Back to resultsTherapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
Primary Purpose
Atrophic Oral Lichen Planus, Erosive Oral Lichen Planus
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
placebo
Quercetin
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Oral Lichen Planus focused on measuring lichen planus, quercetin
Eligibility Criteria
Inclusion Criteria:
- confirmation of clinical diagnosis of Atrophic and erosive lichen planus by histological examination
- two weeks wash out periods after the last treatment
- having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in VAS Score
Exclusion Criteria:
- confirmation of dysplasia and malignancy in histologic examination
- confirmation of lichenoid reaction in histologic examination
- pregnancy and breast feeding
- using fluorokinolon and cyclosporin which interact with quercetin
Sites / Locations
- Mashhad university of Medical science, Research Center of oral and maxillofacial medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
quercetin
placebo
Arm Description
quercetin is one of flavonoids , and having therapeutical anti-inflammatory and antioxidant action
placebo capsul is produced with lactose for using in placebo/ control group.
Outcomes
Primary Outcome Measures
the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions.
In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the intensity of lesions weekly and any side effect of this Drug
Secondary Outcome Measures
Full Information
NCT ID
NCT01375101
First Posted
June 14, 2011
Last Updated
July 25, 2011
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01375101
Brief Title
Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. Alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids in order to decrease adverse drug reactions.
This study was conducted to evaluate the effect of quercetin on treatment of erosive -atrophic lesions of oral lichen planus (OLP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Oral Lichen Planus, Erosive Oral Lichen Planus
Keywords
lichen planus, quercetin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
quercetin
Arm Type
Active Comparator
Arm Description
quercetin is one of flavonoids , and having therapeutical anti-inflammatory and antioxidant action
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsul is produced with lactose for using in placebo/ control group.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
The patient is directed to use placebo capsule two times a day, ,until the one mouth
Intervention Type
Drug
Intervention Name(s)
Quercetin
Intervention Description
The patient is directed to digest quercetin hydrate capsule two times a day,until one mouth
Primary Outcome Measure Information:
Title
the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions.
Description
In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the intensity of lesions weekly and any side effect of this Drug
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmation of clinical diagnosis of Atrophic and erosive lichen planus by histological examination
two weeks wash out periods after the last treatment
having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in VAS Score
Exclusion Criteria:
confirmation of dysplasia and malignancy in histologic examination
confirmation of lichenoid reaction in histologic examination
pregnancy and breast feeding
using fluorokinolon and cyclosporin which interact with quercetin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
maryam amirchaghmaghi, assistant professor
Phone
0098-0511889201
Email
amirchakhmaghim@mums.ac.ir
Facility Information:
Facility Name
Mashhad university of Medical science, Research Center of oral and maxillofacial medicine
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
maryam amirchaghmaghi, assistant professor
Phone
0098-0511882901
Email
amirchakhmaghim@mums.ac.ir
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
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