Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Green Tea Buccal Tablets in Oral Lichen Planus
Previous Study | Return to List | Next Study

Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03415165
Recruitment Status : Unknown
Verified January 2018 by Esraa Magdy, Cairo University.
Recruitment status was:  Recruiting
First Posted : January 30, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Esraa Magdy, Cairo University

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date February 13, 2018
Actual Study Start Date  ICMJE January 3, 2018
Estimated Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
size of the lesion [ Time Frame: 12 weeks ]
the shape and the measurement of its size
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
visual analogue score [ Time Frame: 12 weeks ]
pain score from 0 to 10
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus
Official Title  ICMJE Efficacy of 200mg and 300mg Concentrates of Green Tea Polyphenols Using Buccal Tablets Versus Topical Application of Corticosteroids in Treatment of Patients With Symptomic Oral Lichen Planus Randomized Clinical Trial
Brief Summary Is topical application of green tea polyphenols buccal tablet more effective in treatment of patients with symptomatic oral lichen planus in comparison with topical application of corticosteroids and what is the most effective concentration of polyphenols
Detailed Description
  • Each patient was informed about the detailed procedure, and educated about benefits of the treatment, the known side effects and follow-up appointments needed. After that, each subject participating in the study signed an informed written consent form.
  • Subjects were given freedom to leave the study at any time when they need to. Group A (Experimental group) 200 mg green tea

Where patients in this group will receive a buccal tablet containing 200 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.

Preparation of buccal tablets : Mucoahesive buccal tablets is prepared by a direct compression procedure. Various batches are prepared by varying the chitosan:drug ratio to identify the most effective formulation. The mucoadhesive drug/polymer mixture is prepared by homogeneous mixing of the drug with chitosan , secondary polymer, and D-mannitol, in a glass mortar for 15 min. Then, Mg stearate will be added and mixed for 5 min .The mixture is compressed using a tablet machine (Type EK: O.Erweka apparatus, Frankfurt, Germany) using flat-tip punches and dies with 8-mm-diameter. Each tablet weighed 212 mg with a thickness of 3.1 mm.( Darwish and Elmeshad,2009)

Group B (Experimental group) 300 mg green tea

Where patients in this group will receive a buccal tablet containing 300 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.

Group C (Control group) corticosteroid group:

Where patients are treated with topical corticosteroids 1 mg/g Triamcinolone acetonide (Kenacort-A orabase 20 G Pomad: Deva dermatological product,Turkey) applied topically 4 times a day i.e. following each meal and at bed time for four weeks .

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Oral Lichen Planus
Intervention  ICMJE
  • Drug: green tea buccal tablet
    buccal tablet for 8 hrs 3 times aday
    Other Name: catechines
  • Drug: Corticosteroids Topical
    kenacort in orabase 4 times aday
    Other Name: local corticosteroids
Study Arms  ICMJE
  • Active Comparator: green tea buccal tablet
    buccal tablet 3 times aday
    Intervention: Drug: green tea buccal tablet
  • Sham Comparator: corticosteroids topical
    topical steroids 3 times aday
    Intervention: Drug: Corticosteroids Topical
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 29, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2019
Estimated Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Symptomatic lesions.
  • OLP lesions with the diagnosis confirmed both clinically and histopathologically.
  • Clinical score higher than 3.
  • Disease duration of more than 2 months.
  • Absence of dysplasia in histological section

Exclusion Criteria:

  • Presence of any visible oral lesion other than OLP.
  • Pregnant or breast-feeding women,
  • Immuno-deficiency diseases.
  • Current malignancy or malignancy in history.
  • Concomitant treatment potentially effective on OLP within the previous 2 months such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs.
  • Severe or recurrent infections.
  • Lichenoid reaction.
  • Patients presents with skin lesions which may require systemic corticosteroid therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03415165
Other Study ID Numbers  ICMJE 161187
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Esraa Magdy, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: cairo university cu
PRS Account Cairo University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP