<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03793634</url>
  </required_header>
  <id_info>
    <org_study_id>chamomile in OLP</org_study_id>
    <nct_id>NCT03793634</nct_id>
  </id_info>
  <brief_title>Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus</brief_title>
  <official_title>Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and&#xD;
      anticarcinogenesis effect with little side effects is the aim for the future treatment of&#xD;
      OLP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that&#xD;
      affects skin and any mucous membrane particularly oral mucosa.The patient complains of&#xD;
      burning sensation, pain; interference with eating, swallowing and speech leading to worsening&#xD;
      of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic&#xD;
      and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species&#xD;
      (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future&#xD;
      therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The supervisor(AA) will be blind. The principle investigator(EN) will supply the patient with the treatment.&#xD;
The supervisor (AA) will assess the clinical parameters before treatment , between visits and at the end of the treatment.&#xD;
Statistician will be blind. Double - blind study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain using Numerical rating scale</measure>
    <time_frame>1 month</time_frame>
    <description>Pain measure using Numerical rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical sign score</measure>
    <time_frame>1 month</time_frame>
    <description>Reduction in clinical sign score using Thongprasom et al</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Oral Lichen Planus</condition>
  <arm_group>
    <arm_group_label>topical chamomile</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical Triamcinolone Acetonide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical chamomile</intervention_name>
    <description>herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect</description>
    <arm_group_label>Topical Triamcinolone Acetonide</arm_group_label>
    <arm_group_label>topical chamomile</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic OLP.&#xD;
&#xD;
          -  Patients with no history of taking corticosteroids for the last 6 months.&#xD;
&#xD;
          -  Patients who agree to take medication.&#xD;
&#xD;
          -  Medically free&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with oral lesions other than OLP.&#xD;
&#xD;
          -  Lichenoid reaction .&#xD;
&#xD;
          -  Pregnant females and lactation.&#xD;
&#xD;
          -  Smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Esraa Nashat</investigator_full_name>
    <investigator_title>11 saraya st - manial - cairo</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lichen Planus, Oral</mesh_term>
    <mesh_term>Lichen Planus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03793634
org study id: chamomile in OLP
nct id: NCT03793634
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: 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.
measure: Pain using Numerical rating scale
time frame: 1 month
description: Pain measure using Numerical rating scale
measure: clinical sign score
time frame: 1 month
description: Reduction in clinical sign score using Thongprasom et al
arm group label: topical chamomile
arm group type: Experimental
description: herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect.
arm group label: Topical Triamcinolone Acetonide
arm group type: Active Comparator
description: topical triamcinolone acetonide is the gold standard treatment of oral lichen planus.
intervention type: Drug
intervention name: topical chamomile
description: herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect
arm group label: Topical Triamcinolone Acetonide
arm group label: topical chamomile
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Esraa Nashat
investigator title: 11 saraya st - manial - cairo
mesh term: Lichen Planus, Oral
mesh term: Lichen Planus