Objective: the aim of this study is to determine the effects of herbal and animal omega-3 fatty acid supplementation on hormonal and metabolic profiles in patients with polycystic ovary syndrome (PCOS). Study design: parallel double-blind (both patients and researchers) randomized controlled clinical trial. Inclusion criteria: patients with PCOS according to Rotterdam criteria, higher than 5 years of their disease and aged 18 to 40 years will be included in this study. Exclusion criteria: unwillingness to cooperate will be excluded in the study. Population and sample size: 105 patients with PCOS of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: patients will be assigned to receive herbal omega-3 fatty acid (flax seed oil)(intervention group: n=35) and animal omega-3 supplements (intervention group: n=35) or placebo (control group: n=35). Start and end date of intervention: 12 weeks. Outcomes: hormonal and metabolic profiles will be measeaured at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041612438N19
Registration date:2016-05-05, 1395/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and metabolic response to herbal and animal omega-3 fatty acids supplementation in women with poly cystic ovary syndrome
Public title
The efffect of herbal and animal omega-3 fatty acids on polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with PCOS according to Rotterdam criteria; higher than 5 years of their disease; aged 18 to 40 years. Exclusion criterion: unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized based on table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Postal code
Approval date
2016-03-04, 1394/12/14
Ethics committee reference number
IR.KAUMS.REC.1394.175
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Hirsutism
Timepoint
Baseline and End-of-trial
Method of measurement
Observation
2
Description
Insulin resistance
Timepoint
Baseline and End-of-trial
Method of measurement
Blood sample
3
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Blood sample
4
Description
Testosterone
Timepoint
Baseline and End-of-trial
Method of measurement
Blood sample
5
Description
Prolactin
Timepoint
Baseline and End-of-trial
Method of measurement
Blood sample
6
Description
Follicular- stimulating hormone
Timepoint
Baseline and End-of-trial
Method of measurement
Blood sample
7
Description
Acne
Timepoint
Baseline and End-of-trial
Method of measurement
Observation
8
Description
Lipid profile
Timepoint
Baseline and End-of-trial
Method of measurement
Blood sample
9
Description
Hair loss
Timepoint
Baseline and End-of-trial
Method of measurement
Observation
10
Description
DHEAs
Timepoint
Baseline and End-of-trial
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Herbal Omega-3 fatty acid capsule,2 times per day for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group 2: Fish oil Omega-3 fatty acid capsule,2 times per day for 12 weeks orally.
Category
Treatment - Drugs
3
Description
Control group:placebo capsule,2 times per day for 12 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss Laleh Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Science
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan university of Medical Science, Kashan
City
Kashan
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 of Kashan University of Medical Science
Proportion provided by this source
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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taghizadeh
Position
PhD
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mohsenta44@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taghizadeh
Position
PhD
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
mohsenta44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Mahnaz Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Km44 of Kashan - Delijan Rd., Mashhad-e- Ardehal Kashan
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)