OtomycosisEarly Phase 1NCT04768829
Antifungal Potential of Moringa Olifera Against Otomycosis
A Early Phase 1 study testing Moringa oleifera leaf 10mg/100ml and Ear Drop in people with Otomycosis, run by Deraya University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Otomycosis
- What is being tested?
- Moringa oleifera leaf 10mg/100ml and Ear Drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2021to 1 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Otomycosis
- ear inflammation
Who cannot join
- tympanic membrane perforation
- concurrent immune suppression,
- concurrent bacterial infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Inclusion criteria:
(1) Otomycosis .
Exclusion criteria:
- tympanic membrane perforation;
- concurrent immune suppression,
- and concurrent bacterial infection.
- Conditions
- Otomycosis
- Being tested
- Moringa oleifera leaf 10mg/100ml, Ear Drop
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera leaf 10mg/100mlDrug
Also called ear drops
ear drops
Ear DropDrug
plain ear drop formulation without moringa
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ear Drop |
| Moringa group | Experimental | Moringa ear drops prepared using biodegradable polymers in aseptic condition and tested for sensitivity Receives: Drug: Moringa oleifera leaf 10mg/100ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recovered with clear endoscopic examination
Number of participants recovered with clear endoscopic examination
Measured: one week
Identification of different microorganisms infected ear
Patients swabs (microorganisms concentration)
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start18 Feb 2021
- Primary completion15 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- moringa extract ear drops
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Principal investigator, Soad Ali, Deraya University
- Investigators
- Soad A Mohamad, Principal investigator, Deraya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768829
- Sponsor's protocol ID
- S85Motic
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publication in peer-reviewed journals
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation
- ClinicalTrials.gov ID
- NCT04768829
- Acronym / sponsor ID
- S85Motic
- Conditions
- Otomycosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion criteria:
(1) Otomycosis .
Exclusion criteria:
- tympanic membrane perforation;
- concurrent immune suppression,
- and concurrent bacterial infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- moringa extract ear drops
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Active comparator | Drug: Ear DropNystatin ear drops formulations prepared as intervention except for the addition of Moringa prepared using biodegradable polymers in aseptic condition and tested for sensitivity |
| Moringa group | Experimental | Drug: Moringa oleifera leaf 10mg/100mlMoringa ear drops prepared using biodegradable polymers in aseptic condition and tested for sensitivity |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Otomycosis
- ear inflammation
Key exclusion criteria (3 listed)
- tympanic membrane perforation
- concurrent immune suppression,
- concurrent bacterial infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa oleifera leaf 10mg/100mlAlso: ear dropsear drops | Drug | Moringa group |
| Ear Dropplain ear drop formulation without moringa | Drug | Placebo group |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: Yes. publication in peer-reviewed journals
Related trials for Otomycosis
Recruiting
Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Otomycosis, Antifungal Agents
Not yet recruiting
Terbinafine Hydrochloride for the Treatment of Otomycosis
Otomycosis, Fungal Ear Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soad A Mohamad principal investigator
Deraya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Moringa oleifera leaf 10mg/100ml and Ear Drop in people with Otomycosis, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recovered with clear endoscopic examination (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.