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Protocol summary
Objective: The aim of this study is to determine the effects of melatonin supplementation on clinical status and metabolic profiles in women with breast fibrocystic disease.
Objective: The aim of this study is to determine the effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with breast fibrocystic disease.
Objective: The aim of this study is to determine the effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with breast fibrocystic disease.
هدف: هدف این مطالعه تعیین اثرات مکمل ملاتونین بر علایم بالینی و پروفایل های متابولیک در زنان مبتلا به بیماری فیبروکیستیک پستان.
هدف: هدف این مطالعه تعیین اثرات مکمل ملاتونین بر علایم بالینی و پروفایل های متابولیک در زنان چاق مبتلا به بیماری فیبروکیستیک پستان.
هدف: هدف این مطالعه تعیین اثرات مکمل ملاتونین بر علایم بالینی و پروفایل های متابولیک در زنان چاق مبتلا به بیماری فیبروکیستیک پستان.
Inclusion criteria: Women aged 18-45 years and diagnosed with fibrocystic breast disease. Patients with moderate or severe cyclic mastalgia. Exclusion criteria: 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.
Inclusion criteria: Overweight or obese women aged 18-45 years and diagnosed with fibrocystic breast disease. Patients with moderate or severe cyclic mastalgia. Exclusion criteria: 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.
Inclusion criteria: WomenOverweight or obese women aged 18-45 years and diagnosed with fibrocystic breast disease. Patients with moderate or severe cyclic mastalgia. Exclusion criteria: 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.
معیارهای ورود: زنان با تشخیص بیماری فیبروکیستیک پستان در محدوده سنی 18 تا 45 سال، بیماران با ماستالژی سیکلیک متوسط یا شدید. معیارهای خروج: بیماری های بدخیم پستان، مصرف دارو جهت کاهش درد طی 3 ماه گذشته (نظیر دانازول، تاموکسی فن، بروکریپتین)، زنان منوپوز، زنان باردار یا شیرده، بیماری های روانی، مصرف هر نوع داروی هورمونی یا داروی سداتیو گیاهی یا شیمیایی در طول مطالعه، عدم تمایل به همکاری.
معیارهای ورود: زنان چاق با تشخیص بیماری فیبروکیستیک پستان در محدوده سنی 18 تا 45 سال، بیماران با ماستالژی سیکلیک متوسط یا شدید. معیارهای خروج: بیماری های بدخیم پستان، مصرف دارو جهت کاهش درد طی 3 ماه گذشته (نظیر دانازول، تاموکسی فن، بروکریپتین)، زنان منوپوز، زنان باردار یا شیرده، بیماری های روانی، مصرف هر نوع داروی هورمونی یا داروی سداتیو گیاهی یا شیمیایی در طول مطالعه، عدم تمایل به همکاری.
معیارهای ورود: زنان چاق با تشخیص بیماری فیبروکیستیک پستان در محدوده سنی 18 تا 45 سال، بیماران با ماستالژی سیکلیک متوسط یا شدید. معیارهای خروج: بیماری های بدخیم پستان، مصرف دارو جهت کاهش درد طی 3 ماه گذشته (نظیر دانازول، تاموکسی فن، بروکریپتین)، زنان منوپوز، زنان باردار یا شیرده، بیماری های روانی، مصرف هر نوع داروی هورمونی یا داروی سداتیو گیاهی یا شیمیایی در طول مطالعه، عدم تمایل به همکاری.
Intervention group: 6 mg/day melatonin supplement (Webber Naturals, Coquitlam, Canada), one hour before bedtime for 12 weeks. Control group: Placebo (Barij Essence, Kashan, Iran), one hour before bedtime for 12 weeks.
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.
Intervention group: 610 mg/day melatonin supplement (Webber NaturalsZahravi, CoquitlamTabriz, CanadaIran), one hour before bedtime for 12 weeks. Control group: Placebo (Barij Essence, Kashan, Iran), one hour before bedtime for 12 weeks.
گروه مداخله: 6 میلی گرم در روز مکمل ملاتونین (وبرنچرالز، کانادا)، یک ساعت قبل از خواب برای 12 هفته. گروه کنترل: قرص پلاسبو (باریج اسانس، کاشان، ایران)، یک ساعت قبل از خواب برای 12 هفته.
گروه مداخله: 10 میلی گرم در روز مکمل ملاتونین (زهراوی، تبریز، ایران)، یک ساعت قبل از خواب برای 12 هفته. گروه کنترل: قرص پلاسبو (باریج اسانس، کاشان، ایران)، یک ساعت قبل از خواب برای 12 هفته.
گروه مداخله: 610 میلی گرم در روز مکمل ملاتونین (وبرنچرالززهراوی، کاناداتبریز، ایران)، یک ساعت قبل از خواب برای 12 هفته. گروه کنترل: قرص پلاسبو (باریج اسانس، کاشان، ایران)، یک ساعت قبل از خواب برای 12 هفته.
