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

January 3, 2019 updated by: Esraa Nashat, Cairo University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: topical chamomile
herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.
Drug: topical chamomile
herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect
Active Comparator: Topical Triamcinolone Acetonide
topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.
Drug: topical chamomile
herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain using Numerical rating scale
Time Frame: 1 month
Pain measure using Numerical rating scale
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical sign score
Time Frame: 1 month
Reduction in clinical sign score using Thongprasom et al
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chamomile in OLP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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