
Diabetic patients with heart failure
Pregnancy during the study
Side effects that are not tolerated by the patient
Immune deficiency
Malignant diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications will be perfectly the same in the two groups. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.UMSHA.REC.1398.861
Health conditions studied
1
Description of health condition studied
oral ulcers
ICD-10 code
K12
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
Incidence and severity of oral ulcers
Timepoint
Before and up to a week after the intervention
Method of measurement
World Health Organization Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive niosomal mouthwash Licorice extract three times each half hour before meals for one week.
Category
N/A
2
Description
Control group: Primary oral care, as well as three times a day, half an hour before meals for a week, will receive a Licorice extract mouthwash gel.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
Seyed Yaser Vafaei
Street address
Hamadan, Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 1590
Email
y.vafaei@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0717
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Yaser Vafaei
Position
Assistant Prophessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 1590
Email
y.vafaei@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Yaser Vafaei
Position
Assistant Prophessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hamadan, Shahid Fahmideh Ave., Hamadan University of Medical Sciences
City
hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1590
Email
y.vafaei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Yaser Vafaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
ُFaculty of pharmacy, Hamadan university of medical science, Shahid Fahmideh ave, Hamadan
City
همدان
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3426 6353
Fax
Email
y.vafaei@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available