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IRCT20200205046381N1 IRCT 2020-02-28 Shahre-kord University of Medical Sciences 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 2020-03-20 anticipated 70 Complete https://irct.ir/trial/45627 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation of the participants to the intervention 1 and 2 groups will be done using random allocation software. Then, envelopes prepare according to the number of participants in the study. It will be recorded number one on the first envelope, the second envelope number 2, and etc. In each envelope, the assignment of each individual is determined by the software. In this way, the specified envelope for each individual will be opened and the individual will be assigned to one of the intervention 1 and/or intervention 2 groups according to the option recorded in the envelope, Blinding description: A B C code is required for each group. All fluoxetine, vitamin E and placebo medications are put into the same capsules by the manufacturer and the investigator and particpant are not aware of the type of drug used. 3 Mastalgia. 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: receive 600 units of vitamin E and placebo daily per oral for 8 weeks. All drugs are manufactured by Tehran Drug Company. Yes - There is a plan to make this available What will be shared: Total data in article format When: one years To whom: researchers Conditions: publication Where to obtain: journals How to obtain: publication of article Comments:
public Sheida Shabanian
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 8818718791 009832220016 shabanian@skums.ac.ir Shahre-kord University of Medical Sciences scientific Sheida Shabanian
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 818718791 +98 38 3222 0016 shabanian@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 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 20 years 50 years Female 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 N60.2 Fibroadenosis of breast Treatment - Drugs Treatment - Drugs 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 Control group: receive 600 units of vitamin E and placebo daily per oral for 8 weeks. All drugs are manufactured by Tehran Drug Company Pain. Timepoint: Baseline and two months after intervention. Method of measurement: VAS Questionaire. Shahre-kord University of Medical Sciences Approved 2019-02-03 Ethics committee of Shahrekord University of Medical Sciences Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)