Antifungal Potential of Moringa Olifera Against Otomycosis

Overview

patients with Otomycosis were recognized by an ENT specialist. 20 patients were distributed randomly into two groups. The first group will be treated with Nystatin ear drops twice daily. The second group will be treated with Moringa ear drops. patients will be examined endoscopically by the ENT specialist. patient's swabs will be isolated and analyzed by ELISA.

Full Title of Study: “Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 15, 2021

Detailed Description

Inclusion criteria: (1) Otomycosis . Exclusion criteria: 1. tympanic membrane perforation; 2. concurrent immune suppression, 3. and concurrent bacterial infection.

Interventions

  • Drug: Moringa oleifera leaf 10mg/100ml
    • ear drops
  • Drug: Ear Drop
    • plain ear drop formulation without moringa

Arms, Groups and Cohorts

  • Active Comparator: Placebo group
    • Nystatin ear drops formulations prepared as intervention except for the addition of Moringa prepared using biodegradable polymers in aseptic condition and tested for sensitivity
  • Experimental: Moringa group
    • Moringa ear drops prepared using biodegradable polymers in aseptic condition and tested for sensitivity

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants recovered with clear endoscopic examination
    • Time Frame: one week
    • Number of participants recovered with clear endoscopic examination
  • Identification of different microorganisms infected ear
    • Time Frame: up to 1 month
    • Patients swabs (microorganisms concentration)

Participating in This Clinical Trial

Inclusion Criteria

1. Otomycosis 2. ear inflammation Exclusion Criteria:

1. tympanic membrane perforation 2. concurrent immune suppression, 3. concurrent bacterial infection.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Deraya University
  • Collaborator
    • Minia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soad Ali, principle investigator – Deraya University
  • Overall Official(s)
    • Soad A Mohamad, Principal Investigator, Deraya University

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