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Completed

NCT Number: NCT02329600

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

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.

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

30 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.

Other names: Green Tea Polyphenolic Fraction

Triamcinolone Acetonide

Drug

topical corticosteroids (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

Other names: Kenalog in orabase

Primary outcomes

  1. Pain

    Time frame: one month after treatment

    pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment

Secondary outcomes

  1. Salivary Total Oxidative Capacity

    Time frame: one month after treatment

    total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 31, 2014
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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