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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329600
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Noha Ayman Ghallab, Cairo University

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.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: green tea tablets (Green tea extract 5:1) 200 mg Drug: Triamcinolone Acetonide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Systemic Administration of Green Tea Polyphenols as a Supportive Antioxidant Agent in the Management of Oral Lichen Planus
Study Start Date : June 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
No Intervention: control subjects
10 systemically healthy control subjects taking no medication.
Active Comparator: OLP and corticosteroid
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.
Drug: Triamcinolone Acetonide
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 Name: Kenalog in orabase

Experimental: OLP and corticosteroid and green tea
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.
Drug: green tea tablets (Green tea extract 5:1) 200 mg
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 Name: Green Tea Polyphenolic Fraction

Drug: Triamcinolone Acetonide
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 Name: Kenalog in orabase




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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): NCT02329600


Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Noha Ghallab, M.D. Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Study Director: Enji Ahmed, M.D. Lecturer of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Principal Investigator: Ghada Nabil, B.D.S Instructor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Publications of Results:
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Responsible Party: Noha Ayman Ghallab, Associate Professor of periodontology and Oral Medicine, faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT02329600    
Other Study ID Numbers: polyphenol_TOC_OLP
First Posted: December 31, 2014    Key Record Dates
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action