Comparison effect of flaxseed dietary and supplementary of omega-3fatty acid on cyclical mastalgia intensity among referring women to hospitals of Shiraz university of medical sciences 2012-2013
Mastalgia is one of the common complaints in women. Mild premenstrual breast pain that lasts less than 5 days is considered normal, but mastalgia with more intensity or duration can interfere with daily activities of life and sexual function and needs for treatment. Since the chemical drugs have serious side effects, herbal therapy and alternative medicine research is necessary. Due to antioxidant and hormonal potential effects of flaxseed, research team decided to examine the effects of flaxseed on mastalgia. Also due to antioxidant and anti- inflammatory beneficial effects of omega-3, the study will examine its effects on mastalgia, and the effectiveness will compare with flax seed effect. This study is a randomized clinical trial. The study population is women with moderate or severe mastalgia. 20-45 years old women without a history of breast and reproductive tract caners and other certain diseases will enter to this study and Allergic women to flaxseed or Omega-3 will be excluded. There are two experimental groups in this study. One group will receive 30 grams dietary flaxseed bread per day and the other group will receive one gram omega-3 per dayfor two menstrual cycles. Also a control group will receive wheat bread. After the end of every two menstrual cycles, a questionnaire will complete for each participants. The main variables that will asses are the severity and duration of mastalgia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010510327N3
Registration date:2013-07-01, 1392/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-01, 1392/04/10
Registrant information
Name
Farideh Vaziri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9131
Email address
vazirif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of flaxseed dietary and supplementary of omega-3fatty acid on cyclical mastalgia intensity among referring women to hospitals of Shiraz university of medical sciences 2012-2013
Public title
Comparison effect of flaxseed dietary and supplementary of omega-3fatty acid on cyclical mastalgia intensity among referring women to hospitals of Shiraz university of medical sciences 2012-2013
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with cyclic mastalgia; regular menstrual cycles between 24-35 days; 4 or more mastalgia pain with VAS scale; age between 20-40 years old; not breast feeding; not to get pregnant; BMI between 19 to 29; no premature menopause; no history of breast and endometrial cancer or ovarian cancer; non family history of breast cancer; no use of pharmaceutical and plant treatment during the study and no systemic disease or history of disease.
Exclusion criteria: pregnancy; starts taking any medication during the study and sensitivity or intolerance to supplements.
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commity of shiraz university of medical sciences
Street address
ZAND AVENUE
City
Shiraz
Postal code
Approval date
2013-01-26, 1391/11/07
Ethics committee reference number
91/374702
Health conditions studied
1
Description of health condition studied
Mastalgia
ICD-10 code
N64.4
ICD-10 code description
Mastodynia
Primary outcomes
1
Description
Pain intensity
Timepoint
First, second and third months.
Method of measurement
visoual analogue scale
Secondary outcomes
1
Description
Pain duration
Timepoint
First, second and third months
Method of measurement
Interview
Intervention groups
1
Description
first interventional group: the group will receive Dietary flaxseed breads. This intervention continue for two menstrual cycles
Category
Treatment - Other
2
Description
second interventional group: the group will recive omega3 for 2 menstrual cycles
Category
Treatment - Drugs
3
Description
control group: this group will recived wheat bread for two menstrual cycles
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hatam
Street address
Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Vaziri Farideh
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi sq.
City
Shiraz
Postal code
Phone
+98 71 1647 4253
Fax
Email
vazirif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Vaziri Farideh
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
vazirif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Vaziri Farideh
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
vazirif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)