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IRCT20170513033941N68 IRCT 2020-04-05 Kashan University of Medical Sciences Effects of melatonin supplementation in the treatment of fibrocystic changes of breast Comparing the effects of probiotic supplementation and placebo on clinical status and metabolic profiles in overweight or obese women with fibrocystic changes of breast 2020-03-05 anticipated 50 Complete https://irct.ir/trial/45770 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 50 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes, 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 Zisttakhmir 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. Participants, investigators or the assessors of the outcomes are unaware of the study groups. 3 Breast fibrocystic disease. Intervention 1: Intervention group: Probiotic capsule (Zisttakhmir Co., Tehran, Iran), including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum, once a day for 12 weeks orally. Intervention 2: Control group: Placebo capsules (Zisttakhmir Co., Tehran, Iran), once a day for 12 weeks orally. 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. Seyed Hamed Rouhani
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 rouhani.h@gmail.com Kashan University of Medical Sciences scientific Dr. Leila Ghafour
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 4446 0180 ghafour.leila@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 Unwillingness to cooperate N60 Benign mammary dysplasia Treatment - Drugs Placebo Intervention group: Probiotic capsule (Zisttakhmir Co., Tehran, Iran), including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum, once a day for 12 weeks orally. Control group: Placebo capsules (Zisttakhmir Co., Tehran, Iran), once a day for 12 weeks orally. 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. Breast Pain Severity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Visual analogue scale 0-10. 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. 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. Depression score on Beck Depression Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Anxiety score on Beck Anxiety Inventory. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Sleep Quality score on Pittsburgh Sleep Quality Index. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire. Kashan University of Medical Sciences Approved 2020-02-03 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)