Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Oral Lichen Planus

Treatments: Drug: Triamcinolone Acetonide; Drug: green tea tablets (Green tea extract 5:1) 200 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02329600

polyphenol_TOC_OLP

Details and patient eligibility

About

The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.

Full description

This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy control subjects not receiving medication.

Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.

Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.

Enrollment: 40 patients

Sex: All

Ages: 30 to 68 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients presented with painful oral lichen planus lesions
• Free of any visible oral lesions other than oral lichen planus
• Free of any systemic diseases

Exclusion criteria

• Topical treatment or systemic therapy of OLP for one month before starting the study
• Pregnant or breast feeding women
• Smokers
• Use of corticosteroids or other immunosuppressive drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

control subjects

No Intervention group

Description:

10 systemically healthy control subjects taking no medication.

OLP and corticosteroid

Active Comparator group

Description:

15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.

Treatment:

Drug: Triamcinolone Acetonide

OLP and corticosteroid and green tea

Experimental group

Description:

15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.

Treatment:

Drug: green tea tablets (Green tea extract 5:1) 200 mg

Drug: Triamcinolone Acetonide