NCT04768829

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

February 18, 2021

Last Update Submit

March 8, 2022

Conditions

Otomycosis

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Placebo group

ACTIVE COMPARATOR

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

Moringa group

EXPERIMENTAL

Moringa ear drops prepared using biodegradable polymers in aseptic condition and tested for sensitivity

Drug: Moringa oleifera leaf 10mg/100ml

Interventions

Moringa oleifera leaf 10mg/100mlDRUG

ear drops

Also known as: ear drops
Moringa group
Ear DropDRUG

plain ear drop formulation without moringa

Placebo group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Otomycosis
  • ear inflammation

You may not qualify if:

  • tympanic membrane perforation
  • concurrent immune suppression,
  • concurrent bacterial infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad A. Mohamad

Minya, Minya Governorate, 05673, Egypt

Location

MeSH Terms

Conditions

Otomycosis

Interventions

Urea

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic Chemicals

Study Officials

  • Soad A Mohamad

    Deraya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: moringa extract ear drops
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 24, 2021

Study Start

February 18, 2021

Primary Completion

September 15, 2021

Study Completion

December 1, 2021

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

publication in peer-reviewed journals

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
year

Locations

EG(1)