1. Objective: Determination and comparison of the severity of physical and behavioral symptoms of Premenstrual syndrome in the intervention and control groups before and after the study at the end of the first and second months. 2. Design: This study was a double-blind clinical trial conducting. 3. Setting and conduct: Research units with Inclusion criteria easy sampling was after completing the list of questionnaire and obtaining informed consent of subjects enrolled in research and they will be asked Calender of Premenstrual Experience at the end of each day and the amount of menstrual cycle (during bleeding days Menstruation) completed the in two cycles of control and then delivered to researcher. Research units are allocated into Nigella sativa seeds and Placebo groups using random numbers table and had given Nigella sativa seeds and Placebo capsules that their nature is identified with the letters A and B will be marked only for pharmacist consultant to be delivered to research units. They use from 7 days befor the start of menstrual bleeding to 3 days menstrual bleeding in first and second cycle intervention and complete the questionnaire and to submit researcher. 4. Participants including major eligibility criteria: Students studying at Mashhad University of Medical Sciences and residing in a dormitory suffering from Premenstrual syndrome with: Inclusion criteria: Aged between 18 and 35; Regular and normal menstruation. Exclusion criteria: Pregnancy and lactation; Any history disorders; Any drug use; Smoking or drinking alcohol; Professional athlete; Depression and Anxiety and extreme stress; Use of traditional medicine methods to reduce the physical and behavioral symptoms of premenstrual syndrome ; BMI ≥30. 5. Intervention: Intervention group: Consumption of Nigella sativa seeds capsules to the 1,500 mg orally daily (3 capsules of 500 mg in 3 doses every 8 hours on a full stomach) from 7 days befor the start of menstrual bleeding to 3 days menstrual bleeding will be given for 2 cycles. Control group: Consumption of Placebo capsules to the 1,500 mg orally daily (3 capsules of 500 mg in 3 doses every 8 hours on a full stomach) from 7 days befor the start of menstrual bleeding to 3 days menstrual bleeding will be given for 2 cycles. 6. Main outcome measures (variables): The Severity of physical and behavioral symptoms of premenstrual syndrome.
General information
Acronym
PMS
IRCT registration information
IRCT registration number:IRCT2017011131881N1
Registration date:2017-07-08, 1396/04/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Samaneh Maskani
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 1276
Email address
maskanis931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-22, 1395/11/03
Expected recruitment end date
2017-06-24, 1396/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of capsules Nigella sativa seeds on the severity of symptoms of Premenstrual syndrome
Public title
The effect of capsules Nigella sativa seeds on the Premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Student studying at Mashhad University of Medical Sciences and residing in a dormitory; Iranian and Muslim; Aged between 18 and 35; Regular & normal menstruation; And having premenstrual syndrome. Exclusion criteria: Pregnancy and lactation; Any history disorders; Any drug use; Smoking or drinking alcohol; Professional athlete; Depression and Anxiety and extreme stress; Use of traditional medicine methods to reduce the physical and behavioral symptoms of premenstrual syndrome ; BMI ≥30.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
University Ave
City
Mashhad
Postal code
Approval date
2017-01-09, 1395/10/20
Ethics committee reference number
IR.MUMS.REC.1395.484
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
The severity of physical symptoms of Premenstrual syndrome
Timepoint
Daiy 2 cycles before the intervention. 2 cycles after the intervention
Method of measurement
Questionnaire COPE
Secondary outcomes
1
Description
The Severity of behavioral symptoms of Premenstrual syndrome
Timepoint
Daiy 2 cycles before the intervention. 2 cycles after the intervention
Method of measurement
Questionnaire COPE
Intervention groups
1
Description
Intervention group: Consumption of Nigella sativa seeds capsules to the 1,500 mg orally daily (3 capsules of 500 mg in 3 doses every 8 hours on a full stomach) from 7 days befor the start of menstrual bleeding to 3 days menstrual bleeding will be given for 2 cycles.
Category
Treatment - Drugs
2
Description
Control group: Consumption of Placebo capsules to the 1,500 mg orally daily (3 capsules of 500 mg in 3 doses every 8 hours on a full stomach) from 7 days befor the start of menstrual bleeding to 3 days menstrual bleeding will be given for 2 cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences dormitories
Full name of responsible person
Samaneh Maskani
Street address
Bahonar avenue, dormitory Pardis
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
University Ave
City
Mashhad
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,Mashhad 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
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Maskani
Position
Master of Midwifery Student
Other areas of specialty/work
Street address
No 8, Eram 13 Alley, Eram Avenue.
City
Sabzevar
Postal code
9618673991
Phone
+98 51 4464 1276
Fax
+98 51 4423 2362
Email
Maskanis931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Lecture, Department of Midwifery, Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mashhad University of Medical Sciences, Ebnecina Avenue
City
Mashhad
Postal code
Phone
+98 51385981511
Fax
Email
Tafazolim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Maskani
Position
Master of Midwifery Student
Other areas of specialty/work
Street address
No 8, Eram 13 Alley, Eram Avenue.
City
Sabzevar
Postal code
9618673991
Phone
+98 51 4464 1276
Fax
+98 51 4423 2362
Email
Maskanis931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)