This study is a clinical trial to evaluate effect of Nigella Sativa Oill and Vitex agnus on severity mastalgia during pregnancy with two intervention groups and a placebo group . This study is a triple blind. Samples of human society consists of women 15 to 49 years with cyclic mastalgia who is referred to the Breast Cancer Research. Breast pain before the intervention, after the intervention, using a ruler pain (visual pain scale) and McGill questionnaire will be evaluated. Women with inclusion criteria were randomized to an intervention groups and a control group. An intervention group , 10 ml (two tablespoons) of syrup containing 5 mL of Nigella Sativa Oil mixed with honey and water will use daily. Another experimental group, 10 ml (two tablespoons) mixed with water and honey syrup containing 60 drops Vitagnus will use daily. The placebo group, 10 ml (two tablespoons) of syrup containing 1 ml of edible oil mixed with water and honey para Finn will be given for 3 months.The placebo group, 10 ml (two tablespoons) of syrup containing 1 ml of Minral Oil mixed with water and honey will be given for 3 months (Daily per person in each group will receive two ml honey daily). Form completed by the participants will be recorded daily pain every day. pain scores after the intervention will compare to pain scores before the intervention. Improvement in pain intensity than before the intervention and the outcome will be the case.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104304785N3
Registration date:2015-02-02, 1393/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Seyedeh Tahereh Mirmolaei
Name of organization / entity
Nursing and Midwifery Faculty - Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982166927171- 00982166937120
Email address
mirmolaei@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sicences
Expected recruitment start date
2014-08-09, 1393/05/18
Expected recruitment end date
2015-03-09, 1393/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nigella sativa oill and Vitex agnus on severity mastalgia during pregnancy
Public title
Comparison of Nigella sativa oill and Vitex agnus on breast pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women who have literacy; women who are between 49-15 years; women who have cyclic mastalgia; women have not with suspicious lesions or ulcers on ultrasound or mammography over the last year; visual pain scale score (vas) is more than3; women have not with a history of breast surgery; women experience physical and mental illness are not known; women who not use of any medication such as analgesics, anti-inflammatory drugs and other treatments for mastalgia during the last two months; women who do not Addiction to drugs; women who do not consume alcohol; women who do not smoke.
Exclusion Criteria: women with mastalgia who are allergic to medications; women with mastalgia who are not willing to continue to work and are not taking drug; women do not have medication during every month for more than 2 days and 4 days of intermittent; women who become pregnant during the study; Women who need to take painkillers regularly.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Siences
Street address
6th floor, Central Building, Ghods Street, Keshavarz Street.
City
Tehran
Postal code
Approval date
2014-06-14, 1393/03/24
Ethics committee reference number
93-01-28-25215-111782
Health conditions studied
1
Description of health condition studied
Communication of Nigella sativa oill and Vitex agnus on severity mastalgia durig the female reproductive.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity mastalgia
Timepoint
2 months before the intervention, and 3 months after intervention
Method of measurement
Visual analog pain scale and McGill questionnaire
Secondary outcomes
1
Description
Black Seed Oil impact of the intervention group
Timepoint
3 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Black Seed is one of the intervention groups
Category
Treatment - Drugs
2
Description
The second intervention group is taking Vitex agnus.
Category
Treatment - Drugs
3
Description
The third group is the Placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Cancer Research
Full name of responsible person
Seiede Tahereh Mirmolaei
Street address
Tehran University of Medical Sciences, Faculty of Nursing and Midwifery, Nusrat Street, Tohid Square, Tehran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Deputy of chanceller for research
Street address
Deputy of chanceller for reseach, 6th floor, Central Building, Ghods Street, Keshavarz Street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Siences
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
Tehran University of Medical Sciences
Full name of responsible person
Ameneh Sotoodeh Moridani
Position
M.S. Midwifery student
Other areas of specialty/work
Street address
Unit 6, Damascus dormitory, Damascus Street, Tehran.
City
Tehran
Postal code
Phone
+98 21 8892 3198
Fax
Email
Amanehsotodeh9@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Seyedeh Tahereh Mirmolaei
Position
Member faculty of Tehran University, master degre midwifery
Other areas of specialty/work
Street address
Tohid square, Nosrat street, faculty of nursing and midwifery.
City
Tehran
Postal code
Phone
+98 912 224 5100
Fax
Email
mirmolaei@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of nursing and midwifery, Tehran Medical Scienc University
Full name of responsible person
Ameneh Sotoodeh Moridani
Position
Master degree midwifery
Other areas of specialty/work
Street address
Unit 6, Damascus dormitory, Damascus Street, Vali Asr Square.
City
Tehran
Postal code
Phone
+218 8923198
Fax
Email
amanehsotodeh9@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)