Comparison of the therapeutic Effect of euphorbia helioscopia latex with Cryotherapy in treament of common and plantar warts
Design
we choose 100 patient with bilateral common and plantar warts and use cryotherapy for one side warts and use euphorbia helioscopia latex for the other side.
Settings and conduct
Place of study: Dermatology Clinic of Imam Khomeini Hospital in Ardebil
100 patients will be selected with bilateral warts. After obtaining informed consent from the patient and recording personal information, the size of the warts will be recorded with anatomical location and photos of the lesions. Then, for warts on the one side, cryotherapy and for the opposite side warts will be used topically the latex of euphorbia helioscopia. The treatment sessions will be repeated q 2 weeks and will be repeated for 3 times. Each time the size of the warts is recorded.
Participants/Inclusion and exclusion criteria
Participants include 5-40 y. old people .They have negative PMH. They have the right to participate in the study. They can be involved; Conditions of non entering and leaving the study include pregnancy, incontinence of uncontrolled side effects, dissatisfaction, failure to continue cooperation and ...
Intervention groups
the study includ,cryotherapy and topical use of the euphorbia helioscopia latex on common and plantar warts.
Main outcome variables
Determine the therapeutic Effect of euphorbia helioscopia latex on common and plantar warts;Determine the therapeutic efficacy of euphorbia helioscopia latex versus cryotherapy on common and plantar warts;Determnation of Side effect of the latex on common and plantar warts;Removing warts;Reducing in pain of therapy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180807040734N1
Registration date:2018-10-14, 1397/07/22
Registration timing:registered_while_recruiting
Last update:2018-10-14, 1397/07/22
Update count:0
Registration date
2018-10-14, 1397/07/22
Registrant information
Name
Ava Bohlouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3345 2206
Email address
ava.bohlooli@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effects of Euphorbia Helioscopia latex with cryotherapy on common and plantar warts
Public title
Comparison of the therapeutic effects of Euphorbia Helioscopia latex with cryotherapy on common and plantar warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 5-40 y.
having bilateral common or plantar warts
negative PMH
Collaboration can be provided to the patient by the end of the project
The patient has the consent to cooperate
Exclusion criteria:
pregnancy
any systemic diseases
metabolic disorders and any positive PMH
uncontrollable side effects
Failure to continue cooperation by the patient
Age
From 5 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
University of medical since,Daneshgah Ave,Ardebil town
City
Ardebil
Province
Ardabil
Postal code
56189-85991
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
Ir.arums.rec.1396.83
Health conditions studied
1
Description of health condition studied
common and plantar warts
ICD-10 code
B07
ICD-10 code description
Viral warts
Primary outcomes
1
Description
The amount of warts resized in response to treatment with euphorbia helioscopia latex and cryotherapy
Timepoint
In the first visit and after 2,4 and 6 w.and 6 months after the last session of treatment
Method of measurement
With colis the largest diameter of the warts is measured and with anatomical position is recorded.
Secondary outcomes
1
Description
Pain score during the treatment
Timepoint
At the first session of treatment
Method of measurement
A score 0 to 10 will be given by the patient separately for each treatment intervention in the first session.
Intervention groups
1
Description
Intervention group 1: one side plantar and common warts،intervention In this group is the use of Euphorbia helioscopia latex، fresh and topically proportional to the size of the warts surface (0.1 ml / mm 2), which is the first session, 2 and 4 weeks later. The maximum number of treatment sessions, like cryotherapy, will be 3 sessions; Intervention group 2: common and plantar warts in the otherside, intervention in this group will use cryotherapy with the prescribed therapeutic standards. It will be done at the first session and 2, 4 weeks later.The maximum number of treatment sessions will be 3 sessions.
Category
Treatment - Drugs
2
Description
Intervention group 2: common and plantar warts in the otherside, intervention in this group will use cryotherapy with the prescribed therapeutic standards. It will be done at the first session and 2, 4 weeks later.The maximum number of treatment sessions will be 3 sessions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeyni hospital
Full name of responsible person
Dr. Majid Rostami
Street address
No.19,West 14,Enghelab Ave,Ardebil Town
City
Ardebil
Province
Ardabil
Postal code
5614891971
Phone
+98 45 3345 2206
Email
ava.bohlooli@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Ghasem Golmohammadi
Street address
University of medical since,Daneshgah Ave,Ardebil Town
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3352 2247
Fax
+98 45 3352 2196
Email
ava.bohlooli@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
70
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
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Majid Rostami
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.19,West14,Enghelab Ave,Ardebil Town
City
Ardebil
Province
Ardabil
Postal code
5614891971
Phone
+98 45 3345 2206
Email
ava.bohlooli@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ava Bohlouli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.19,14 West,Enghelab Ave,Ardebil Town
City
Ardebil
Province
Ardabil
Postal code
5614891971
Phone
+98 45 3345 2206
Email
ava.bohlooli@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ava Bohlouli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.19,14 West,Enghelab Ave,Ardebol Town
City
Ardebil
Province
Ardabil
Postal code
5614891971
Phone
+98 45 3345 2206
Email
ava.bohlooli@arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
According to the subject, patients' information is reported in terms of gender, age, size and number of germs, response to treatment, and complications.without patients name...
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Academic and academic researchers in the pharmaceutical industry
Under which criteria data/document could be used
Upon confirmation from the university, information will be provided to the applicant for further medication or further study.
From where data/document is obtainable
With the research unit of Ardabil University of medical sciences,
Agree with Dr. Majid Rostami or me.09141599447
What processes are involved for a request to access data/document
Referring to Ardabil Medical School ... which will provide the necessary guidance