To determine the effectiveness of evening primrose oil supplements on menopausal symptoms
Design
Clinical trials with drug and placebo control group, treatment-based, with parallel groups, blind, randomized by block method
Settings and conduct
This is a clinical trial study on women with menopausal symptoms referred to gynecological clinics of Khaleej-e-fars hospital in Bandar Abbas. Participants will be randomly divided into two groups. One group will receive evening primrose oil oral supplementation and the other group will receive placebo. All participants will be blind to type of treatment. Two months later, menopausal symptoms will be evaluated by Menopausal Rating Scale.
Participants/Inclusion and exclusion criteria
Women with menopausal symptoms who will be referred to gynecological clinics of Khaleej-e-fars hospital in Bandar Abbas
Intervention groups
Participants will be randomly divided into 2 groups A and B. To group A, evening primrose oil supplementation will be provided from Nature Life factory manufactured in Canada with a dose of 1000 mg/d for 8 weeks. Group B will be given a placebo.
Main outcome variables
Menopausal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181107041585N2
Registration date:2019-03-11, 1397/12/20
Registration timing:registered_while_recruiting
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Fatemeh Darsareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3355 4515
Email address
famadarsareh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral consumption of evening primrose oil on menopausal symptoms in 45-60 years old menopausal women
Public title
Effect of oral consumption of evening primrose oil on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45 and 60 years old
Married
12 months amenorrhea
Normal pap smear in past12 months
Normal finding in physical examinations
Exclusion criteria:
serious chronic medical conditions
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple Random unit: Individual Randomization Tool: Sealed Envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the allocation, the pills will be divided into the opaque A and B packets and numbered. Participant, clinical caregiver, researcher, and outcome evaluator will be unaware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Bagh Monir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.HUMS.REC.1397.314
Health conditions studied
1
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Menopausal symptoms score
Timepoint
Before intervention and at the end of second month of intervention
Method of measurement
Menopausal Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: evening primrose oil 1000 milligram every day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: consumption of placebo every day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khaleej Fars hospital
Full name of responsible person
Fatemeh Darsareh
Street address
Bagh Monir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3355 4515
Email
famadarsareh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Street address
Bagh Monir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3355 4515
Email
famadarsareh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bagh Monir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3355 4515
Email
famadarsareh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bagh Monir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3355 4515
Email
famadarsareh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fatemeh Darsareh
Position
Midwife
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Bagh Aonir st. Amir Abad
City
Bandar Abbas
Province
Hormozgan
Postal code
7918796758
Phone
+98 76 3355 4515
Email
famadarsareh@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