Cyclic mastalgia is a common condition in women seen in primary care practices. The clinical presentation is often described as premenstrual breast pain and tenderness at least five days and resolution of symptoms with menstruation. Nearly 70-80 percent of premenopausal women are affected by breast pain at some point in their life. The aim of this study is to evaluate the effectiveness of vitamin B6 and E for pain control in women with cyclic mastalgia. This double blind clinical trial will carry out in eighty women with premenstrual cyclic mastalgia in referents to medical and health centers in Hamadam city, Iran. Witten informed consent will obtain from all participants. The participants will randomly select to one of two months oral treatments groups: Vitamin E (200mg/day) or Vitamin B6 (40 mg/day). The severity of breast pain will measure by the visual analogue scale (VAS) and McGill pain questionnaire at enrollment and end of two months. Data will analyze by SPSS/16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106266888N1
Registration date:2011-07-23, 1390/05/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-23, 1390/05/01
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan Univercity of Medical Sciences
Expected recruitment start date
2011-07-01, 1390/04/10
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Study of Therapeutic effect of Vitamin B6 or E on Cyclic Mastalgia
Public title
Therapeutic effect of Vitamin B6 or E on Cyclic Mastalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female; Age between 15-45; Not pregnant; Not breastfeeding; Lack of alleregy to drugs, Exclusion criteria: Women with age below 15 and above 45 years; Pregnancy; Lactation; Alleregy to drugs; Use of drugs (Hormonal;Danazol; Aspirin;Bromocriptine)
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
518/65178
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
d/p/16/35/9/784
Health conditions studied
1
Description of health condition studied
Cyclic Mastalgia
ICD-10 code
N64.4
ICD-10 code description
Cyclical breast pain can range intensity during menstruation
Primary outcomes
1
Description
cyclic mastalgia
Timepoint
Monthly
Method of measurement
According to Visual Analog Scale and Cradiff Breast Pain Chart
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
Monthly
Method of measurement
According to person
Intervention groups
1
Description
Vitamin E, Oral tablet 200 mg, Dailiy along two months
Category
Treatment - Drugs
2
Description
Vitamin B6, Oral tablet 40 mg, Dailiy along two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Medical and Health Center
Full name of responsible person
Nahid Mohammadi, M.Sc. of Health, Instructor
Street address
No. 11, Takgti Street, Shohada Medical and Health Center
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical Sciences, Department of Research and Technology
Full name of responsible person
Fatemeh Asghari
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences, Department of Research and Technology
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
Hamadan University of Medical sciences
Full name of responsible person
Gita Sangestani
Position
Instructor, M.Sc. of Midwifery
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences, Hamadan
City
Hamadan
Postal code
65178/518
Phone
+98 81 1827 6051
Fax
+98 81 1827 6052
Email
gsangestani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Associated professor, Ph.D. of Maternal and child Health
Other areas of specialty/work
Street address
Fahmodeh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178/518
Phone
+98 81 1827 6051
Fax
+98 81 1827 6052
Email
shobeiri@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Associated Professor/ Ph.D. of Maternal and Health Child
Other areas of specialty/work
Street address
Fahmideh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178/518
Phone
+98 81 1527 6051
Fax
+98 81 1527 6052
Email
shobeiri@umsh.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)