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The effect of Vitex agnus-castus and Flaxseed on duration and severity of breast pain in women with cyclical mastalgia.

The effect of Vitex agnus-castus and Flaxseed on duration and severity of breast pain in women with cyclical mastalgia: A randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013070710324N14
Enrollment
159
Registered
2013-12-09
Start date
2013-10-23
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

Cyclical breast pain. Disorders of breast

Interventions

Intervention 1: The control group will receive 25 gr placebo of flaxseed daily and placebo tablet of vitex agnus twice a day for two menstrual cycles. Intervention 2: The first intervention group wil
Placebo
Treatment - Drugs
The control group will receive 25 gr placebo of flaxseed daily and placebo tablet of vitex agnus twice a day for two menstrual cycles.
The first intervention group will recieve tablet of vitex agnus made by Goldaru pharmaceutical company in Esfahan (contain 3.2- 4.8 mg dry extract of vitex fruit, equal 0.42-0.58 mg Aucubin) twice a d
The second intervention group will recieve 25 grams of flaxseed powder in a cup of water daily plus placebo tablet of vitex agnus twice a day for two menstrual cycles.

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Complaint of cyclical breast pain and tenderness; aged 18 to 45 years; Not currently taking hormonal contraception; having regular menstrual cycles (cycles 22 to 35 days) in the last 6 months; having a phone number for following; willingness to participate in study and having informed consent; being literate; cyclical breast pain and pain severity score above 7 according to chart Cardiff. Exclusion criteria: History of breast cancer; History of injury or wound in breast; using of medications that affect on breast pain (anti-depressants, digoxin, methyldopa, spironolactone, Chlorpropamide, danazol and tamoxifen); existence of lump or abnormalities in breast examination; existence of non cyclical breast pain or pain originates outside of the breast; history of asthma or allergies; taking dopamin agonist and antagonist (Levodopa, Amphetamine, Amphetamine, pergolide, Cabergoline, metoclopramide) in the last 6 months; history of breast cancer and other cancers in first-degree relatives; existence of known uterine myoma.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Duration and severity of breast pain. Timepoint: Before intervention, 1 and 2 months after intervention. Method of measurement: Cardiff chart.

Secondary

MeasureTime frame
Menstrual bleeding. Timepoint: Before intervention, 1 and 2 months afterintervention. Method of measurement: Higham chart.;Perimenstrual symptoms. Timepoint: Before intervention, 1 and 2 months after intervention. Method of measurement: Shortened premenstrual assessment form.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmadpur Parivash

Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences

p.ahmadpor_68@yahoo.com+98 42 6333 0715

Outcome results

None listed

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