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

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329600
• Other study ID #: polyphenol_TOC_OLP
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2014
• Last updated: December 30, 2014
• Start date: June 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 68 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (5)

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.1600-0714.2 — View Citation

Nakagawa T, Yokozawa T. Direct scavenging of nitric oxide and superoxide by green tea. Food Chem Toxicol. 2002 Dec;40(12):1745-50. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	pain was assessed by visual analogue scale (1-10) at baseline before treatment and 1 month after treatment	baseline and one month	No
Secondary	salivary total oxidative capacity	total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay at baseline before treatment and 1 month after treatment	baseline and one month	No