Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Mashhad University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01375101
First received: June 14, 2011
Last updated: July 25, 2011
Last verified: July 2011

June 14, 2011
July 25, 2011
April 2010
September 2011   (final data collection date for primary outcome measure)
the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01375101 on ClinicalTrials.gov Archive Site
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Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
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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).

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Atrophic Oral Lichen Planus
  • Erosive Oral Lichen Planus
  • Drug: placebo
    The patient is directed to use placebo capsule two times a day, ,until the one mouth
  • Drug: Quercetin
    The patient is directed to digest quercetin hydrate capsule two times a day,until one mouth
  • Active Comparator: quercetin
    quercetin is one of flavonoids , and having therapeutical anti-inflammatory and antioxidant action
    Intervention: Drug: Quercetin
  • Placebo Comparator: placebo
    placebo capsul is produced with lactose for using in placebo/ control group.
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
12 Years to 60 Years
No
Contact: maryam amirchaghmaghi, assistant professor 0098-0511889201 amirchakhmaghim@mums.ac.ir
Iran, Islamic Republic of
 
NCT01375101
88705
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maryam amirchaghmaghi, assistant professor of oral medicine department- mashhad medical school
Mashhad University of Medical Sciences
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Mashhad University of Medical Sciences
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP