Determination of antifungal supplement properties of Zataria multiflora-loaded nanostructural lipid carriers on cutaneous candidiasis.
Determining the effectiveness of nano-thyme (in terms of mycological criteria) on the treatment of cutaneous candidiasis
Identification of yeasts isolated from patients at the cheek level by PCR-RFLP technique
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 40 patients. Www.randomizer.org was used to observe random allocation.
Settings and conduct
Forty patients referred by a physician in Sari whose cutaneous candidiasis 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 cutaneous candidiasis. 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
In this study, 40 patients with different types of cutaneous candidiasis will be studied. Cutaneous candidiasis 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 40 patients confirmed, 20 will be a test sample and 20 will be a control sample.
Main outcome variables
Treatment of cutaneous candidiasis lesions in terms of mycological criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210611051539N1
Registration date:2021-06-19, 1400/03/29
Registration timing:prospective
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
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
2021-07-06, 1400/04/15
Expected recruitment end date
2022-07-06, 1401/04/15
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 on cutaneous candidiasis
Public title
Effect of nano-Zataria multiflora supplement on cutaneous candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients presenting with mild-moderate cutaneous candidiasis 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
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to observe random allocation, the site www.randomizer.org is used and using codes based on blocking people into 2 groups, even and odd codes are installed on the drug and placebo. Then, for each group of drugs and placebo, it is placed in a special envelope and the patient number and drug code are written on the envelope.
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
Improvement of fungal lesions in terms of mycological criteria
Timepoint
Before the intervention, 2 and 4 weeks after the intervention
Method of measurement
Evaluation of clinical symptoms such as erythema, inflammation and pruritus and evaluation of negative direct examination and mycology culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients with cutaneous candidiasis (except onychomycosis), 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 patients with cutaneous candidiasis (except onychomycosis), placebo is used as a gel which is made in Mazandaran University of Medical Sciences in 60 g tubes, is applied twice a day for a month. Placebo is used as an adjunct to the main antifungal drug prescribed by dermatologist.