Determination of antifungal supplement properties of Zataria multiflora-loaded nanostructural lipid carriers on dermatophytosis .
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. Www.randomizer.org was used to observe random allocation.
Settings and conduct
80 patients referred by a physician in Sari whose dermatophytosis has been confirmed by mycological criteria (direct testing and culture) are involved. Patients in each group should be the same in terms of disease severity, lesion location, age range and sex. Patients are evaluated after 2 and 4 weeks after the start of treatment in terms of recovery and the size of the lesions, itching and inflammation, according to the opinion of a specialist. the complete recovery is based on the negative criteria of mycology (direct and culture).
Participants/Inclusion and exclusion criteria
Inclusion criteria include all patients presenting with mild-moderate dermatophytosis . It refers to patients who do not need treatment with systemic antifungals. Exclusion criteria are the use of antifungal drugs as well as children and infants in the age range of 0-10 years.
Intervention groups
number of patient 80, dermatophytosis in suspected patients is diagnosed and approved by a specialist doctor and finally diagnosed in the laboratory with the mentioned methods and according to the inclusion criteria. Of the 80 patients confirmed, 40 will be a test sample and 40 will be a control sample .Patients are divided into four groups of 20 based on gender
1. Two intervention groups, male and female with dermatophytosis, receiving thyme nano drug
2. Two comparison groups of males and females with dermatophytosis receiving placebo
Main outcome variables
Clinical criteria of dermatophytosis lesions (Itching, inflammation and scaling; mycological criteria; side effects; patients satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210611051539N2
Registration date:2021-12-25, 1400/10/04
Registration timing:registered_while_recruiting
Last update:2021-12-25, 1400/10/04
Update count:0
Registration date
2021-12-25, 1400/10/04
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
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of antifungal supplement properties of zataria multiflura - loaded nanostructural lipid carriers on dermatophytosis
Public title
effect of nano-zataria multiflora supplement on dermatophytosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients presenting with mild- moderate dermatophytosis and do not require treatment with systemic antifungals
Exclusion criteria:
taking antifungal drugs
children and infants in the age range of 0-10 years
Age
From 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to observe random allocation, patients will divided into group A and B and simple randomization is performed individually using Random number table . Allocation concealmen is done using non transparent sealed envelopes. Specializing of even and odd codes perform on the envelop for drug and placebo and only the main researcher aware of them.
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
5th Floor, shayan3 Bldg, Ghaem12 st, ghaem st ,taleghani Blvd,sari
City
ساری
Province
Mazandaran
Postal code
4817845423
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
IR.MAZUMS.REC.1400.230
Health conditions studied
1
Description of health condition studied
Dermatophytosis
ICD-10 code
B35.9
ICD-10 code description
Dermatophytosis, unspecified
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
evaluation of clinical symptoms such as inflammation , pruritus ,scaling and evaluation of negative direct and culture exam in 2 and4 weeks
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for patients with dermatophytosis(exept tinea angum and tinea capitis)1%thyme nano-gel which is made by mazandaran university of medical sciences in 60 g tubes , is applied twice a day for a month . this intervention is used as an adjunct to the main antifungal drug prescribed by dermatologist
Category
Treatment - Drugs
2
Description
Control group: for patient with dermatophytosis(except tinea angum and tinea capitis), placebo is used as a gel which is made in mazandaran university of medical science in 60g tube , is applied twice a day for a month. placebo is used as an adjunct to the main antifungal drug prescribed by dermatologist
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
toba clinic
Full name of responsible person
yaser nasirzadeh fard
Street address
clinic toba , khaxar ave, 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. majid saeedi
Street address
school of pharmacy ,payambar aazam university ,farahabad
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 bldg, ghaem12st, ghaem st, talegani blvd , sari