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

Phase 2

• Conditions: Cyclical breast pain.; Disorders of breast; N60-N64

• Registration Number: IRCT2013070710324N14
• Lead Sponsor: Vice chancellor for research, Tabriz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 159

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.