Objectives: This study aims to determine the effect of Vitex agnus-castus and Flaxseed on cyclical mastalgia.
Design: Triple blind Randomized Controlled Trial.
Setting and conduct: This study will be conducted in Tabriz health centers. Eligible women will be selected with convenience sampling and will be randomly assigned into 3 groups of 53 subjects with block sizes of 3 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: 159 women aged 18 to 45 years old with cyclical breast pain.
Interventions: One intervention group will receive Vitex agnus tablet (contain 3.2- 4.8 mg dry extract of vitex fruit, equal 0.42-0.58 mg Aucubin) twice a day plus flaxseed placebo and the other intervention group will receive flaxseed powder 25 grams in a cup of water per day plus Vitex agnus placebo for two menstrual cycles. The control group will receive placebo of flaxseed and Vitex agnus.
Main outcome measures: Duration and severity of breast pain will be evaluated by Cardiff chart before, 1 and 2 months after the intervention.
Secondary outcomes include perimenstrual symptoms, menstrual bleeding that will be respectively assessed by the Shortened premenstrual assessment form and Higham chart before, 1 and 2 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070710324N14
Registration date:2013-12-09, 1392/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-09, 1392/09/18
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitex agnus-castus and Flaxseed on duration and severity of breast pain in women with cyclical mastalgia: A randomised controlled trial
Public title
The effect of Vitex agnus-castus and Flaxseed on duration and severity of breast pain in women with cyclical mastalgia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Complaint of cyclical breast pain and tenderness; aged 18 to 45 years; Not currently taking hormonal contraception; having regular menstrual cycles (cycles 22 to 35 days) in the last 6 months; having a phone number for following; willingness to participate in study and having informed consent; being literate; cyclical breast pain and pain severity score above 7 according to chart Cardiff.
Exclusion criteria: History of breast cancer; History of injury or wound in breast; using of medications that affect on breast pain (anti-depressants, digoxin, methyldopa, spironolactone, Chlorpropamide, danazol and tamoxifen); existence of lump or abnormalities in breast examination; existence of non cyclical breast pain or pain originates outside of the breast; history of asthma or allergies; taking dopamin agonist and antagonist (Levodopa, Amphetamine, Amphetamine, pergolide, Cabergoline, metoclopramide) in the last 6 months; history of breast cancer and other cancers in first-degree relatives; existence of known uterine myoma.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
66156-15733
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
9297
Health conditions studied
1
Description of health condition studied
Cyclical breast pain
ICD-10 code
N60-N64
ICD-10 code description
Disorders of breast
Primary outcomes
1
Description
Duration and severity of breast pain
Timepoint
Before intervention, 1 and 2 months after intervention
Method of measurement
Cardiff chart
Secondary outcomes
1
Description
Menstrual bleeding
Timepoint
Before intervention, 1 and 2 months afterintervention.
Method of measurement
Higham chart
2
Description
Perimenstrual symptoms
Timepoint
Before intervention, 1 and 2 months after intervention
Method of measurement
Shortened premenstrual assessment form
Intervention groups
1
Description
The control group will receive 25 gr placebo of flaxseed daily and placebo tablet of vitex agnus twice a day for two menstrual cycles.
Category
Placebo
2
Description
The first intervention group will recieve tablet of vitex agnus made by Goldaru pharmaceutical company in Esfahan (contain 3.2- 4.8 mg dry extract of vitex fruit, equal 0.42-0.58 mg Aucubin) twice a day plus placebo of flaxseed daily for two menstrual cycles.
Category
Treatment - Drugs
3
Description
The second intervention group will recieve 25 grams of flaxseed powder in a cup of water daily plus placebo tablet of vitex agnus twice a day for two menstrual cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz health centers
Full name of responsible person
Ahmadpur Parivash
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Shakouri Seyyed Kazem
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Ahmadpur Parivash
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
66156-15733
Phone
+98 42 6333 0715
Fax
-
Email
p.ahmadpor_68@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of reproductive health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
347-51745
Phone
+98 41 1479 6770
Fax
-
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)