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Comparative effect treatment of Ficus Carica Latex cream vs. Podophyllin in treatment of Genital Warts

Protocol summary

Summary
Purpose: To determine and compare the therapeutic effect of Ficus Carica cream, and Podophyllin in the treatment of genital warts. Study a double- blind randomized clinical trial .Target Population is patients with genital warts. Inclusion Criteria: Patients with genital warts disease who have been approved by the gynecologist and oncologist, Total area of warts is not greater than 10 cm ², wart area is external genital warts and anal, Gender women, patients none of the treatments had to be received in 3 ago, Less than a year having passed from patient to patient. There is no active genital herpes lesions. No skin erythema and inflammation Exclusion Criteria: Occurrence of any serious skin condition that usually does not respond to allergy medications, HIV infection The sample size in each treatment group, 46 patients, and the overall sample size is 92. Random allocation of treatment to patients using Random Allocation Software. First step is to prepare the cream of Ficus Carica latex. Drugs used in group 2, Podophyllin 20% cream. Fig creams Group, cream 3- 4 times daily by patients to the appropriate size is placed on the stand. In the group Podophyllins 20% , cream placed by programs experts and by swab on warts will be once a week. Duration of treatment every 2 group at least 2 weeks and a maximum 8 weeks. Out comes of the study determine the effectiveness, efficacy, side effect and recurrence rates warts after 3 months of treatment compare with Podophyllin. Further determine the attributable risk (AR) and the odds ratio and number needed to treat (NNT) will be calculated in the study Population

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013111015364N1
Registration date: 2014-06-25, 1393/04/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-25, 1393/04/04
Registrant information
Name
Sepideh Mahdavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3228 0917
Email address
sepideh.mahdavi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoghi Yazd University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect treatment of Ficus Carica Latex cream vs. Podophyllin in treatment of Genital Warts
Public title
Comparative effect treatment of Ficus Carica Latex cream vs. Podophyllin in treatment of Genital Warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with genital warts disease who have been approved by the gynecologist and oncologist. Total area of ​​warts is not greater than 10 cm ², wart area is external genital warts and anal, Gender women, patients none of the treatments had to be received in 3 month ago, Less than a year having passed from patient to patient. There is no active genital herpes lesions. No skin erythema and inflammation Exclusion Criteria: Occurrence of any serious skin condition that usually does not respond to allergy medications, HIV infection
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shahid Sadoghi University of Medical Science
Street address
Health College, Shahid Sadoghi University of Medical Science, Daneshjo Bolvar, Emam Hosein Square, Yazd
City
Yazd
Postal code
91165-887
Approval date
2013-07-29, 1392/05/07
Ethics committee reference number
17/1/81438/پ

Health conditions studied

1

Description of health condition studied
Genital Wart
ICD-10 code
A63.0
ICD-10 code description
Anogenital (venereal) warts

Primary outcomes

1

Description
Comparative effect treatment of Ficus Carica Latex cream and Podophyllin in treatment of Genital Warts
Timepoint
Before intervention, One month after the intervention, 8 week after the intervention, one months after the end of intervention
Method of measurement
Number and total area of warts and warts in the beginning and during the treatment, Visit and use Photography

Secondary outcomes

1

Description
Determine and Compare side effect of Ficus Carica Latex cream vs. Podophyllin in treatment of Genital Warts
Timepoint
One month after the intervention- After the intervention
Method of measurement
A visual examination by a gynecologist- A patient questionnaire complications include itching, burning, pain, and inflammation

2

Description
Determine and compare the recurrence rate of genital warts after one months after completion of treatment in both treatment groups
Timepoint
One months after the intervention.
Method of measurement
Photo taken from the baseline and end of treatment. Counting the number of warts- Warts area Comparison

3

Description
Determine and compare patient satisfaction with treatment compared with Ficus Carica cream vs Podophyllin
Timepoint
After treatment
Method of measurement
Questionnaire including questions of overall satisfaction, satisfaction with treatment site, and overall satisfaction with the group treated with 5 benchmark score

Intervention groups

1

Description
The intervention in case group is by Ficus Carica latex cream. This cream pharmaceutical processes using latex of Figs and pharmaceutical base creams and Vaseline with varying proportions of each material is produced. Cream is made of 20% Fig latex. Term use of this cream will be at least 2 weeks and a maximum of 8 weeks. Cream 3- 4 times daily by the patients themselves and by the swab is placed on warts
Category
Treatment - Drugs

2

Description
Control group using standard methods of genital warts treatment is called Podophyllin. Podophyllin 20% in this study is used in the cream forms. Treatment in this group will be at least two weeks and a maximum of 8 weeks. Cream once a week by an programs expert is placed on the warts and be patient to wait for a few minutes on the bed and get up out of bed and put on clothes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghai por clinic,Shahid Sadoghi hospital in Yazd
Full name of responsible person
Doctor Mozhgan Karimi
Street address
Ebne Sina street ,Sh.Ghandi bolvar, Safaie, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoghi Yazd University of Medical Sciences
Full name of responsible person
Dr. Fateme Ezeddini
Street address
Vice chancellor for research, Headquarters of Shahid Sadoghi University of Medical Science, Bahonar Square, yazd
City
Yazd
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, Shahid Sadoghi Yazd 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
Health College, Shahid Sadoghi University of Medical Science
Full name of responsible person
Sepideh Mahdavi
Position
Post graduate student/ Epidemiology
Other areas of specialty/work
Street address
4 Floor, 114 Number, Elahi street( 216East street), Fourth Sguare Tehran Pars, Tehran
City
Tehran
Postal code
Phone
+98 21 7706 1380
Fax
Email
sepideh.mahdavi@ssu.ac.ir; s.mahdavi88@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health College, Shahid Sadoghi University of Medical Science
Full name of responsible person
Sepideh Mahdavi
Position
Post graduate student/ Epidemiology
Other areas of specialty/work
Street address
4 Floor, 114 Number, Elahi street( 216East street), Fourth Sguare Tehran Pars, Tehran
City
Tehran
Postal code
Phone
+98 21 7706 1380
Fax
Email
sepideh.mahdavi@ssu.ac.ir; s.mahdavi88@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Health College, Shahid Sadoghi University of Medical Science
Full name of responsible person
Sepideh Mahdavi
Position
Post graduate student/ Epidemiology
Other areas of specialty/work
Street address
4 Floor, 114 Number, Elahi street( 216East street), Fourth Sguare Tehran Pars, Tehran
City
Tehran
Postal code
Phone
+98 21 7706 1380
Fax
Email
sepideh.mahdavi@ssu.ac.ir
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
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