(1) Objective: Comparison of the effects of Evening Primrose and Vitamin B6 on the severity of mastalgia associated with fibrocystic breast changes.
(2) Study design: The sampling will be random and triple blind.
This study will be placebo-controlled and single center.
The study population : All Iranian women with fibrocystic changes in breast
Sample size: 96
(3) In this semi-experimental study will participate 96 subjects with mastalgia associated with fibrocystic changes.
(4) Inclusion criteria : Iranian women aged 18 to 50 years before menopause; non-pregnant women; non-lactating women; women with mastalgi; rejection of cancer and other breast diseases based on clinical and laboratory evidence by specialist in surgery and breast diseases; not taking medications to reduce pain (eg Danazol, Tamoxifen, Bromocriptine) during the past three months. Exclusion criteria: Pregnancies; physical or mental illness during intervention; taking any herbal or chemical or hormonal drugs during the study; unwillingness to continue taking the medication as directed; No medicine use more than 5 days
(5) Intervention: They are divided into three groups. Group 1: Evening primrose 2 capsules 1000 mg daily, group 2: Vitamin B6 2 capsules 50 mg daily, group 3: placebo 2 capsules daily, for three months
(6) Primary outcome measure): severe of mastalgia
General information
Acronym
FCC - EPO
IRCT registration information
IRCT registration number:IRCT2016062128574N1
Registration date:2016-07-02, 1395/04/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Rojin Tolouei
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
toloei.r@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Evening Primrose and Vitamin B6 on the severity of mastalgia associated with fibrocystic breast changes.
Public title
Comparison of the effects of Evening Primrose and Vitamin B6 on the severity of mastalgia associated with fibrocystic breast changes.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Iranian women aged 18 to 50 years before menopause; non-pregnant women; non-lactating women; women with mastalgi; rejection of cancer and other breast diseases based on clinical and laboratory evidence by specialist in surgery and breast diseases; not taking medications to reduce pain (eg Danazol, Tamoxifen, Bromocriptine) during the past three months. Exclusion criteria: pregnancies; physical or mental illness during intervention; taking any herbal or chemical or hormonal drugs during the study; unwillingness to continue taking the medication as directed; no medicine use more than 5 days
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Sample allocation in the case and control group will be conducted randomly and using lottery through numbering 1, 2 and 3 on the cards. The samples will be asked to pick a card. By choosing a card, randomly the sample will be placed in one of the following groups: Group Evening Primrose (2 capsules 1000 mg daily), Vitamin B6 (2 capsules 50 mg daily) and placebo groups (2 capsules daily)
Blinding:the medicine (Evening Primrose and Vitamin B-6) and placebo in the form of similar capsules will be produced by pharmacology advisor. Also putting capsules in the same containers and coding them will be performed by him. And at the end of the study and after analyzing the results, the capsule containers will be decoded. Thus, the samples are not aware of the contents of the medicine containers. As well as researchers and statistical analysts are not aware of the contents of the medicine containers and each groups What medications are taking. So, the study is a triple-blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
City
Tehran
Postal code
1996713883
Approval date
2016-06-12, 1395/03/23
Ethics committee reference number
IR. IUMS. REC 1395 - 9311373020
Health conditions studied
1
Description of health condition studied
Fibrocystic changes of breast
ICD-10 code
N60
ICD-10 code description
Benign mammary dysplasia
Primary outcomes
1
Description
The severity of mastalgia
Timepoint
Before the intervention, one month and two months and three months after intervention
Method of measurement
Visual analog scale questionnaires
Secondary outcomes
1
Description
Number of days with pain
Timepoint
Before the intervention, one month and two months and three months after intervention
Method of measurement
Daily record pain questionnaire
Intervention groups
1
Description
Intervention group: Evening Primrose group 2 capsules 1000 mg daily for 3 months, the Vitamins B 6 group, 2 capsules 50 mg daily for 3 months,
Evening Primrose is made Barij, Vitamin B6 capsules made Shahid Beheshti University of Medical Science in the School of Pharmacy
Category
Placebo
2
Description
Control group: placebo 2 capsules daily for 3 months
Placebo capsules, made School of Pharmacy Shahid, Beheshti University of Medical Sciences
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Clinic of Milad hospital
Full name of responsible person
Doktor Maria Hashemian
Street address
Breast Clinic, Milad Hospital, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Morteza Naser Bakhat
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
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, Iran 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
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Rojin Tolouei
Position
Master student of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
tolouei.roj@gmail.com; toloei.r@tak.iums.ac.ir
Web page address
www.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Medical Sciences Iran, School of Nursing and Midwifery
Full name of responsible person
Fereshteh Jahdi
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Yasemi Rashid Street, Valiasr Street, Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
jahdi_fr@yahoo.com
Web page address
www.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciences Iran, School of Nursing and Midwifery
Full name of responsible person
Rojin Tolouei
Position
Master Student Of Midwifery
Other areas of specialty/work
Street address
Rastvan Street, Pasdaran Street, Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 21 8820 1978
Email
tolouei.roj@gmail.com; toloei.r@tak.iums.ac.ir
Web page address
www.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)