]>
IRCT2016062128574N1 IRCT 2016-07-02 Vice chancellor for research, Iran University of Medical Sciences Comparison of the effects of Evening Primrose and Vitamin B6 on the severity of mastalgia associated with fibrocystic breast changes. FCC - EPO Comparison of the effects of Evening Primrose and Vitamin B6 on the severity of mastalgia associated with fibrocystic breast changes. 2016-07-22 anticipated 96 Complete https://irct.ir/trial/23159 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization: Sample allocation in the case and control group will be conducted randomly and using lottery through numbering 1, 2 and 3 on the cards. The samples will be asked to pick a card. By choosing a card, randomly the sample will be placed in one of the following groups: Group Evening Primrose (2 capsules 1000 mg daily), Vitamin B6 (2 capsules 50 mg daily) and placebo groups (2 capsules daily) Blinding:the medicine (Evening Primrose and Vitamin B-6) and placebo in the form of similar capsules will be produced by pharmacology advisor. Also putting capsules in the same containers and coding them will be performed by him. And at the end of the study and after analyzing the results, the capsule containers will be decoded. Thus, the samples are not aware of the contents of the medicine containers. As well as researchers and statistical analysts are not aware of the contents of the medicine containers and each groups What medications are taking. So, the study is a triple-blind. N/A Fibrocystic changes of breast. Intervention 1: Intervention group: Evening Primrose group 2 capsules 1000 mg daily for 3 months, the Vitamins B 6 group, 2 capsules 50 mg daily for 3 months, Evening Primrose is made Barij, Vitamin B6 capsules made Shahid Beheshti University of Medical Science in the School of Pharmacy. Intervention 2: Control group: placebo 2 capsules daily for 3 months Placebo capsules, made School of Pharmacy Shahid, Beheshti University of Medical Sciences.
public Rojin Tolouei
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2885 tolouei.roj@gmail.com; toloei.r@tak.iums.ac.ir Iran University of Medical Sciences, School of Nursing and Midwifery scientific Fereshteh Jahdi
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2885 jahdi_fr@yahoo.com University of Medical Sciences Iran, School of Nursing and Midwifery Iran (Islamic Republic of) Inclusion criteria : Iranian women aged 18 to 50 years before menopause; non-pregnant women; non-lactating women; women with mastalgi; rejection of cancer and other breast diseases based on clinical and laboratory evidence by specialist in surgery and breast diseases; not taking medications to reduce pain (eg Danazol, Tamoxifen, Bromocriptine) during the past three months. Exclusion criteria: pregnancies; physical or mental illness during intervention; taking any herbal or chemical or hormonal drugs during the study; unwillingness to continue taking the medication as directed; no medicine use more than 5 days 18 years 49 years Female N60 Benign mammary dysplasia Placebo Placebo Intervention group: Evening Primrose group 2 capsules 1000 mg daily for 3 months, the Vitamins B 6 group, 2 capsules 50 mg daily for 3 months, Evening Primrose is made Barij, Vitamin B6 capsules made Shahid Beheshti University of Medical Science in the School of Pharmacy Control group: placebo 2 capsules daily for 3 months Placebo capsules, made School of Pharmacy Shahid, Beheshti University of Medical Sciences The severity of mastalgia. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Visual analog scale questionnaires. Number of days with pain. Timepoint: Before the intervention, one month and two months and three months after intervention. Method of measurement: Daily record pain questionnaire. Vice chancellor for research, Iran University of Medical Sciences Approved 2016-06-12 Ethics committee of Iran University of Medical Sciences School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran Tehran Iran (Islamic Republic of)