Protocol summary

Summary
Warts are prevalent suffering which are arising from infection of epithelial cell of skin with HPV virus. Common warts usually are seen in children. There is no special treatment for warts. We can use different methods such as cryotherapy curettage, after local anesthesia which is done by cautery or electrodesccation different treatments such as cauterizing, cryotherapy and … have their difficulties and side effects and the treatment is not positive and takes much expenses. In our research we are supposed to investigate the local consumption of HD pills in some women and show their remedial effects. In case of giving result, we can present the new ways of less expensive, without side effects to the scientific centers. METHODOLOGY: this is an RCT survey, population study in this study was population of baneh city, sample volume of 60 people with skin warts which 30 of them are in HD and 30 in placebo groups, the method of taking samples is in form of having four parts block. The facts are according to questionnaire inquiry about the effects of treatment of the HD pills in different times has been recorded and the facts are given to computer and analyzed by SPSS software.Inclusion criteria in this study was age above 10 years and exclusion criteria were pregnancy,contraindication of ocp and cancer.primary outcome was change in size of warts that controlled in 1 week after the treatment and secondary outcome was removing of warts that controlled in 1 month after the treatment. At the end regarding to effect of skin warts the treatment with the local consumption of HD pills about %70 in comparison with expensive treatment and having side effects and long term of treatment such as using : interferon cryotherapy , thermotherapy and … . It looks that the mentioned treatment is very cheap and effective and can be spread in wide range. KEY WORDS: warts, estrogen, papilloma virus, local treatment

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138712171750N1
Registration date: 2009-04-11, 1388/01/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2009-04-11, 1388/01/22
Registrant information
Name
shokrollah zandi
Name of organization / entity
kurdestan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 910 808 0245
Email address
zandi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdestan University Of Medical Science
Expected recruitment start date
2010-09-21, 1389/06/30
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assigning The Treating Effect Of Local Consumption Of Contraceptive Pills On The Treatment Of Skin Warts
Public title
Assigning The Treating Effect Of Local Consumption Of Contraceptive Pills On The Treatment Of Skin Warts
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria : Pregnancy,Contraindication of ocp,Cancer Inclusion criteria : age above 18 years
Age
From 10 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee Of Kurdestan University Of Medical Science
Street address
Pasdaran street , Kurdestan University Of Medical Science
City
Sanandaj
Postal code
Approval date
2008-06-24, 1387/04/04
Ethics committee reference number
6

Health conditions studied

1

Description of health condition studied
wart treatment
ICD-10 code
B07
ICD-10 code description
Viral warts

Primary outcomes

1

Description
Change In Size Of Warts
Timepoint
1 week
Method of measurement
observation

Secondary outcomes

1

Description
Removing Of Warts
Timepoint
1 month
Method of measurement
observation

Intervention groups

1

Description
Topical use of HD tablets
Category
Treatment - Drugs

2

Description
Topical use of placebo tablets
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hygin Center Of Baneh
Full name of responsible person
shokrollah Zandi
Street address
Jahad Square Hygin Center Of Baneh
City
Baneh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdestan University Of Medical Science
Full name of responsible person
Dr.Ataollah Haidari
Street address
Pasdaran street, Kurdestan University Of Medical Science
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdestan University Of Medical Science
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
Kurdestan University Of Medical Science
Full name of responsible person
Shokrollah Zandi, Razieh Ahmadzadeh
Position
M.D.
Other areas of specialty/work
Street address
Abidar street,Center Of Kurdestan University Of Medical Science
City
Sanandaj
Postal code
Phone
+98 910 808 0245
Fax
Email
zandi611@yahoo.com; andishe.63@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdestan University Of Medical Science
Full name of responsible person
ُShokrollah Zandi
Position
M.D.
Other areas of specialty/work
Street address
Abidar street, Center Of Kurdestan University Of Medical Science
City
Sanandaj
Postal code
Phone
+98 910 808 0245
Fax
Email
zandi611@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdestan University Of Medical Science
Full name of responsible person
shokrollah zandi
Position
M.D.
Other areas of specialty/work
Street address
City
Sanandaj
Postal code
Phone
Fax
zandi611@yahoo.com
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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