Determining the antiperspirant effect of the Myrtus Communis L.
Design
A clinical trial with a control group, with cross-over groups, double-blind, randomized, phase 3 on 20 volunteers, random block allocation method was used for randomization.
Settings and conduct
This project was carried out in the Faculty of Pharmacy in Yazd. Volunteers are randomly assigned to two groups, A and B, and use the product for one week, and after a two-week washout period, they are assigned to the opposite group.
Participants/Inclusion and exclusion criteria
Volunteers between the ages of 18 and 65 who do not use any other antiperspirant drugs or products. After obtaining informed consent, they entered the study. Exclusion criteria are: if serious side effects occur, menopause, pregnancy, overweight and obesity, thyroid disorders.
Intervention groups
Volunteers use a 2% spray of the Myrtus communis L extract (made in Yazd Pharmacy Faculty) for 7 days and 2 times a day in the axillary area. Control group: Volunteers use placebo spray (made in Yazd Pharmacy Faculty) for 7 days and 2 times a day in the axillary area.
Main outcome variables
Sweat intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N17
Registration date:2023-10-29, 1402/08/07
Registration timing:retrospective
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Antiperspirant effect of leaf extract of Myrtus communis L. in healthy volunteers: a double-blind randomized clinical trial
Public title
Antiperspirant effect of leaf extract of Myrtuscommunis L.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Volunteers who do not take any other antiperspirant medications or products.
Volunteers between the ages of 18 and 65
Exclusion criteria:
If serious side effects occur
Menopause
Pregnancy
Overweight and obesity
Thyroid disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 20 participants are randomly and periodically placed in one of two groups (A and B). In order to randomize, the block random allocation method was used. In this study, 4 blocks of 5 were considered. The permutations produced include the letters A and B are repeated. These permutations were produced with the help of Random allocation software version 1. For this purpose, the list prepared by the software is from number 1 to 20, which are placed in 4 blocks of five. The implementation of this software output will give the first qualified person number 1 and the last person will receive number 20.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, the physician, and the assessor of clinical symptoms will be all blinded to the intervention’s assignments during performing the study. In this way, the first executor of the sequence plan determines the allocation of individuals according to the order in which patients enter the study and puts The formulation contains the Myrtus communis L extract and placebo (the same in terms of color, smell, and shape) in the same shape boxes for patient consumption. And identifies them with codes A or B. The student then delivers the appropriate medications to the patients.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.079
Health conditions studied
1
Description of health condition studied
Sweating
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of perspiration
Timepoint
week 0 and 1
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Volunteers use a 2% spray of the Myrtus communis L extract (made in Yazd Pharmacy Faculty) for 7 days and 2 times a day in the axillary area.
Category
Treatment - Drugs
2
Description
Control group: Volunteers use placebo spray (made in Yazd Pharmacy Faculty) for 7 days and 2 times a day in the axillary area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Faculty of Pharmac
Full name of responsible person
Behrooz Heydari
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghouei
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.