General information
بررسی اثر مکمل ملاتونین در زنان مبتلا به بیماری فیبروکیستیک پستان
بررسی اثر مکمل ملاتونین در درمان بیماری فیبروکیستیک پستان
بررسی اثر مکمل ملاتونین در زنان مبتلا بهدرمان بیماری فیبروکیستیک پستان
Effects of melatonin supplementation on clinical status and metabolic profiles in women with fibrocystic breast disease
Effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with fibrocystic breast disease
Effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with fibrocystic breast disease
بررسی اثر مکمل ملاتونین بر علایم بالینی و پروفایل های متابولیک در زنان مبتلا به بیماری فیبروکیستیک پستان
بررسی اثر مکمل ملاتونین بر علایم بالینی و پروفایل های متابولیک در زنان چاق مبتلا به بیماری فیبروکیستیک پستان
بررسی اثر مکمل ملاتونین بر علایم بالینی و پروفایل های متابولیک در زنان چاق مبتلا به بیماری فیبروکیستیک پستان
Patients aged 18-45 years
women diagnosed with fibrocystic breast disease
having moderate or severe cyclic mastalgia
Patients aged 18-45 years
women diagnosed with fibrocystic breast disease
having moderate or severe cyclic mastalgia
BMI ≥ 25
Patients aged 18-45 years women diagnosed with fibrocystic breast disease having moderate or severe cyclic mastalgia BMI ≥ 25
بیماران 45-18 ساله
زنان مبتلا به بیماری فیبروکیستیک پستان
داشتن ماستالژی سیکلیک شدید یا متوسط
بیماران 45-18 ساله
زنان مبتلا به بیماری فیبروکیستیک پستان
داشتن ماستالژی سیکلیک شدید یا متوسط
شاخص توده بدنی بالاتر از 25
بیماران 45-18 ساله زنان مبتلا به بیماری فیبروکیستیک پستان داشتن ماستالژی سیکلیک شدید یا متوسط شاخص توده بدنی بالاتر از 25
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 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.
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.
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<2530 and ≥2530 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.
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<25 و ≥25 کیلوگرم بر متر مربع) و سن (<30 و ≥30) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<30 و ≥30 کیلوگرم بر متر مربع) و سن (<30 و ≥30) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
برای کاهش اثرات مخدوش کنندگی بالقوه، همه شرکت کنندگان بر اساس نمایه توده بدنی (<2530 و ≥2530 کیلوگرم بر متر مربع) و سن (<30 و ≥30) تصادفی سازی لایه ای خواهند شد. سپس، افراد در هر بلوک به طور تصادفی به دو گروه برای دریافت مکمل یاری یا پلاسبو تخصیص داده می شوند. تصادفی سازی با استفاده از نرم افزار کامپیوتری انجام خواهد شد.
Intervention groups
#1
Intervention group: 6 mg/day melatonin supplement (Webber Naturals, Coquitlam, Canada), one hour before bedtime for 12 weeks.
Intervention group: 10 mg/day melatonin supplement (Zahravi, Tabriz, Iran), one hour before bedtime for 12 weeks.
Intervention group: 610 mg/day melatonin supplement (Webber NaturalsZahravi, CoquitlamTabriz, CanadaIran), one hour before bedtime for 12 weeks.
گروه مداخله: 6 میلی گرم در روز مکمل ملاتونین (وبرنچرالز، کانادا)، یک ساعت قبل از خواب برای 12 هفته.
گروه مداخله: 10 میلی گرم در روز مکمل ملاتونین (زهراوی، تبریز، ایران)، یک ساعت قبل از خواب برای 12 هفته.
گروه مداخله: 610 میلی گرم در روز مکمل ملاتونین (وبرنچرالززهراوی، کاناداتبریز، ایران)، یک ساعت قبل از خواب برای 12 هفته.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with breast fibrocystic disease.
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30).
Settings and conduct
Among patients with fibrocystic breast disease referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. intervention period: 12 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Overweight or obese women aged 18-45 years and diagnosed with fibrocystic breast disease. Patients with moderate or severe cyclic mastalgia. Exclusion criteria: 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.
Intervention groups
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.
Main outcome variables
Outcomes: Breast Pain Severity and hs-CRP (primary outcomes) and biomarkers of oxidative stress, parameters of mental health, glucose metabolism indices (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N59
Registration date:2019-05-27, 1398/03/06
Registration timing:registered_while_recruiting
Last update:2019-06-30, 1398/04/09
Update count:1
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of melatonin supplementation on clinical status and metabolic profiles in overweight or obese women with fibrocystic breast disease
Public title
Effects of melatonin supplementation in the treatment of fibrocystic breast disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-45 years
women diagnosed with fibrocystic breast disease
having moderate or severe cyclic mastalgia
BMI ≥ 25
Exclusion criteria:
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.018
Health conditions studied
1
Description of health condition studied
breast fibrocystic disease
ICD-10 code
N60
ICD-10 code description
Benign mammary dysplasia
Primary outcomes
1
Description
Breast Pain Severity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Visual analogue scale 0-10
2
Description
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
Secondary outcomes
1
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Beck Depression Inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
5
Description
Beck Anxiety Inventory
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
6
Description
Pittsburgh Sleep Quality Index
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Questionnaire
7
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
11
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Intervention groups
1
Description
Intervention group: 10 mg/day melatonin supplement (Zahravi, Tabriz, Iran), one hour before bedtime for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), one hour before bedtime for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Clinic
Full name of responsible person
Dr. Hossein Sadeghi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Fax
Email
sadeghi.h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
banafshe-h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hossein Sadeghi
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
sadeghi.h@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hossein Sadeghi
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
sadeghi.h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hossein Sadeghi
Position
Resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
sadeghi.h@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available