(1) Objective: To introduce the hydroalcholoic extract of the aerial parts of Allium porrum L as an inexpensive ,available treatment for common warts without complications.
(2)Experiment Design: patients with common warts on their hands were divided into two groups :first one treated with cryotherapy and the second group treated with the topical application of the hydroalcholoic extract of the aerial parts of Allium porrum L . 60 patients ,who were not randomly selected, entered in a not blinded, single center experiment with no placebo-control.
(3)Setting and conduct: The patients were not randomly selected and after taking written consent entered the study and were monitored on a weekly basis.
(4)The main criteria for inclusion: common warts on the hand. The main criteria for exclusion: a progressive systemic disease or skin disease.
(5)Interventions: The control group were treated with cryotherapy once a week for up to three weeks and the case (study ) group were treated with the topical application of the hydralcoholic extract of the aerial parts of Allium porrum L for two hours on a daily basis for three weeks.
6)The main variables: Measuring the diameter of warts and taking their pictures before the intervention, one week after the intervention, two weeks after the intervention, and three weeks after intervention ,as well as developing a questionnaire to determine patient satisfaction and the side effects of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081629392N1
Registration date:2017-03-22, 1396/01/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-22, 1396/01/02
Registrant information
Name
Mostafa Alizadeh
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1814 6851
Email address
h.hamidi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences.
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of cryotherapy and hydroalcholic extract of the aerial parts of Allium porrum in the treatment of common warts.
Public title
The effect of Allium porrum in the treatment of common warts.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with common warts on the clinic of Medical Sciences in 94-95؛ written informed consent from patients for the study.
Exclusion criteria: Pregnancy؛ breastfeeding the baby؛ a immunodeficiency disorders؛ progressive systemic diseases؛ blistering disorders, allergy history, treatment during recent 2 months.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences.
Street address
Arak University of Medical Sciences, Basij SQ, Sardasht, Arak.
City
Arak
Postal code
3848176941
Approval date
2015-04-15, 1394/01/26
Ethics committee reference number
IR.ArakMU.REC.1394.11
Health conditions studied
1
Description of health condition studied
wart
ICD-10 code
b07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
Warts's diameter
Timepoint
Baseline and every week to three weeks after intervention
Method of measurement
Ruler
Secondary outcomes
1
Description
pain
Timepoint
During treatment
Method of measurement
questionnaire
2
Description
hypopigmentation
Timepoint
End of treatment
Method of measurement
Questionnaire and examination
3
Description
hyperpigmentation
Timepoint
end of treatment
Method of measurement
Questionnaire and examination
4
Description
Blister
Timepoint
At the end of the treatment
Method of measurement
Questionnaire and examination
5
Description
Recurrence
Timepoint
end of treatment
Method of measurement
Questionnaire and examination
6
Description
Satisfaction
Timepoint
During and at the end of the treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
The control group consisted of thirty patients with common warts on their hands who were treated with cryotherapy as a standard treatment. Patients were treated with cryotherapy once a week for up to three weeks in such a way that in each session one millimeter of the skin around the warts would get whiten.
Category
Treatment - Other
2
Description
The intervention group included thirty patients with common warts on their hands who were treated by topical application of the hydralcoholic extract of the aerial parts of Allium porrum L for up to three weeks. In such a way that the patients would put a clean piece of cotton dipped in the solution and placed it on the lesion .Then after two hours it would be debrided using warm water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Reza (PBUH)
Full name of responsible person
Dr. Hamid Hamidi
Street address
Clinic of Imam Reza (PBUH), Valiasr St, Arak.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Arak University of Medical Sciences.
Full name of responsible person
Dr. Mohammad Rafiei
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Hamid Hamidi
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak.
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
hamidhamidi432@gmail.com; h.hamidi@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hamid Hamidi
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak.
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
hamidhamidi432@gmail.com; h.hamidi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mastafa Alizadeh
Position
Medical student
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht, Arak.
City
Arak
Postal code
Phone
+98 86 3417 3645
Fax
Email
mstf.alizadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)