Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus
NCT ID: NCT03415165
Last Updated: 2018-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2018-01-03
2019-01-30
Brief Summary
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Detailed Description
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* Subjects were given freedom to leave the study at any time when they need to. Group A (Experimental group) 200 mg green tea
Where patients in this group will receive a buccal tablet containing 200 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.
Preparation of buccal tablets : Mucoahesive buccal tablets is prepared by a direct compression procedure. Various batches are prepared by varying the chitosan:drug ratio to identify the most effective formulation. The mucoadhesive drug/polymer mixture is prepared by homogeneous mixing of the drug with chitosan , secondary polymer, and D-mannitol, in a glass mortar for 15 min. Then, Mg stearate will be added and mixed for 5 min .The mixture is compressed using a tablet machine (Type EK: O.Erweka apparatus, Frankfurt, Germany) using flat-tip punches and dies with 8-mm-diameter. Each tablet weighed 212 mg with a thickness of 3.1 mm.( Darwish and Elmeshad,2009)
Group B (Experimental group) 300 mg green tea
Where patients in this group will receive a buccal tablet containing 300 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.
Group C (Control group) corticosteroid group:
Where patients are treated with topical corticosteroids 1 mg/g Triamcinolone acetonide (Kenacort-A orabase 20 G Pomad: Deva dermatological product,Turkey) applied topically 4 times a day i.e. following each meal and at bed time for four weeks .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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green tea buccal tablet
buccal tablet 3 times aday
green tea buccal tablet
buccal tablet for 8 hrs 3 times aday
corticosteroids topical
topical steroids 3 times aday
Corticosteroids Topical
kenacort in orabase 4 times aday
Interventions
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green tea buccal tablet
buccal tablet for 8 hrs 3 times aday
Corticosteroids Topical
kenacort in orabase 4 times aday
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* OLP lesions with the diagnosis confirmed both clinically and histopathologically.
* Clinical score higher than 3.
* Disease duration of more than 2 months.
* Absence of dysplasia in histological section
Exclusion Criteria
* Pregnant or breast-feeding women,
* Immuno-deficiency diseases.
* Current malignancy or malignancy in history.
* Concomitant treatment potentially effective on OLP within the previous 2 months such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs.
* Severe or recurrent infections.
* Lichenoid reaction.
* Patients presents with skin lesions which may require systemic corticosteroid therapy.
17 Years
80 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Esraa Magdy
princible investigator EMagdy
Principal Investigators
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cairo university
Role: STUDY_CHAIR
cu
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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cairo university
Role: backup
Other Identifiers
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161187
Identifier Type: -
Identifier Source: org_study_id
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