The effect of oral evening primrose oil capsule on sexual function and sexual quality of life of married women in reproductive ages: A double-blinded randomized placebo-controlled trial.
Exploring and determining the effects of oral evening primrose oil capsule on sexual function and sexual quality of life of married women in reproductive ages
Design
A double-blinded randomized placebo-controlled trial.
Settings and conduct
It will be a double-blind phase 1 of clinical trial. Research units will be 60 women referring to tehran Health Centers which are in reproductive age and eligible for inclusion in this study. Participants will be randomly assigned into two groups of 30 with homogeneity of age and number of deliveries. And will be assigned randomly by block randomization. The control group will receive placebo capsules and the intervention group will receive evening primrose oil capsule orally for 8 weeks. The tutorial will provide to participants including how to use tablets. In the control group, placebo capsules containing 1000 mg of edible paraffin which will be administered orally daily for 8 weeks. Participants' contact numbers and addresses will be recorded for access to the samples and follow-up assessments, and the researcher's contact number will also be available to answer participants' questions.
Participants/Inclusion and exclusion criteria
Iranian reproductive aged women (18-49 years old ) who have no allergy to evening primrose oil capsule.
Intervention groups
Intervention group:30 women who will receive 1 tablets of evening primrose oil capsule 1000 mg daily for 8 weeks orally. Control group: 30 women who will receive 1tablets of evening primrose oil capsule 1000 mg daily for 8 weeks orally.
Main outcome variables
Sexual function; Sexual quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045517N1
Registration date:2020-09-18, 1399/06/28
Registration timing:retrospective
Last update:2020-09-18, 1399/06/28
Update count:0
Registration date
2020-09-18, 1399/06/28
Registrant information
Name
Shadi Torkan
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 7749 2509
Email address
shaditorkan@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral evening primrose oil capsule on sexual function and sexual quality of life of married women in reproductive ages: A double-blinded randomized placebo-controlled trial.
Public title
The effect of oral evening primrose oil capsule on sexual function of women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women over the age of 18 (age 18 is considered a good time for marriage) and before the age of pre-menopause (49 years).
Being Iranian and living in Tehran
Reading and Writing Persian Language
participants who had a monogamous husband during the study and at the beginning of it
Having sex in the last two months
Exclusion criteria:
Having a known underlying disease
Couples are addicted to drugs and alcohol
Having a history of pelvic surgery
pregnancy or breastfeeding
Having a mental illness
Sensitive to evening primrose oil
Taking drugs that affect sexual function
Have a stressful accident over the past month
Have a urinary tract infection
Having vaginitis, cervicitis, pelvic genital pain disorders, active sores or genital lesions that interfere with sexual intercourse (penetration)
Victims of rape
having the history of infertility
Age
From 18 years old to 49 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be use for randomizing participants within blocks such that an equal number will assigned to treatment. we will give a block size of 4, which there are 6 possible ways to equally assign participants to a block. Allocation proceeds by randomly selecting one of the orderings and assigning the next block of participants to study groups according to the specified sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher and the study participants will not aware of the drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modarres University
Street address
Faculty of Medicine, Tarbiat Modares University, Jalal al Ahmad high way
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2019-07-17, 1398/04/26
Ethics committee reference number
IR.MODARES.REC.1398.141
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Female sexual function
Timepoint
Evaluation of research units will be done 4 and 8 weeks after the intervention.
Method of measurement
Female sexual function index
2
Description
Sexual Quality of Life
Timepoint
Evaluation of research unitswill be don 4 and 8 weeks after the intervention
Method of measurement
Sexual Quality of Life-Female (SQOL-F) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 women who will be included in the study according to inclusion criteria. They will consume 1 capsule of 1000 mg oral evening primrose oil daily prepared by barij esans Company for 8 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the evening primrose oil capsule. Evaluation of the research units will be done 4 weeks after the intervention using the questionnaires completed by the research units in person.
Category
Treatment - Drugs
2
Description
Control group: 30 women who will be included in the study according to inclusion criteria. They will consume 1placebo capsule of 30 mg daily prepared by barij esans Company for 8 weeks. Following the intervention, the researcher will contact the research units in the intervention group each week to ensure proper use of the placebo capsule. Evaluation of the research units will be done 4 weeks after the intervention using the questionnaires completed by the research units in person.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Health Centers
Full name of responsible person
Shadab Shahali
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3811
Email
shaditorkan@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Fathollahi Yaghoub
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4230
Fax
+98 21 8288 4230
Email
shaditorkan@modares.ac.ir
Web page address
http://www.modares.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Shadab Shahali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3811
Email
shadab.shahali@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Shadab Shahali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3811
Email
shadab.shahali@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shadab Shahali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Jalal al Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3811
Email
shadab.shahali@modares.ac.ir
Web page address
http://www.modares.ac.ir/en
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only the main outcome will be published.
When the data will become available and for how long
The main outcome will be available after 2021
To whom data/document is available
The data will be available for college researchers
Under which criteria data/document could be used
For more research, researchers could send their request letter to the co respond anther.
From where data/document is obtainable
Correspondence Author. Department of Reproductive Health and Midwifery, Faculty of Medical Sciences, Tarbiat Modares University.
What processes are involved for a request to access data/document
Upon receiving the request letter by the coresponding author, the request will be forwarded to Tarbiat Modarres University Research Unit, and the analyzed data will be send to researchers if applicable.