The purpose of this study is to evaluate the therapeutic effect of curcumin on erosive and atrophic OLP. Here, a randomized, double blind (patients and practitioners), phase II and unicentered clinical trial is conducted with a total of 25 OLP patients. Patients are recruited from the Department of Oral Medicine, Mashhad Dental School, with clinical signs of erosive and atrophic OLP which has been confirmed by clinical or histopathological examinations. Patients are randomly divided into two groups (case and control groups) Randomization is done using a computer-generated random number table. The patients of both groups receive Dexamethasone and Nystatin Mouthwash three times a day as a routine treatment. The case group receives 4 curcumin tablets (500 mg) per day for a period of 4 weeks, whereas the control group receives placebo tablets. Patients are evaluated on days 14 and 28. Pain and burning sensation are measured based on the Visual analogue scale, and the Thongprasom index is used for clinical improvement and healing. The effect of curcumin on erosive and atrophic OLP are compared in these two groups of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121425498N1
Registration date:2016-01-15, 1394/10/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-15, 1394/10/25
Registrant information
Name
Ala Ghazi
Name of organization / entity
Mashhad University of Medical Sciences, School of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
ghazia921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Scienses
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of curcumin in the treatment of oral lichen planus: a double blind clinical trial
Public title
Curcumin efficacy on oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with clinical signs of erosive and atrophic OLP confirmed by clinical or histopathological examination were included in our study.
The exclusion criteria: pregnancy; lactation; current use of anticoagulants or antiplatelet agents; currant orthodontic treatment; history of gastric ulcers; duodenal ulcers; gallstones; hepatic diseases; any existing malignancy or viral infection in mouth; receiving any topical treatment for OLP in the past 2 weeks or any systemic treatment for OLP in the past 4 weeks; use of azathioprine, cyclosporine or receiving PUVA, UVA or UVB in the last month; a history of allergy to corticosteroids or curcumin.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
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 Mashhad University of Medical Scienses
Street address
Mashhad University of Medical Sciences,Faculty of Dentistry
City
Mashhad
Postal code
Approval date
2012-10-21, 1391/07/30
Ethics committee reference number
901063
Health conditions studied
1
Description of health condition studied
Lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
Lichen planus improvement
Timepoint
On days 14 and 28
Method of measurement
Thongprasom index
Secondary outcomes
1
Description
Pain and burning sensation
Timepoint
On days 14 and 28
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention group: curcumin tablets at a dose of 2000 mg/day for a period of 4 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo for a period of 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Ala Ghazi
Street address
Department of Oral Medicine, School of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blv
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Azam S. Madani
Street address
Department of Oral Medicine, School of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blv
City
Mashhad
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, Mashhad 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
Mashhad Dental School
Full name of responsible person
Dr Maryam Amirchakhmaghi
Position
Associate Professor of Oral Medicine
Other areas of specialty/work
Street address
Department of Oral Medicine, School of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blv
City
Mashhad
Postal code
911735984
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
amirchakhmaghim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Dental School
Full name of responsible person
Dr Atessa Pakfetrat
Position
Professor of Oral Medicine
Other areas of specialty/work
Street address
Department of Oral Medicine, School of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blv
City
Mashhad
Postal code
911735984
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
pakfetrata@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Dental School
Full name of responsible person
Dr Ala Ghazi
Position
Assistant Professor of Oral Medicine
Other areas of specialty/work
Street address
Department of Oral Medicine, School of Dentistry, Mashhad University of Medical Sciences, Vakilabad Blv
City
Mashhad
Postal code
911735984
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
ghazia921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)