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Comparing the analgesic effect of fluoxetine and vitamin E with vitamin E only in breast pain due tofibrocystic breast disease

Comparing the analgesic effect of fluoxetine and vitamin E with vitamin E only in mastalgia due tofibrocystic breast disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200205046381N1
Enrollment
70
Registered
2020-02-28
Start date
2020-03-20
Completion date
Unknown
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mastalgia. Fibroadenosis of breast

Interventions

Intervention 1: Intervention group: receive 600 units of vitamin E daily and 10 mg of fluoxetine per oral for 8 weeks. All drugs are manufactured by Tehran Drug Company. Intervention 2: Control group:

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Women 20 to 50 years old with fibrocystic breast disease-induced mastalgia Women with mastalgia criterion equal to or greater than four on the VAS scale Women whose pain lasts more than 5 days per month The patient has no known history of brest disease or malignancy

Exclusion criteria

Exclusion criteria: Women with physical and mental illnesses such as polycystic ovary disease Obese female patients 30=BMI Women who have been on hormone therapy for the past three months Women who use contraceptives

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Baseline and two months after intervention. Method of measurement: VAS Questionaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSheida Shabanian

Shahre-kord University of Medical Sciences

shabanian@skums.ac.ir009832220016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Aug 12, 2026