Skip to content

The effect of flaxseed oil on premenstrual dysphoric disorder

The effect of flaxseed oil compared with placebo on premenstrual dysphoric disorder: a double-blind randomized controlled clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016040227170N1
Enrollment
118
Registered
2017-06-27
Start date
2017-07-06
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual dysphoric disorder. An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual

Interventions

Intervention 1: 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. Interventio
Treatment - Drugs
Placebo
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
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

Sponsors

Vice Chancellor for research of Tehran university School of Traditional Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Premenstrual dysphoric disorder severity. Timepoint: before and during the three months of intervention. Method of measurement: PSST questionnaire.

Secondary

MeasureTime frame
Response to treatment. Timepoint: After intervention. Method of measurement: CGI-I questionnaire.;Patient satisfaction. Timepoint: After intervention. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshteh Ghorat

Tehran University of medical sciences

ghorat@yahoo.com+98 21 8899 0837

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026