Comparison of the effect of garlic extract with cryotherapy in the treatment of female genital warts
Design
This study is a phase 3 clinical trial to compare garlic extract and cryotherapy in the treatment of female genital warts. The total sample size will be 100 people who will be randomly assigned in two groups of 50 people in parallel with the Rand function of Excel software.
Settings and conduct
In this clinical trial, women with genital warts referred to Fatemieh Hospital in Hamadan who have no history of previous treatment and no underlying diseases, if they agree to participate in the study, will be randomly assigned to two groups of garlic extract and cryotherapy. Both groups will be evaluated every 15 days for degree of improvement and possible side effects. Due to the nature of the study, blinding will not be performed.
Participants/Inclusion and exclusion criteria
Participants will be women with vaginal genital warts who had not been treated for the past 6 months. patients with underlying diabetes, high blood pressure, ischemic heart disease, a history of heart attack or stroke, chronic kidney disease, defective immune systems and patients under immunosuppressive drugs treatment will be excluded.
Intervention groups
Group G uses garlic extract with swab once every 12 hours to treat lesions and will be visited once every two weeks by a gynecologist for improvement and possible complications and the results will be recorded in a checklist.
Group C will undergo cryotherapy using liquid nitrogen under sterile conditions. Treatment is performed once a week under the supervision of a specialist and once every two weeks, patients are evaluated for improvement and the occurrence of possible complications.
Main outcome variables
Rate of Lesions recovery, recovery time and side effects are the three main outcome of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N20
Registration date:2022-02-28, 1400/12/09
Registration timing:prospective
Last update:2022-02-28, 1400/12/09
Update count:0
Registration date
2022-02-28, 1400/12/09
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical study of efficacy of garlic extract versus cryotherapy in the treatment of genital wart
Public title
Treatment of genital warts with cryotherapy and garlic extract
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Genital warts (vulva, vagina and pubis)
No history of treatment in the last 6 months
Exclusion criteria:
Having underlying diseases (atopy, diabetes, hypertension, ischemic heart disease, history of heart attack or stroke, chronic kidney disease)
Taking immunosuppressive drugs
Congenital or acquired immunodeficiency
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
100 samples will be randomly coded with computer software in two groups G and C and the codes will be recorded on raw checklists. By referring the patient with inclusion criteria,One of the checklists will be randomly selected. If the selected code is G, the patient will be in the garlic extract treatment group and if it is C, in the cryotherapy group.
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 Hamadan Univercity of Medical Science
Street address
shahid fahmideh avenue
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.UMSHA.REC.1400.716
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
Lesion recovery rate
Timepoint
Before treatment and every 15 days after treatment for 8 weeks
Method of measurement
Clinical examination and observation, Scoring based on Ordinal scale: poor moderate good
Secondary outcomes
1
Description
Duration of treatment
Timepoint
Once every 15 days for 8 weeks
Method of measurement
Clinical examination
2
Description
Side effects of treatment
Timepoint
Once every 15 days for 8 weeks
Method of measurement
Clinical examination and questioning of the patient
Intervention groups
1
Description
Intervention group: Will be treated with garlic extract. In order to provide garlic extract, first, pour 20 cloves of garlic in a mixer until completely chopped, then add methanol and chloroform in a ratio of 1: 2. Add the same weight of distilled water and crush it again with a mixer. After keeping the solution at room temperature for 24 hours and in a closed container, Eventually will be filtered with paper filtering and use the extract to treat patients. . Patients will be instructed to use garlic extract once every 12 hours to treat lesions using a cotton swab.
Category
Treatment - Drugs
2
Description
Intervention group: Under cryotherapy. Cryotherapy will be performed using liquid nitrogen and under sterile conditions once a week to treat genital lesions under the supervision of a gynecologist.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Mehrangiz Zamani
Street address
Pasdaran Ave
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 1827 7459
Fax
+98 81 1828 3939
Email
fatemieh@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Shokohi
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Samar Moghadami
Position
Medical Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hamedan shahid fahmideh street medicine school
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 1827 7459
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamثdan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
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
No more information
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
Undecided - It is not yet known if there will be 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