Study propose: the effect of multivitamin on cervix precancerous lesion. Study design: RCT (double blind). Study Population: 120 patients with abnormal pop smear ( ASCUS, ASC-H,LSIL) and related clinical symptoms and signs at Fatemiyeh hospital. Inclusion criteria: Cervical intraepithelial Neoplasia (CIN1); Atypical cell with HPV positive. Exclusion criteria: CIN2 or more in primary pathology report after biopsy. Intervention: mineral and multivitamin and 30 mg per day Q10 during 3 mounts and plasebo for control group. Outcome: disappear of lesion in CIN1 level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102719694N1
Registration date:2015-05-10, 1394/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Azar Pirdehghan
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0572
Email address
a.pirdehghan@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2015-02-17, 1393/11/28
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cytopathologic and Colposcopic findings evaluation of supplementation therapy on cervix precancerous lesion
Public title
The effect of multivitamine on precancerous leision of cervix
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cervical intraepithelial Neoplasia (CIN1); Atypical cell with HPV positive.
Exclusion criteria:
CIN2 or more in primary pathology report after biopsy.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan university of medical sciences ethical committee
Street address
Ethical committee, Medical school, Hamadan University of medical sciences, Hamadan, Iran.
City
Hamadan
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
6367/9/35/16پ
Health conditions studied
1
Description of health condition studied
Cervix cancer
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri
Primary outcomes
1
Description
Cure of Cin1 lesion
Timepoint
Pre intervention, 6 months after trial
Method of measurement
Pathology report
Secondary outcomes
empty
Intervention groups
1
Description
Mineral and multivitamin and 30 mg per day Q10 during 3 mounts in intervention group