Antifungal Potential of Moringa Olifera Against Otomycosis

Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Otomycosis
• Intervention / Treatment: Drug: Ear Drop; Drug: Moringa oleifera leaf 10mg/100ml

Detailed Description

Inclusion criteria:

(1) Otomycosis .

Exclusion criteria:

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • المنيا
    • Minya, المنيا, Egypt, 05673
      • Soad A. Mohamad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Otomycosis
2. ear inflammation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Ear Drop; plain ear drop formulation without moringa
Experimental: Moringa group; Moringa ear drops prepared using biodegradable polymers in aseptic condition and tested for sensitivity	Drug: Moringa oleifera leaf 10mg/100ml; ear drops; Other Names: ear drops

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Deraya University
• Collaborators: Minia University
• Investigators: Principal Investigator: Soad A Mohamad, Deraya university

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections and Mycoses; Ear Diseases; Mycoses; Otomycosis; Anti-Infective Agents, Local; Anti-Infective Agents; Carbamide Peroxide
• Other Study ID Numbers: S85Motic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: publication in peer-reviewed journals
• IPD Sharing Time Frame: year
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• 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