Protocol summary

Study aim
Determining the antifungal effect of supplementing lipid nanostructures loaded with Shirazi thyme on patients with onychomycosis caused by filamentous fungi.
Design
In this study, which is a double-blind clinical trial, 30 patients with the desired disease will be included in the plan, and out of 30 confirmed patients, 15 will be in the experimental group and 15 will be in the control group. All the patients After being referred by a doctor to a specialized mycology laboratory, the patient will be examined and if the microscopic observation and culture are positive, they will be included in the plan.
Settings and conduct
The location of the project will be in the specialized mycology laboratory of Mazandaran Medical Sciences, in Toubi Clinic, Mazandaran. After entering the sampling, the samples will be checked for fungal agents, and after recording the results, the patient will receive medicine or a placebo and will be evaluated at intervals of 2, 4, and 6 weeks.
Participants/Inclusion and exclusion criteria
Entry requirements: All patients with mild-moderate onychomycosis caused by filamentous fungi over 18 years of age who have not taken antifungal drugs a month before treatment. Exit conditions: 1- Taking antifungal drugs before and during the study 2- Children and infants 1-18 years old 3- Allergy to herbal products
Intervention groups
Intervention and control group: For patients with onychomycosis caused by filamentous fungi, 1% nano thyme gel made in Mazandaran University of Medical Sciences in 60 gram tubes is used twice a day for 1 month. It is used as an auxiliary drug along with the main drug (Itraconazole) which is determined by a specialist doctor. The control group will receive a placebo in addition to the main drug, the same as the intervention group
Main outcome variables
Improvement of fungal lesions in terms of clinical and mycological criteria

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210611051539N3
Registration date: 2023-03-05, 1401/12/14
Registration timing: registered_while_recruiting

Last update: 2023-03-05, 1401/12/14
Update count: 0
Registration date
2023-03-05, 1401/12/14
Registrant information
Name
Maryam Moazeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 7911
Email address
moazeni.maryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of antifungal supplement properties of zataria multiflora - loaded nanostructural lipid carriers in the treatment of onychomycosis caused by filamentous fungi
Public title
Evaluation of the effect of Nano zataria multiflra antifungal supplement on patients with onychomycosis with saprophytic agent
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people over 18 years old with mild-moderate onychomycosis caused by filamentous fungi
Exclusion criteria:
Patients who have taken antifungal drugs during treatment
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In that study, nano thyme gel and placebo were prepared in completely similar packaging and drug tubes, and in order to observe random allocation, www.randomizer.org was used in such a way that by using the codes received from the site, the drug and The isolated placebo is then placed inside a similar envelope and presented to the patient in a completely random manner. Therefore, the patient will not be informed about the nature of the drug and the type of group it belongs to. Since the smell created by Shirazi thyme essential oil can cause deviations in the study, therefore, both the drug and the placebo are mixed together in a closed tube and the doctor or expert randomly gives the drug to the patient. Gives.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients participating in the study, as well as the researcher, including the master student who is responsible for their dissertation, as well as the physicians who perform the intervention, are among the people who are blinded in the study. The drug and placebo are both placed in similar envelopes. The fellow doctors and graduate students who are performing the intervention are not aware of its contents. Only the drug code and the patient code will be stated in the questionnaire. But the executor is aware of the code as an analyst and assigns it to control and intervention groups. Participants, on the other hand, are not aware of the contents of the envelope, but will be informed that their supplement may be a placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Faculty of Medicine- Payambar azam university-18th Km of Farah Abad Road- Sari
City
Sari
Province
Mazandaran
Postal code
4817845423
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.MAZUMS.REC.1401.496

Health conditions studied

1

Description of health condition studied
onychomycosis
ICD-10 code
B35.1
ICD-10 code description
Tinea unguium

Primary outcomes

1

Description
improvment of fungal lesions in term of clinical and mycological criteria
Timepoint
before the intervention and 2,4 weeks after the treatment start
Method of measurement
Examining clinical symptoms such as inflammation, itching, scaling and examination in terms of direct smear and fungal culture in the interval of 2, 4 and 6 weeks.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: For patients with onychomycosis caused by filamentous fungi, 1% nano thyme gel made in Mazandaran University of Medical Sciences in 60 gram tubes is used twice a day for 1 month. Auxiliary medicine is taken along with the main medicine that is determined by a specialist doctor.
Category
Treatment - Drugs

2

Description
Control group: For patients with onychomycosis caused by filamentous fungi, a placebo gel made in Mazandaran University of Medical Sciences in 60 gram tubes is used twice a day for 1 month. It is consumed by a specialist doctor.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Toba Clinic
Full name of responsible person
Alireza Amini
Street address
Clinic toba , Khazar Blv, Khaxar Sq
City
Sari
Province
Mazandaran
Postal code
4817845423
Phone
+98 11 3324 0003
Email
yaser.nasirzadeh0251@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Moazlem Sq.
City
Sari
Province
Mazandaran
Postal code
4817845423
Phone
+98 11 5233 1197
Email
moazeni.maryam@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Maryam Moazeni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
Shayan 3 bld, Ghaem12 st, Ghaem st, Talegani blvd , Sari
City
Sari
Province
Mazandaran
Postal code
4817845423
Phone
+98 11 5233 1197
Email
moazeni.maryam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Moazeni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
5th Floor , Shayan 3 Building, Ghaem 12 Alley, Ghaem Street, Sari Town, Mazandaran, Iran
City
sari
Province
Mazandaran
Postal code
4817845423
Phone
+98 11 3325 7911
Email
moazeni.maryam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Maryam Moazeni
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
Shayan 3 Bldg, Ghaem 12 St., Ghaem St., Taleghani Blvd., Sari
City
sari
Province
Mazandaran
Postal code
4817845423
Phone
+98 11 3325 7911
Email
moazeni.maryam@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of this study will be published in an article.
When the data will become available and for how long
Unknown
To whom data/document is available
Public
Under which criteria data/document could be used
To use the results of clinical trials and to register a patent
From where data/document is obtainable
Scientific journals and article search databases
What processes are involved for a request to access data/document
Search and view
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