Comparison of the effects of Evening Primrose and Vitamin B6 on the severity of mastalgia associated with fibrocystic breast changes.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016062128574N1

Enrollment

Registered

2016-07-02

Start date

2016-07-22

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

Fibrocystic changes of breast. Benign mammary dysplasia

Interventions

Intervention 1: Intervention group: Evening Primrose group 2 capsules 1000 mg daily for 3 months, the Vitamins B 6 group, 2 capsules 50 mg daily for 3 months, Evening Primrose is made Barij, Vitamin

Placebo

Intervention group: Evening Primrose group 2 capsules 1000 mg daily for 3 months, the Vitamins B 6 group, 2 capsules 50 mg daily for 3 months, Evening Primrose is made Barij, Vitamin B6 capsules mad

Control group: placebo 2 capsules daily for 3 months Placebo capsules, made School of Pharmacy Shahid, Beheshti University of Medical Sciences

Eligibility

Sex/Gender

Female

Age

18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : Iranian women aged 18 to 50 years before menopause; non-pregnant women; non-lactating women; women with mastalgi; rejection of cancer and other breast diseases based on clinical and laboratory evidence by specialist in surgery and breast diseases; not taking medications to reduce pain (eg Danazol, Tamoxifen, Bromocriptine) during the past three months. Exclusion criteria: pregnancies; physical or mental illness during intervention; taking any herbal or chemical or hormonal drugs during the study; unwillingness to continue taking the medication as directed; no medicine use more than 5 days

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The severity of mastalgia. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Visual analog scale questionnaires.	—

Secondary

Measure	Time frame
Number of days with pain. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Daily record pain questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRojin Tolouei

Iran University of Medical Sciences, School of Nursing and Midwifery

tolouei.roj@gmail.com; toloei.r@tak.iums.ac.ir+98 21 8888 2885

Outcome results

None listed

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