Sixty volunteers having the criteria of inclusion in each arm of intervention were recruited for this study. Inclusion criteria included male or female students who were 18-28 years old and diagnosed to suffer from cold sore by a dermatologist, a member of the research group. All the subjects suffered from their cold sores within 24 hr before diagnosis. The subjects were asked to apply the solution each 2 hour on the cold sore until the tingling and the sores have cleared. Thirty drug containers were containing shallomin (active fraction of shallot) and others containing ethanol. All containers just labeled for researchers and were similar looking for dermatologist. The target of this study was evaluation of treatment effect of shallomin on cold sore.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112128388N1
Registration date:2013-02-17, 1391/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-17, 1391/11/29
Registrant information
Name
Mansour Amin
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8204
Email address
amin-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz jundishaput University of Medical Scinces
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Shallomin( active fraction of shallot ) to be effective to treat cold sore of face in students of Ahvaz university of medical sciences
Public title
Evaluation of Shallomin( the active fraction of shallot) in treatment of cold sores
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age from 18 to 28; cold sore.
Exclusion criteria: Age less than 18 and more than 28;other sore;cold sore more than 24 hours old
Age
From 18 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ETH-294
Health conditions studied
1
Description of health condition studied
cold sore
ICD-10 code
B00.1
ICD-10 code description
Herpesviral vesicular dermatitis
Primary outcomes
1
Description
Adjustment treatment of sore
Timepoint
12, 24, 48. 72 hours
Method of measurement
By clinical Examination
Secondary outcomes
empty
Intervention groups
1
Description
1. Intervention groups:
Concentration of medicine: 0.5 %.
Treatment time: 48 hours.
Dose of medicine: to apply the solution each 2 hour on the cold sore.
The condition of cold sore: the sore is as new as 24 hr.
Category
Treatment - Drugs
2
Description
control groups: use of Ethanol as plasebo.
Treatment time: 48 hours.
Dose : to apply the solution each 2 hours on the cold sore.
The condition of cold sore: the sore is as new as 24 hr.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin clinic of Dr. Seyed Mohamad Radmanesh
Full name of responsible person
Dr. Seyed Mohamad Radmanesh
Street address
Skin clinic of Dr. Seyed Mohamad Radmanesh, East 4 Street, Kianpars, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghee
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mansour Amin
Position
Ph.D. of microbiology
Other areas of specialty/work
Street address
School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard , Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8204
Fax
Email
amin-m@ajums.ac.irmnsamin@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
MansourAmin
Position
Ph.D. of microbiology
Other areas of specialty/work
Street address
School of medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard
City
Ahvaz
Postal code
Phone
+98 916 305 1096
Fax
Email
amin-m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz jundishapur University of Medical scinces
Full name of responsible person
Mansour Amin
Position
Ph.D. in microbiology
Other areas of specialty/work
Street address
School of Medicine, Ahvaz jundishapur University of Medical scinces, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8204
Fax
Email
amin-m@ajums.ac.irmnsamin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)