To asses the effect of oral zinc sulphate in clearance of cervical human papilloma virus(HPV)
To asses the effect of oral zinc sulphate in clearance of cervical human papilloma virus(HPV) and age
To asses the effect of oral zinc sulphate in clearance of cervical human papilloma virus(HPV) and OCP
To asses the effect of oral zinc sulphate in clearance of cervical human papilloma virus(HPV) and smoking
Design
Clinical trials with cotrol group, non randomised with blinded postoperative care and outcome assessment
Settings and conduct
Gynecology clinic of motahari hospital
Participants/Inclusion and exclusion criteria
Including criteria are the following having a positive HPV DNA test and pap smear cytology report of either ACUS or LSIL. patients with abnormal serum zinc level, ongoing pregnancy, breast feeding, immune compromised state diagnosis and perior history of cone biopsy were excluded from study.
Including criteria are the following having a positive HPV DNA test and pap smear cytology report of either ACUS or LSIL. patients with abnormal serum zinc level, ongoing pregnancy, breast feeding, immune compromised state diagnosis and perior history of cone biopsy were excluded from study.
Intervention groups
According to previous studies, based on the fact that zinc has a strengthening effect on the immune system, in some studies it has caused viral clearance and wart healing. In our study, patients who have an abnormal Pap smear or a positive viral genome and their serum levels are normal will be given oral zinc sulfate capsules and will have another Pap smear and viral genome re-examined three months later. We will not have therapeutic intervention in the control group and will be re-examined and compared with the intervention group three months later.
Main outcome variables
clearance of cervical human papilloma virus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210407050882N1
Registration date:2021-04-15, 1400/01/26
Registration timing:registered_while_recruiting
Last update:2021-04-15, 1400/01/26
Update count:0
Registration date
2021-04-15, 1400/01/26
Registrant information
Name
Naghme Zandvakili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3366 4468
Email address
zandvakilinaghme@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of oral zinc sulphate supplement on clearance of cervical human papilloma virus
Public title
Effect of zinc sulphate in papilloma virus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positive HPV DNA test
LSIL in pap smear
Ascus in pap smear
Exclusion criteria:
Pregnancy
Breast feeding
Immunocompromised state deasie
Perior history of cervical cone biopsy or LEEP
Age
From 21 years old to 55 years old
Gender
Female
Phase
1-2
Groups that have been masked
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Tha research is blind and given oral zinc sulphate tables by the clinical caregiver on even days,and the individual day patients place in the control group.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of medical sciences
Street address
Urmia, Emergency Ave , Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
3457871437
Approval date
2018-12-12, 1397/09/21
Ethics committee reference number
IR.UMSU.REC.1397.366
Health conditions studied
1
Description of health condition studied
Abnormal papsmear and cervical cytology
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Effect of oral zinc sulphat(in department variable)in clearance of cervical human papilloma virus (dependent variable)
Timepoint
Both groups check their serum zinc levels at start and the end of study,which is before the star of zinc supplement and 30 days after the last dose of zinc for intervention group.Than in both groups do pap smear and cervical HPV typing.
Method of measurement
Repeat pap smear and HPV typing in same laborator
Secondary outcomes
empty
Intervention groups
1
Description
Control group:no medication
Category
Other
2
Description
Intervention group: Before starting the study, the subject of research on the relationship between serum zinc levels and the possibility of purification of cervical human papilloma virus and effect and probably side effects of zinc sulphate supplement explain to all patients and with knowledge and cosent enter the study.Than given zinc sulphate capsule 220 mg (zinc 50 mg) twice a day for three months.cap zinc sulphate 220 mg 7H20 made in iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid motahari hospital
Full name of responsible person
Naghme zandvakili
Street address
No .1, kashani Ave
City
Urmia
Province
West Azarbaijan
Postal code
1546357146
Phone
+98 44 2223 2007
Email
Zandvakilinaghme@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Yekta
Street address
No.1 ,Khashani Ave
City
Urmia
Province
West Azarbaijan
Postal code
6417536451
Phone
+98 44 2223 2007
Email
zandvakilinaghme@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Naghme zandvakili
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.44 , modiriat Ave
City
Urmia
Province
West Azarbaijan
Postal code
5719177616
Phone
+98 44 3366 4468
Email
zandvakilinaghme@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hale Ayatollahi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No,7. Daneshkade Ave
City
Urmia
Province
West Azarbaijan
Postal code
5719177619
Phone
+98 44 3357 2631
Email
elham.rjb68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Elham rajabi
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.1, Roudaki Ave
City
Urmia
Province
West Azarbaijan
Postal code
5719177616
Phone
+98 44 3366 4468
Email
elham.rjb68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available