Objective: The therapeutic effect of Nigella sativa Linn extract has been widely proved of ancient to now. It is suggested that an herbal product from Nigella sativa extract in the form of a gel may be beneficial in treatment of RAS. The aim of this study is to evaluate the efficacy of a gel prepared from Nigella sativa Linn extract on the clinical management of RAS patients. Design: The present study is a randomized, double-blind, and placebo-controlled study that is conducted on 56 patients diagnosed to have aphtatous ulcers. Setting and conduct: 28 patients were advised to apply thymoquinone gel twice times a day for one month and the other 28 patients were given placebo gel for the same duration. Efficacy evaluations are made on the four times during one-month period. Patient exclusion criteria: These include: Drug usage or any treatment occurring before dental treatment; systemic diseases; hypersensitivity history; smoking habits or alcoholism; pregnancy and lactation; orthodontic instruments. Primary outcome measure are duration of healing, size of lesion, pain in lesion and erythema. Data were analyzed using the repeated measures ANOVA, paired and independent t-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100914106N5
Registration date:2017-09-12, 1396/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-12, 1396/06/21
Registrant information
Name
Reza Tahvilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6482
Email address
rtahvilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Science
Expected recruitment start date
2017-08-21, 1396/05/30
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation an oral gel-made from thymoquinone (TQ), and clinical study investigating the efficacy of it on patients with aphtha
Public title
Preparation an oral gel-made from thymoquinone (TQ), and clinical study investigating the efficacy of it on patients with aphtha
Purpose
Treatment
Inclusion/Exclusion criteria
Patient inclusion criteria include: possessing aphtatous ulcer; patients without systemic diseases, hypersensitivity history; smoking habits or alcoholism; pregnancy and lactation; orthodontic instruments.
Patient exclusion criteria include: Drug usage or any treatment occurring before dental treatment.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Science
Street address
Central building, Beheshti Blvd, Kermanshah University of Medical Science update Kermanshah
City
Kermanshah
Postal code
6715847141
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
KUMS.REC.1396.188
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
duration of healing
Timepoint
healing measurement will be done twice per month
Method of measurement
quantitative and qualitative assays
2
Description
size of lesion
Timepoint
size of lesion measurement will be done twice per month
Method of measurement
quantitative and qualitative assays
3
Description
pain in lesion
Timepoint
pain measurement in lesion will be done twice per month
Method of measurement
quantitative and qualitative assays
4
Description
erythema
Timepoint
erythema evaluation will be done twice per month
Method of measurement
quantitative and qualitative assays
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: In this group,28 patients will be received 10% Pomegranate gel. The period for use of the product will be twice a day for a period of one month.
Category
Treatment - Drugs
2
Description
Control group: 28 patients will be received placebo. The placebo gels contain all the components of the intervention group gel except for the pomegranate extract; they actually receive the placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic
Full name of responsible person
Reza Tahvilian
Street address
School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Science
Full name of responsible person
Reza Tahvilian
Street address
Central building, Beheshti Blvd, Kermanshah University of Medical Science
City
Kermanshah
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, Kermanshah University of Medical Science
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
School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran
Full name of responsible person
Reza Tahvilian
Position
Ph.D
Other areas of specialty/work
Street address
School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3427 6489
Fax
Email
rtahvilian@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran
Full name of responsible person
Reza Tahvilian
Position
Ph.D
Other areas of specialty/work
Street address
School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3427 6489
Fax
Email
rtahvilian@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran
Full name of responsible person
Fereshte Bagheri
Position
MSc. of Biotechnology
Other areas of specialty/work
Street address
School of Pharmacy,Kermanshah University of Medical Sciences (KUMS) Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3427 6489
Fax
Email
f.bagheri2016@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)