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Niosomal Propolis as Oromucoadhesive Film: In-vitro, Ex-vivo & In-vivo Investigations

NCT03615820 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-08-06

No results posted yet for this study

Summary

A total of 24 patients suffering from RAU, they were divided into two groups each included 12 patients. The first group was treated by the propolis mucoadhesive film and the second group received the film without the active component (placebo group).Patients were handed a checklist for monitoring the actual improvement of the clinical parameters which included; duration of disappearance of pain after film application (hours), duration of complete healing of the aphthous ulcer (weeks), onset of ulcer size reduction after film application (days), duration of propolis film adherence onto the oral mucosa (hours) and finally the level of patient satisfaction scaled from 1-10.

Conditions

  • Drug Effect
  • Drug Effect Prolonged

Interventions

DRUG

Niosomal PPE oromucoadhesive film

Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film

DRUG

Oromucoadhesive film

Oromucoadhesive film without PPE control testing which represents Placebo group

Sponsors & Collaborators

  • British University In Egypt

    lead OTHER

Principal Investigators

  • Mona G Arafa, PhD · The British University in Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-01-30
Completion
2018-01-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615820 on ClinicalTrials.gov