The aim of this study was to evaluate the effect of cream containing turmeric extract on female genital warts.
Design
This study is a double-blind and controlled trial, 30 patients with genital warts are assigned in each group. In order to apply the concealment in the randomization process, unique codes will be used on the drug boxes.
Settings and conduct
All patients referred to Imam Khomeini Hospital of Abadan, Iran, were assigned randomly in one of the treatment regimens for 2 weeks.
Participants/Inclusion and exclusion criteria
Age over 4 years, no pregnancy and lactation, patient satisfaction and genital warts
Dermatology life quality index
Size of warts
Number of warts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111105008013N10
Registration date:2020-11-23, 1399/09/03
Registration timing:retrospective
Last update:2020-11-23, 1399/09/03
Update count:0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Amir Siahpoosh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 2197
Email address
siahpoosh-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-08-26, 1399/06/05
Actual recruitment start date
2020-05-02, 1399/02/13
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-08-22, 1399/06/01
Scientific title
Double-blind, placebo-controlled clinical terial on efficacy of cream of turmeric extract on genital warts of women
Public title
clinical terial on efficacy of cream of turmeric extract on genital warts of women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age over 4 years old
Patient satisfaction
No pregnancy and lactation
Having genital warts
Exclusion criteria:
wounds contaminated with excess materialspatients taking immune suppressive drugs such as corticosteroids , chemotheraputic drugs or undergoing radiation therapy
patients suffering from immune deficiency-associated diseases such as diabetes, cancer, or any metabolic disease
patients suffering from any symptomatic infection
Age
From 4 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with quadruple blocks. blocks are produced by use of the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
Unique codes, which is generated by the software, will be used on the drug boxes. By entering each individual into the study based on the produced sequence, the drug box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups
Placebo
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
Esfand St., Farvardin Blvd., Golestan
City
ahvaz
Province
Khouzestan
Postal code
6135733184
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.AJUMS.REC.1398.973
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
Dermatology life quality index
Timepoint
At the intervention begining, 7 and 14
Method of measurement
Dermatology life quality questionnaire
2
Description
Score in the Genital Wart Questionnaire
Timepoint
At the intervention begining, 7 and 14
Method of measurement
Genital warts questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cream containing turmeric extract (4 %), 3 times a day for one week
Category
Treatment - Drugs
2
Description
Control group: Cream containing synthetic allowed dyes,3 times a day for one week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology ward of Imam Khomeini Hospital in Abadan
Full name of responsible person
Amir Siahpoosh
Street address
Medicinal Plants Research Center and Deparment of Pharmacognosy, Faculty of Pharmacy, Ahvaz Jundishapur University of medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Amirsiahpoosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr mehdi ahmadi moghadam
Street address
Esfand Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Amirsiahpoosh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-a@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of data will be shared
When the data will become available and for how long
The access period will be 6 months after the publication of the results
To whom data/document is available
The information obtained will only be available to researchers working in universities and science centers
Under which criteria data/document could be used
Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis
From where data/document is obtainable
Applicants can be contacted with corresponding author by e-mail
What processes are involved for a request to access data/document
Applicants will be able to access the obtained data from the current study by sending an email to the corresponding author up to one month