Protocol summary

Study aim
1.Comparison of the effect of Garlic extract on podophylline solution in treatment of female genital warts 2.Comparison of female genital warts before and at weekly intervals up to one month after the start of treatment in the intervention group with garlic extract 3.Comparison of the size of female genital warts before and at weekly intervals up to one month after the start of treatment in the intervention group with pudophilin solution 4. Comparison of female genital warts before and at weekly intervals up to one month after starting treatment in two groups of garlic extract and pudophilin solution
Design
Randomized blind, community-based, and pragmatic randomized clinical trials with parallel groups, 74 women, randomized, four-block randomized block
Settings and conduct
A daily referral to a women's office in the city of Karaj, 74 women selected by randomized block method (AABB), will be divided into two groups. During the research, the samples do not know how to divide the groups into intervention groups and the type of intervention of each group. Before the start of treatment, the size of the warts of patients will be measured using a ruler and recorded as a map. Receive treatment for 4 sessions at intervals each week for one month. The response rate will be determined based on the size of the warts.
Participants/Inclusion and exclusion criteria
Criteria for entering the study aged 18-60 years, skin disorders such as dermatitis or skin allergies, lack of systemic patients, such as diabetes, hypertension, heart disease, etc., failure to receive treatment within the past 8 weeks, lack of pregnancy or lactation , Lack of susceptibility to garlic
Intervention groups
First intervention group: Garlic extraction weekly until 4 weeks Second intervention group: pudophilin solution weekly until 4 weeks
Main outcome variables
Genital warts size

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160821029446N2
Registration date: 2018-05-02, 1397/02/12
Registration timing: prospective

Last update: 2018-05-02, 1397/02/12
Update count: 0
Registration date
2018-05-02, 1397/02/12
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of the effect of Garlic extraction with Podophyllin in the Treatment of Female Genital Warts
Public title
Comparison of the effect of Garlic extraction with Podophyllin in the Treatment of Female Genital Warts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18-60 years Lack of skin disorders such as dermatitis or skin sensitization Lack of systemic patients, such as diabetes, hypertension, heart disease, etc Lack of pregnancy or lactation No treatment within the past 8 weeks Lack of sensitivity to Garlic
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Sample allocation in two groups of Garlic extraction and Podophyllin will be performed by using the four-point blocking method (AABB). Six possible states will be considered for the AABB letters. These 6 modes are written on 6 separate cards and the cards will be placed in a black bag. For 19 times, a card will be picked up until 76 letters written in order.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as a single blind randomized clinical trial. So the participants will not be aware of the type of treatment they receive. the medicine will be used by the researcher for the patient. In addition, the appearance of garlic extraction will be similar to podophylline and will not have the smell of garlic.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Tehran University of Medical Sciences and Health Services
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.TUMS.FNM.REC.1397.4961

Health conditions studied

1

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

Primary outcomes

1

Description
Genital wart size
Timepoint
Weekly until one month
Method of measurement
ruler

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: garlic extraction that will be used by researcher on warts after covering warts perimeter with Localized softener such as Vaseline, weekly. In each session the warts' size will be measured and recorded
Category
Treatment - Drugs

2

Description
Control group: podophylline solution that will be used by researcher on warts after covering warts perimeter with Localized softener such as Vaseline, weekly. In each session the warts' size will be measured and recorded
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's office
Full name of responsible person
Dr. Seyedeh Fariba Behnam
Street address
Iran, Alborz, Karaj, Shahid Beheshti, Taleghani Crossroad, Niloufar Building
City
Karaj
Province
Alborz
Postal code
1419733171
Phone
+98 26 3223 2099
Email
zahrayesarfallah@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
Number 23, Dameshgh Street, Valiasr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Sarfallah
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Iran, Tehran, Tohid Square, Tehran University of Medical Sciences, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
zahrayesarfallah@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Iran, Tehran, Tohid Square, Tehran University of Medical Sciences, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6692 7171
Email
Maryam_damghanian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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