Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2019-12-13

Brief Summary

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This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus

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Detailed Description

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Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).

Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used

Study Groups

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Control group

Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.

Group Type ACTIVE_COMPARATOR

Topical pomegranate seeds and peel extracts

Intervention Type DRUG

Topical pomegranate seeds and peel extracts in the form of gel

Group S

Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.

Group Type EXPERIMENTAL

Topical pomegranate seeds and peel extracts

Intervention Type DRUG

Topical pomegranate seeds and peel extracts in the form of gel

Group P

Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.

Group Type EXPERIMENTAL

Topical pomegranate seeds and peel extracts

Intervention Type DRUG

Topical pomegranate seeds and peel extracts in the form of gel

Interventions

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Topical pomegranate seeds and peel extracts

Topical pomegranate seeds and peel extracts in the form of gel

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No