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Study on effects of black seed oil in treatment of cyclic mastalgia

Phase 2
Conditions
Mastalgia.
Mastodynia
Registration Number
IRCT201506132288N8
Lead Sponsor
ACECR Institute of Medicinal Plants
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
150
Inclusion Criteria

Iranian outpatient females with cyclic mastalgia, patients aged 25-45 years; patients with regular menstrual cycles; patients with cyclic mastalgia diagnosis based on history of cyclic mastalgia for at least the past 3 consecutive cycles, patients with pain duration of at least 7 days per month and mastalgia severity score greater than 4 on a 10 centimeter visual analogue scale requiring pharmacotherapy. Exclusion criteria: Patients receiving hormone therapy or hormonal contraceptive; patients with irregular menstrual cycles; patients with history of breast and endometrial cancer, hysterectomy and bilateral oophorectomy; pregnanct women; brest-feeding women; women planning pregnancy; women with serious health problems.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain severity score. Timepoint: Before, 1 and 2 months after beginning of the intervention. Method of measurement: 10 centimeter visual analog scale.
Secondary Outcome Measures
NameTimeMethod
Adverse drug reactions. Timepoint: 1 and 2 months after beginning of the intervention. Method of measurement: Patient report.
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