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Comparison of the effect of Primerose oil and Vitamin B6 versus placebo on premenstrual syndrome in girl college students

Comparison of the effect of Primerose oil and Vitamin B6 versus placebo on premenstrual syndrome in girl college students: a double blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201610289014N127
Enrollment
120
Registered
2016-10-31
Start date
2016-11-21
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 syndrome. Premenstrual tension syndrome

Interventions

Intervention 1: Intervention group: Primerose oil capsule 1000 mg twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles. Intervention 2: Intervention gro
Treatment - Drugs
Placebo
Intervention group: Primerose oil capsule 1000 mg twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles
Intervention group: Vitamin D capsule 40 mg twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles
Control group: Placebo capsule twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles

Sponsors

Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age of 18 to 35 years; having regular menstrual cycle with 21 to 35 days interval. Exclusion criteria: physical disease or using medications; psychological disease; using anti-depression drugs during past months; using hormonal drugs or vitamins.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of symptoms of premenstrual syndrome. Timepoint: before intervention and 1 and 2 months after intervention. Method of measurement: using standard diagnostic questionnaire for premenstrual syndrome.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArezoo Shayan

School of Nursing and Midwifery

arezoo.shayan2012@yahoo.com+98 81 3838 0572

Outcome results

None listed

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