The comparison of effect of Flaxseed oil and vitamin E on severity of breast pain and nodularity in women with breast fibrocystic: A randomized double blind clinical trial
Objectives: This study aims to determine the effect of Flaxseed oil on breast fibrocystic.
Design: Double blind Randomized Controlled Trial
Setting and conduct: This study will be conducted in Sari health center, Shahriar clinic. Eligible women will be selected with convenience sampling and will be randomly assigned into 2 groups of 50 subjects. A person from research team not involved in the recruitment and assigning participants will generate numbers of envelops using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: One hundred women aged 20 to 50 years old with breast fibrocystic
Interventions: Intervention group will receive Flaxseed oil pearl (contain 350 mg alpha linoleic acid) twice a day and control group will receive vitamin E pearl 200 IU twice a day for two month. Main outcome measures: Duration and severity of breast pain will be evaluated by Cardiff chart and VAS before, first and second month after the intervention. Secondary outcomes include nodularity that will be respectively assessed by Lucknow-Cardiff scale before, first and second month after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612243014N18
Registration date:2017-10-15, 1396/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-04-22, 1396/02/02
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effect of Flaxseed oil and vitamin E on severity of breast pain and nodularity in women with breast fibrocystic: A randomized double blind clinical trial
Public title
The comparison of effect of Flaxseed oil and vitamin E on severity of breast pain and nodularity in women with breast fibrocystic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 20-50 years; willingness to participate in study; existence of lump or pain in breast examination; no willingness for pregnancy; having no malignancy
Exclusion criteria: sensitivity to Flaxseed oil; not willing to continue the study; breast- feeding women
Age
From 75 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Payambar azam university complex, 18 km Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Postal code
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
IR.Mazums.Rec.96.2971
Health conditions studied
1
Description of health condition studied
Fibrosclerosis of breast
ICD-10 code
N60.3
ICD-10 code description
Cystic mastopathy with epithelial proliferation
Primary outcomes
1
Description
Breast pain severity
Timepoint
One month before intervention, first month after intervention, second month after intervention
Method of measurement
Cardiff chart, VAS
Secondary outcomes
1
Description
Breast nodularity
Timepoint
One month before, first and second month after intervention
Method of measurement
Lacknow-Cardiff scale
Intervention groups
1
Description
Control group will receive vitamin E pearl 200 IU twice a day for two month.
Category
Placebo
2
Description
Intervention group will receive Flaxseed oil pearl (contain 350 mg alpha linoleic acid) twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahriar clinic
Full name of responsible person
Street address
Qaran street, Sari, Mazandaran, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Ahmadali Enayatifard
Street address
Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Shahram Ala
Position
Professor of clinical pharmacy
Other areas of specialty/work
Street address
Payambare azam university complex, 18 km Khazarabad road, Sari, Mazandaran, Iran
City
Sari
Postal code
iran
Phone
+98 111142265843
Fax
Email
sh204ala@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Sharam Ala
Position
Clinical pharmacy specialist, Professor
Other areas of specialty/work
Street address
Payambar azam university complex,18 km Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 11 3354 3084
Fax
Email
sh204ala@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Shahram Ala
Position
Professor of clinical pharmacy
Other areas of specialty/work
Street address
Payambar azam university complex, 18 km Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
+98 11 4226 5843
Fax
Email
sh204ala@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)