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IRCT20170513033941N59 IRCT 2019-05-27 Kashan University of Medical Sciences Effects of melatonin supplementation in the treatment of fibrocystic breast disease Effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with fibrocystic breast disease 2019-05-22 anticipated 60 Complete https://irct.ir/trial/39492 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<30 and ≥30 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the general surgery clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. 3 breast fibrocystic disease. Intervention 1: Intervention group: 10 mg/day melatonin supplement (Zahravi, Tabriz, Iran), one hour before bedtime for 12 weeks. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), one hour before bedtime for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Dr. Hossein Sadeghi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 sadeghi.h@gmail.com Kashan University of Medical Sciences scientific Dr. Hossein Sadeghi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 sadeghi.h@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-45 years women diagnosed with fibrocystic breast disease having moderate or severe cyclic mastalgia BMI ≥ 25 18 years 45 years Female Malignant breast diseases Taking medicines for reducing pain (such as danazol, tamoxifen, bromocriptine) over the past three months Menopause women Pregnant or breastfeeding women Psychological diseases The consumption of any herbal or chemical sedative or hormonal medicines during the study Unwillingness to cooperate N60 Benign mammary dysplasia Treatment - Drugs Placebo Intervention group: 10 mg/day melatonin supplement (Zahravi, Tabriz, Iran), one hour before bedtime for 12 weeks. Control group: Placebo (Barij Essence, Kashan, Iran), one hour before bedtime for 12 weeks. Breast Pain Severity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Visual analogue scale 0-10. High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Kashan University of Medical Sciences Approved 2019-05-06 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)