Phase 3 N=40 Randomized Single-blind Treatment

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

Oral Lichen Planus

Bottom Line

View on ClinicalTrials.gov: NCT02329600 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2016

Primary outcome: Primary: Pain — 0; 4; 4.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: green tea tablets (Green tea extract 5:1) 200 mg (Drug); Triamcinolone Acetonide (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Cairo University
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain	0; 4; 4.4	—
SECONDARY Salivary Total Oxidative Capacity	6.37; 58.41; 23.27	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02329600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.