In this study, patients with polycystic ovary syndrome are randomly divided into two groups: metformin and inofollic. After three months receiving the medication, the amount of homocysteine and their oxidative stress factors are compared. The patient and the investigator are not aware of the type of drug used.
Participants/Inclusion and exclusion criteria
The inclusion criteria PCO patients
The exclusion criteria diabetes mellitus, hyperprolactinemia, congenital adrenal hyperplasia, thyroid disorders, Cushing's syndrome, hypertension, folate and vitamin B12 deficiency, liver and kidney disorders.
Intervention groups
First group of metformin, second group of inofolloic
Main outcome variables
Homocysteine, Folic Acid, Vitamin B12, Malondialdehyde, Plasma total antioxidant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190508043516N1
Registration date:2019-07-28, 1398/05/06
Registration timing:registered_while_recruiting
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Nasim Athari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3446 2568
Email address
atharinasim@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of MYO- Inositol and metformin on oxidative stress and homocysteine levels in patients with polycystic ovary syndrome
Public title
The effects of MYO- Inositol and metformin on oxidative stress and homocysteine levels in patients with polycystic ovary syndrome
Patients are randomly divided into two distinct and equal groups according to random randomization. In this way, they are divided into two groups A (metformin) and B (inofollic), and 6 blocks of 1-AABB 2-ABAB 3- ABBA 4- BBAA-5ABAB 6- BABA are considered for them, respectively, according to the incidence of patients And according to the blocks (1 to 6) received the medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient does not see the label of the drug.
The researcher does not know the type of drug patient receives.
The data analyzer does not know the patient's medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Dezful University of Medical Sciences
Street address
Dezful University of Medical Sciences, Azadegan Blvd
City
Dezful
Province
Khouzestan
Postal code
6461665145
Approval date
2018-07-27, 1397/05/05
Ethics committee reference number
IR.DUMS.REC.1397.037
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovary syndrome
Primary outcomes
1
Description
Homocysteine
Timepoint
Beginning of study, three months after the intervention
Method of measurement
Elisa kit
2
Description
Oxidative stress factors
Timepoint
Beginning of study, three months after the intervention
Method of measurement
Elisa kit
Secondary outcomes
empty
Intervention groups
1
Description
intervention group1: metformin twice a day at 850 mg for 3 months
Category
Treatment - Drugs
2
Description
Intervention group2: 4 g of Myoinositol daily with 400 μg of folic acid (inofollic) for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezful university of medical science
Full name of responsible person
Nasim Athari
Street address
Dezful university of medical science, Azadegan Blvd
City
Dezful
Province
Khouzestan
Postal code
6461665145
Phone
+98 61 4242 9780
Email
atharinasim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Aziz Kasani
Street address
Dezful medical university, Azadegan Blvd
City
Dezful
Province
Khouzestan
Postal code
6461665145
Phone
+98 61 4242 9731
Email
atharinasim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezfoul 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
Dezfoul University of Medical Sciences
Full name of responsible person
Nasim athari
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
102,West 9 Ave,tavanir street,kourosh,ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
61648 76311
Phone
+98 61 3446 2568
Email
Atharinasim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Nasim athari
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
102,West 9 Ave,tavanir street,kourosh,ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
61648 76311
Phone
+98 61 3446 2568
Email
Atharinasim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Nasim athari
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
102,West 9 Ave,tavanir street,kourosh,ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
61648 76311
Phone
+98 61 3446 2568
Email
Atharinasim@yahoo.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
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