The purpose of this study is to evaluate the effect of flaxseed oil for relief the symptoms of premenstrual syndrome. The study is a randomized, double-blind which will be carried out on 118 patients with premenstrual dysphoric disorder referred to Ziaeian Hospital. The study will be conducted on women 18 to 35 years with premenstrual dysphoric complaint that not received any other drugs and effective supplements on premenstrual syndrome 2 months before intervention and have no other mental or physical illness during 3 months before study and will be excluded if side effects and drug intolerance occurs. Method: With simple randomization, patients will be divided into 2 groups: intervention group (flaxseed oil soft gel) and control group (placebo soft gel). All patients will receive flaxeed oil or placebo soft gel over 3 menstrual cycles from 7 days before starting cycle for 14 days twice a day. Response to treatment and possible side effects are examined by the relevant questionnaire. All patients and researchers are blinded to the study groups and information on groups studied will be specified at the end of the study and statistical analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040227170N1
Registration date:2017-06-27, 1396/04/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Fatemeh Nejatbakhsh
Name of organization / entity
medical University Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6675 4151
Email address
nejatbakhsh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran university School of Traditional Medicine
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of flaxseed oil compared with placebo on premenstrual dysphoric disorder: a double-blind randomized controlled clinical trial
Public title
The effect of flaxseed oil on premenstrual dysphoric disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 and 35; Regular menstrual cycles (21-35 days) in the past two months; No smoking, tobacco and drugs; Have premenstrual dysphoric disorder according to PSST questionnaire; No use of other drugs and effective supplementation on premenstrual syndrome for 2 months before intervention; Not taking oral contraceptives; No history of psychiatric drugs and psychotropic substances in the past 6 months; No history of physical or mental illness during 3 months before study; No depression based on the SCL-90-R; No stress in the last three months like dead relatives or marriage or surgery, No pregnancy; No lactating
Exclusion criteria: consumption of other drugs and supplements effective in the treatment of premenstrual syndrome during study; oral contraceptive pills during intervention; Report any allergies or side effects during the study; Inappropriate use of drugs; get pregnant; Cancel study
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, near Quds St., Keshavarz Ave.
City
Tehran
Postal code
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.TUMS.REC.1394.1576
Health conditions studied
1
Description of health condition studied
Premenstrual dysphoric disorder
ICD-10 code
F32.81
ICD-10 code description
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual
Primary outcomes
1
Description
Premenstrual dysphoric disorder severity
Timepoint
before and during the three months of intervention
Method of measurement
PSST questionnaire
Secondary outcomes
1
Description
Response to treatment
Timepoint
After intervention
Method of measurement
CGI-I questionnaire
2
Description
Patient satisfaction
Timepoint
After intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
All patients in first intervention group, taking Flaxseed oil soft gel over three menstrual cycles from 7 days before starting cycle for 14 days, fasting and before sleep
Category
Treatment - Drugs
2
Description
All patients in second intervention group, taking placebo soft gel over three menstrual cycles from 7 days before starting cycle for 14 days, fasting and before sleep
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's clinic of Ziaeian Hospital
Full name of responsible person
Street address
Opposite municipality 17, 20 m Abuzar, Abuzar Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran university School of Traditional Medicine
Full name of responsible person
Roja Rahimi
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
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 Tehran university School of Traditional Medicine
Proportion provided by this source
100
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
Tehran University of medical sciences
Full name of responsible person
Fereshteh Ghorat
Position
PhD
Other areas of specialty/work
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Postal code
Phone
+98 21 8899 0837
Fax
Email
ghorat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of medical sciences
Full name of responsible person
Fatemeh Nejatbakhsh
Position
Assistant Professor
Other areas of specialty/work
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Postal code
Phone
+98 21 8899 0837
Fax
Email
Nejatbakhsh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Nejatbakhsh
Position
PhD
Other areas of specialty/work
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Postal code
Phone
+98 21 8899 0837
Fax
Email
nejatbakhsh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)