Lichen planus (LP), a relatively common mucocutaneous disease, has unknown etiology and potential for malignant transformation. However several researches have been done, but there isn’t any standard treatment yet and current methods have many side effects.
Among LP related immunologic and inflammatory factors, one issue which recently catches researchers’ attention is cytokine “interleukin-17”(IL-17) ,whereas its importance has been shown in several autoimmune diseases.
ProPolis, a natural product of honey bees, has been described to have ability of control and reduction of IL-17, and its effectiveness has been investigated in animal studies.
In this study, 30 patients with ulcerative oral LP (clinically and histopathologically diagnosed) whome referred to oral medicine department of Tabriz dental faculty were subjected. Serum level of IL-17 will be analyzed in 5cc of blood sample of these patients by ELISA method in a specific kit.
During first one month period, patients will be take ProPolis capsules (500mg/daily). Then blood sampling and leveling of IL-17 will be repeated.
We will obtain fresh ProPolis from Sabalan Mountains which will be extacted by alcohol solvent at pharmacology faculty of Tabriz.
Results will be analyzed by descriptive statistics( standard deviation-mean )and paired sample t-test or its non parametric equivalent(wilcoxon test ) by using of spss 16 soft ware.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010111976N1
Registration date:2013-02-10, 1391/11/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-10, 1391/11/22
Registrant information
Name
Ali Taghavi Zenuz
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
taghavia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2013-02-04, 1391/11/16
Expected recruitment end date
2013-02-14, 1391/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of propolis use on blood level of il-17 in ulcerative oral lichen planus patients
Public title
Effect of propolis use on blood level of il-17 in ulcerative oral lichen planus patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with ulcerative oral lichen planus with clinical manifestations and histopathological criteria including: 1-Areas of hyper parkeratosis or hyper orthokeratosis, often with thickening of granular cell layer and saw-toothd appearance to the retepegs. 2-liquefaction degeneration or necrosis of basal cell layer.
3-sub epithelial band like infiltration of T lymphocyte and macrophage.
Exclusion criteria: any factor that cause lichenoid reaction like as drug use or presence of amalgam restoration adjucent to lesions; any disease that suppresses immune system,such as HIV or Iv drug abuse,and any disease in which doing biopsy has medical complications; use of drug during one month ago for treatment of olp or use of antibiotic or corticosteroid or any drug that can suppress lymphocyte activity(for confidence that drugs don't change serum level of il-17); report of dysplasia or malignancy in patients pathology; history of dermal or digestive hypersensitivity to propolis; unwillingness to participate in study at any stages and report of side effects from patients or researchers.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of tabriz university of medical sciences
Street address
Tabriz-Golgasht street-university of medical sciences -central building no 2-3th floor.
City
Tabriz
Postal code
5166614713
Approval date
2013-01-07, 1391/10/18
Ethics committee reference number
91168
Health conditions studied
1
Description of health condition studied
oral lichen planus
ICD-10 code
L-43
ICD-10 code description
lichen planus
Primary outcomes
1
Description
serum level of il-17
Timepoint
At the begining of research-one month later
Method of measurement
Elisa kit (ebio science company)
Secondary outcomes
1
Description
size of lesions
Timepoint
At the beigining of the research-one month later
Method of measurement
Mesurment of lesion size at the begining of research with digital colis and then mark the changes by researcher in future follwing.
2
Description
Pain and burning sensation
Timepoint
At the beigining of the research-one month later
Method of measurement
VAS scale
Intervention groups
1
Description
propolis capsule 500 mg daily for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral Medicine Department- Dental Faculty-Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Taghavi Zenuz
Street address
Tabriz- Golgasht sreet- Dental School- Oral Medicine Department
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Seied Kazem Shakori
Street address
Tabriz- Golgasht street- Tabriz University of Medical Sciences- Central building no 2- 3th floor
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Tabriz 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
Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Tavakoli Ataabadi
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Tabriz- Golgasht street- Faculty of Dentistry- Oral Medicine Department
City
Tabriz
Postal code
5166614713
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
drtavakolireza.dds@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Taghavi Zonuz
Position
Associated professor of oral medicine
Other areas of specialty/work
Street address
Tabriz- Golgasht street- Faculty of Dentistry- Oral Medicine Department
City
Tabriz
Postal code
5166614713
Phone
+98 41 1335 5965
Fax
+98 41 1335 5966
Email
taghavia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Dr Reza Tavakoli AtaabAdi
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Tabriz- Golgasht street- Dental Faculty- Oral Medicine Department
City
Tabriz
Postal code
5166614713
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
drtavakolireza.dds@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)