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

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
green tea tablets (Green tea extract 5:1) 200 mg
Triamcinolone Acetonide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

30 Years - 68 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Experimental

    Arm Label

    control subjects

    OLP and corticosteroid

    OLP and corticosteroid and green tea

    Arm Description

    10 systemically healthy control subjects taking no medication.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 29, 2014
    Last Updated
    September 25, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02329600
    Brief Title
    Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
    Official Title
    Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control subjects
    Arm Type
    No Intervention
    Arm Description
    10 systemically healthy control subjects taking no medication.
    Arm Title
    OLP and corticosteroid
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    OLP and corticosteroid and green tea
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    green tea tablets (Green tea extract 5:1) 200 mg
    Other Intervention Name(s)
    Green Tea Polyphenolic Fraction
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone Acetonide
    Other Intervention Name(s)
    Kenalog in orabase
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment
    Time Frame
    one month after treatment
    Secondary Outcome Measure Information:
    Title
    Salivary Total Oxidative Capacity
    Description
    total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment
    Time Frame
    one month after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    68 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noha Ghallab, M.D.
    Organizational Affiliation
    Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Enji Ahmed, M.D.
    Organizational Affiliation
    Lecturer of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ghada Nabil, B.D.S
    Organizational Affiliation
    Instructor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22582895
    Citation
    Agha-Hosseini F, Mirzaii-Dizgah I, Farmanbar N, Abdollahi M. Oxidative stress status and DNA damage in saliva of human subjects with oral lichen planus and oral squamous cell carcinoma. J Oral Pathol Med. 2012 Nov;41(10):736-40. doi: 10.1111/j.1600-0714.2012.01172.x. Epub 2012 May 15.
    Results Reference
    result
    PubMed Identifier
    12419687
    Citation
    Nakagawa T, Yokozawa T. Direct scavenging of nitric oxide and superoxide by green tea. Food Chem Toxicol. 2002 Dec;40(12):1745-50. doi: 10.1016/s0278-6915(02)00169-2.
    Results Reference
    result
    PubMed Identifier
    16225582
    Citation
    Sander CS, Cooper SM, Ali I, Dean D, Thiele JJ, Wojnarowska F. Decreased antioxidant enzyme expression and increased oxidative damage in erosive lichen planus of the vulva. BJOG. 2005 Nov;112(11):1572-5. doi: 10.1111/j.1471-0528.2005.00743.x.
    Results Reference
    result
    PubMed Identifier
    21827739
    Citation
    Singh BN, Shankar S, Srivastava RK. Green tea catechin, epigallocatechin-3-gallate (EGCG): mechanisms, perspectives and clinical applications. Biochem Pharmacol. 2011 Dec 15;82(12):1807-21. doi: 10.1016/j.bcp.2011.07.093. Epub 2011 Jul 30.
    Results Reference
    result
    PubMed Identifier
    22322481
    Citation
    Zhang J, Zhou G. Green tea consumption: an alternative approach to managing oral lichen planus. Inflamm Res. 2012 Jun;61(6):535-9. doi: 10.1007/s00011-012-0440-z. Epub 2012 Feb 10.
    Results Reference
    result

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

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