To determine the effect of evening primrose on clinical symptoms in women with polycystic ovary syndrome
Design
Clinical trial with a control group, with parallel groups, triple blinded, randomized with blocking method, phase three on 62 patients. The randomizer software will be used for randomization.
Settings and conduct
This study will be performed in Al-Zahra, Taleghani, Imam Reza and Sina Educational-Medical Centers of Tabriz. Participants in the intervention group will receive 1000 mg evening primrose oil capsules daily and the participants in the control group will receive placebos capsule similar to the intake order for intervention group. The duration of the intervention will be 12 weeks. Hirsutism, depression and menstrual characteristics questionnaires will be completed before and after the end of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of the diagnosis of PCOS according to the criteria of Androgen Excess/PCOS Society; Minimum hirsutism score of 6 based on the Freeman Galloway criterion; Having reading and writing literacy; BMI between18.5 and 40; Not taking vitamins, minerals and omega-6 in the three months before the intervention
Exclusion criteria: Having other androgenic disorders; Cushing's syndrome; Having thyroid gland diseases; Pregnancy or breastfeeding; Infertility treatment at the time of study; Previous surgery on one or both ovaries; Consumption of pharmaceutical food supplements; Smoking and alcohol consumption; Occurrence of unfortunate events
Intervention groups
Participants in the intervention group will receive 1000 mg evening primrose oil capsules daily and the participants in the control group will receive one placebo capsule similar to the intake order for intervention group. The duration of the intervention will be 12 weeks.
Main outcome variables
Hirsutism and depression symptoms score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N73
Registration date:2022-11-08, 1401/08/17
Registration timing:registered_while_recruiting
Last update:2022-11-08, 1401/08/17
Update count:0
Registration date
2022-11-08, 1401/08/17
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-21, 1401/07/29
Expected recruitment end date
2023-04-19, 1402/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Evening Primrose Oil on Clinical Symptoms in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial
Public title
The Effect of Evening Primrose Oil on Clinical Symptoms in Women with Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the diagnosis of PCOS according to the criteria of the Androgen Excess/PCOS Society, including anovulation, chronic low ovulation, or polycystic ovaries and clinical or biochemical signs of hyperandrogenism
Minimum hirsutism score of 6 with the Freeman Galloway criterion
Having literacy to complete the questionnaires
BMI between 18.5 and 40
Ages 18-45 years
Not taking vitamins, minerals and omega-6 in the three months before the intervention
Exclusion criteria:
Having other androgenic disorders such as adrenal hyperplasia or androgen-producing tumor
Having Cushing's syndrome
Having thyroid gland diseases
Pregnancy or breastfeeding
Women undergoing infertility treatment at the time of the study
Previous surgery on one or both ovaries
Consumption of dietary supplements
Smoking and alcohol consumption
Occurrence of unfortunate events
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to two groups (one group receiving evening primrose capsules and one group receiving placebo capsules with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1. To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer software, and the evening primrose oil or placebo capsules will be placed in the same packages numbered sequentially.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2022-10-07, 1401/07/15
Ethics committee reference number
IR.TBZMED.REC.1401.599
Health conditions studied
1
Description of health condition studied
Polycystic Ovary Syndrome (PCOS)
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Hirsutism score
Timepoint
Before the intervention and after the end of intervention
Method of measurement
Ferriman – Gallwey index
2
Description
Depression symptoms score
Timepoint
Before the intervention and after the end of intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Frequency of adverse events in the study groups
Timepoint
During the intervention
Method of measurement
Researcher-made checklist
2
Description
Anthropometric indices (waist circumference, hip circumference, BMI)
Timepoint
Before and after the intervention
Method of measurement
Checklist of anthropometric indices
3
Description
Menstrual disorders
Timepoint
Before and after the intervention
Method of measurement
Menstrual characteristics questionnaire
Intervention groups
1
Description
Intervention group: For each person three matte container including 30 1000 mg evening primrose oil capsules will be prepared with a certain number. At the beginning of the study, a container including evening primrose oil will be given to the patients, and after the end of the first month, the second container will be given to the participants for consumption in the second month and the third c for container consumption in the third month will be given at the end of the second month. The treatment period will continue for three months. The intake method of evening primrose oil capsules is taking of one capsule a day with a glass of water.
Category
Treatment - Drugs
2
Description
Control group: For each person three matte container including 30 1000 mg placebo capsules will be prepared with a certain number. At the beginning of the study, a container including placebo will be given to the patients, and after the end of the first month, the second container will be given to the participants for consumption in the second month and the third c for container consumption in the third month will be given at the end of the second month. The treatment period will continue for three months. The intake method of placebo capsules is taking of one capsule a day with a glass of water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Fatemeh Nouranfar
Street address
Baghshomal
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
alzahrahospital@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Fatemeh Nouranfar
Street address
Rah-Ahan square
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3442 4423
Email
taleghani.hos@tbzmed.ac.ir.com
3
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Fatemeh Nouranfar
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
4
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Fatemeh Nouranfar
Street address
Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639889
Phone
+98 41 3541 2101
Email
sinahospital@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Research Department, third floor, Central Construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Nouranfar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5135963777
Phone
+98 41 3523 0741
Email
fateme96nour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available