In this clinical trial, an alcohol free skin's friend herbal solution of A-S14-1 will evaluate as a disinfectant without any above mentioned chemical compounds. The aim of the study is to evaluate the disinfecting effects of herbal solution of A-S14-1 on hand skin of 20 men and women volunteers as a before and after study on the basis of EN12791 method. Inclusion criteria included short and clean nails, lack of use of ointments, medications or antimicrobial soap for at least a week before the intervention. Exclusion criteria will pregnant women, any cuts, wounds, abrasions on hands skin and skin diseases. Effect of herbal solution of A-S14-1 on microbial count of fingers tips will compare before and after washing with the solution as EN12791 procedure. Bacterial count before and after will compare as the main outcome of variables.
General information
Acronym
Spray A-S14-1
IRCT registration information
IRCT registration number:IRCT2016020726409N1
Registration date:2016-03-27, 1395/01/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-27, 1395/01/08
Registrant information
Name
Parviz Owlia
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5522 8800
Email address
owlia@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pishgaman Armaghan Aftab Company
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of antiseptics effect of herbal solution of A-S14-1 on hand skin
Public title
Evaluation of Herbal Spray as hands Antiseptic
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Fingernails should be short and clean; Non-use of ointments, medications or antimicrobial soap for at least a week before the interventions
Exclusion criteria:
Pregnant women; There are cuts, wounds, abrasions on the skin of the hands; The risk of skin disease
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
-
Secondary Ids
1
Registry name
ND
Secondary trial Id
ND
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University, Depaty of Research
Street address
Behesht-Zahra, Khalije-Fars Freeway, Tehran
City
Tehran
Postal code
3319118651
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
IR.Shahed.REC.1394.68
Health conditions studied
1
Description of health condition studied
Topical Agent
ICD-10 code
Y56.9
ICD-10 code description
Topical agent, unspecified
Primary outcomes
1
Description
Basic Microbial count
Timepoint
Before Antisepsis by studied herbal solution
Method of measurement
Volunteers wash their hands with liquid normal soap for a minute and then rinse and drying laundry, The fingertips of both hands will rub for 1 minute in a petri dish containing 10 ml of TSB. Then,1 and 0.1 ml of the liquid will take and will culture on petri dishes containing TSA (with a glass rod head tilt). In addition, from the fluid, one-tenth dilution in TSB was prepared and 0.1 ml will culture on TSA. If necessary, microbial count will continue to further dilutions in a pour-plate method. All samples will incubate at a temperature of 37±1 for 48-24 hours and then cfu / ml.
2
Description
Microbial count immediately after antisepsis by studied herbal solution
Timepoint
immediately after antisepsis by studied herbal solution
Method of measurement
Antisepsis of both hands will carry out by 3 ml of A-S14-1 solution and rubbing. If necessary, an additional 3 ml will add. As described for basic Microbial count, the method will accomplish on randomly selected hand after 3 minutes antisepsis by studied solution. The other hand will cover with a sterile surgical glove.
Secondary outcomes
1
Description
Microbial count 3 hours after antisepsis by studied herbal solution
Timepoint
3 hours after antisepsis by studied herbal solution
Method of measurement
After 3 hours the glove from hand will remove and microbial count will perform as earlier mentioned method
Intervention groups
1
Description
Effect of herbal solution A-S14-1 product of Pishgaman Armaghan Aftab Company on microbial count of fingers tips will compare before and after washing with the solution as EN12791 procedure. The herbal solution of A-S14-1 is compatible with skin, without any alcohol and chemicals such as chlorinated compounds, silver nanoparticles, tetravalent ammonium compounds, Triclosan etc.
Antisepsis of both hands will carry out by 3 ml of A-S14-1 solution and rubbing. If necessary, an additional 3 ml will add. As described for basic Microbial count, the method will accomplish on randomly selected hand after 3 minutes antisepsis by studied solution. The other hand will cover with a sterile surgical glove.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Molecular Microbiology Research Center, Shahed University
Full name of responsible person
Professor Parviz Owlia
Street address
Research Centers of Shahed University, No.1471, First Floor, North Kargar St., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pishgaman Armaghan Aftab Company
Full name of responsible person
Ghasem Habibi Dehfooli
Street address
No. 14, Molaem, Besharat St, Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pishgaman Armaghan Aftab Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Pishgaman Armaghan Aftab Company
Full name of responsible person
Ghasem Habibi Dehfooli
Position
Chairman of the Board
Other areas of specialty/work
Street address
No. 14, Molaem, Besharat St, Arak, Iran
City
Arak
Postal code
381875875
Phone
+98 86333664708
Fax
Email
ghasemhabibi.chem@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Professor Parviz Owlia
Position
Professor in Microbiology
Other areas of specialty/work
Street address
Molecular Microbiology Research Center, Shahed University, Tehrsn, Iran
City
Tehran
Postal code
Phone
+98 21 5522 8800
Fax
Email
Owlia@Shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pishgaman Armaghan Aftab Co.
Full name of responsible person
Ghasem Habibi Dehfooli
Position
Chairman of the Board
Other areas of specialty/work
Street address
No. 14, Molaem, Besharat St, Arak, Iran
City
Arak
Postal code
3818758754
Phone
Fax
Email
ghasemhabibi.chem@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)