Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
This study is currently recruiting participants.
Verified July 2011 by Mashhad University of Medical Sciences
Sponsor:
Mashhad University of Medical Sciences
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Atrophy Lichen Planus, Oral Lichenoid Eruptions Skin Diseases, Papulosquamous Skin Diseases Pathological Conditions, Anatomical Mouth Diseases |
Stomatognathic Diseases Quercetin Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013