Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus

NCT ID: NCT03793634

Last Updated: 2019-01-04

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-03-01

Brief Summary

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Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.

Detailed Description

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Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that affects skin and any mucous membrane particularly oral mucosa.The patient complains of burning sensation, pain; interference with eating, swallowing and speech leading to worsening of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.

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

SINGLE

Outcome Assessors
The supervisor(AA) will be blind. The principle investigator(EN) will supply the patient with the treatment.

The supervisor (AA) will assess the clinical parameters before treatment , between visits and at the end of the treatment.

Statistician will be blind. Double - blind study.

Study Groups

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topical chamomile

herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.

Group Type EXPERIMENTAL

topical chamomile

Intervention Type DRUG

herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect

Topical Triamcinolone Acetonide

topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.

Group Type ACTIVE_COMPARATOR

topical chamomile

Intervention Type DRUG

herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect

Interventions

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topical chamomile

herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptomatic OLP.
* Patients with no history of taking corticosteroids for the last 6 months.
* Patients who agree to take medication.
* Medically free

Exclusion Criteria

* Patients with oral lesions other than OLP.
* Lichenoid reaction .
* Pregnant females and lactation.
* Smokers
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Nashat

11 saraya st - manial - cairo

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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chamomile in OLP

Identifier Type: -

Identifier Source: org_study_id

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