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
  Purpose

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).


Condition Intervention Phase
Atrophic Oral Lichen Planus
Erosive Oral Lichen Planus
Drug: placebo
Drug: Quercetin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: quercetin
quercetin is one of flavonoids , and having therapeutical anti-inflammatory and antioxidant action
Drug: Quercetin
The patient is directed to digest quercetin hydrate capsule two times a day,until one mouth
Placebo Comparator: placebo
placebo capsul is produced with lactose for using in placebo/ control group.
Drug: placebo
The patient is directed to use placebo capsule two times a day, ,until the one mouth

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375101

Contacts
Contact: maryam amirchaghmaghi, assistant professor 0098-0511889201 amirchakhmaghim@mums.ac.ir

Locations
Iran, Islamic Republic of
Mashhad university of Medical science, Research Center of oral and maxillofacial medicine Recruiting
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Contact: maryam amirchaghmaghi, assistant professor    0098-0511882901    amirchakhmaghim@mums.ac.ir   
Sponsors and Collaborators
Mashhad University of Medical Sciences
  More Information

No publications provided

Responsible Party: maryam amirchaghmaghi, assistant professor of oral medicine department- mashhad medical school
ClinicalTrials.gov Identifier: NCT01375101     History of Changes
Other Study ID Numbers: 88705
Study First Received: June 14, 2011
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mashhad University of Medical Sciences:
lichen planus
quercetin

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Atrophy
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Pathological Conditions, Anatomical
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014