Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus
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|ClinicalTrials.gov Identifier: NCT03415165|
Recruitment Status : Unknown
Verified January 2018 by Esraa Magdy, Cairo University.
Recruitment status was: Recruiting
First Posted : January 30, 2018
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oral Lichen Planus||Drug: green tea buccal tablet Drug: Corticosteroids Topical||Early Phase 1|
- Each patient was informed about the detailed procedure, and educated about benefits of the treatment, the known side effects and follow-up appointments needed. After that, each subject participating in the study signed an informed written consent form.
- 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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of 200mg and 300mg Concentrates of Green Tea Polyphenols Using Buccal Tablets Versus Topical Application of Corticosteroids in Treatment of Patients With Symptomic Oral Lichen Planus Randomized Clinical Trial|
|Actual Study Start Date :||January 3, 2018|
|Estimated Primary Completion Date :||January 30, 2019|
|Estimated Study Completion Date :||January 30, 2019|
Active Comparator: green tea buccal tablet
buccal tablet 3 times aday
Drug: green tea buccal tablet
buccal tablet for 8 hrs 3 times aday
Other Name: catechines
Sham Comparator: corticosteroids topical
topical steroids 3 times aday
Drug: Corticosteroids Topical
kenacort in orabase 4 times aday
Other Name: local corticosteroids
- size of the lesion [ Time Frame: 12 weeks ]the shape and the measurement of its size
- visual analogue score [ Time Frame: 12 weeks ]pain score from 0 to 10
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415165
|Contact: EMagdy baligh, firstname.lastname@example.org|
|Contact: esraa baligh, email@example.com|
|Cairo, Egypt, 00202|
|Contact: cairo university firstname.lastname@example.org|
|Contact: cairo university|
|Study Chair:||cairo university||cu|