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Comparing the effects of Shallomin( a pure fraction of shallot extract) and Podophyllin solution 25% in treatment of genital HPV warts in women

Protocol summary

Summary
Objectives: Estimating and comparing the effects of Shallomin and Podophyllin solution 25% in treatment of genital HPV warts in women Design:International Setting and conduct: 60 women with major inclusion and exclusion criteria that include: being older than 15 years with genital human papilloma virus warts on the vulva with lesions less than 2 cm where be enrolled in this study. After getting a written consent, patient randomly divides into two groups. At baseline, information about the patient, and physical exam findings, such as the place and the number of the lesion will be collected Intervention: in the first group, Shalomin will be used for treatment, using an applicator to apply it on the lesion. In the second group, Podophyllin solution 25% is applied with an applicator on the lesion.Before using the drug the surrounding of the lesion is coated with zinc oxide cream. Patients were advised to wash the place after 4 hours.Patients are treated on a weekly basis until full recovery from lesion for 6 weeks and at every appointment, the number of lesions and possible side effects are recorded main outcome measures (variables): The primary outcome is the improvement of genital warts including full removal of lesion and partial recovery of lesion, which is more than 75%, respectively.If the recovery is less than 75% during the treatment period of 6 weeks, no improvement or treatment failure will be considered.The secondary outcome is side effects leading to complications including pain, irritation, and ulcer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011531949N1
Registration date: 2017-03-05, 1395/12/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-05, 1395/12/15
Registrant information
Name
Shadab Shahali
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 614 1895
Email address
shadab.shahali@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Shallomin( a pure fraction of shallot extract) and Podophyllin solution 25% in treatment of genital HPV warts in women
Public title
Comparing the effects of Shallomin and Podophyllin solution 25% in treatment of genital HPV warts in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: genital HPV warts under 2cm exclusion criteria:age under 15; breast feeding; pregnancy
Age
From 15 years old
Gender
Female
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)
Single 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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.AJUMS.REC.1395.662

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
Tratment of genital warts
Timepoint
6 week later
Method of measurement
Visit with dermatologist

Secondary outcomes

empty

Intervention groups

1

Description
In the first group, shalomin will be used for treatment, using an applicator to apply it on the lesion. Preparation of medicines: To develop pure fractions of shallot, tuber roots of the plant in the spring of Sardasht Heights is located at 50 kilometers north of Dezful will be collected. The plant's underground tubers will wash well and then crushed in a mortar Electric will be well. 100 g of crushed plants mixed with 200 ml of distilled water for 30 minutes will be severely shaken. Isolated extract from yellow to help filter paper pulp will be removed. This is repeated three times until all the juice from the pulp will be removed. Extracts obtained in a large human gathering in the oven at 45 ° C and condensed and column chromatography on silica gel stationary phase is passed. as a medicine for the treatment of genital warts caused by the human papillomavirus used to rest. It called Shallomin at the patent office called the doctor Mansour Amin as antimicrobial have been registered.
Category
Treatment - Drugs

2

Description
In the second group podophyllin solution, 25% is applied with an applicator on the lesion. Before using the drug the surrounding of the lesion is coated with zinc oxide cream. Patients were advised to wash the place after 4 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam khomeini hospital
Full name of responsible person
Street address
Imam Khomeini hospital, Azadegan road, Ahvaz, Khuzestan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Makhmal zade
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
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, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Shadab Shahali
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3373 8189
Fax
Email
shahali-sh@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Shadab Shahali
Position
PhD
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3373 8189
Fax
Email
shahali-sh@ajums.ac.ir
Web page address

Person responsible for updating data

Contact

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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