Comparative study of Nigella sativa Seeds Capsules and vitamin B6 on the severity of premenstrual syndrome symptoms in students
Design
The clinical trial had 3 control, intervention, and placebo groups with parallel groups, randomized on 105 patients, and a randomization block design with size 6 was used for randomization (using the computer program Createa blocked randomization list with the link https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Settings and conduct
This triple-blind randomized clinical trial study will be conducted on 105 students with premenstrual syndrome living in the dormitories of Rafsanjan University of Medical Sciences in 2024.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1) Being single
2) Willingness to participate in the study
3) Completing a written informed consent form
4) Age 18 to 35 years
5) Having regular menstruation of 21 to 35 days
6) Bleeding duration of 3 to 10 days
7) Obtaining a score of 33-64 from the Premenstrual Syndrome Assessment Questionnaire
Exclusion criteria
8) Having a specific underlying disease (diabetes, blood pressure, thyroid instability) and diseases of the reproductive system
9) Taking medications that affect premenstrual syndrome, antidepressants, birth control pills and hormones
10) The occurrence of stressful events such as the death of a loved one within the past year
11) Smoking
12) The occurrence of complications or drug allergies
13) Regular exercise
Intervention groups
Intervention: black seed consumption, control: vitamin B6 consumption, placebo: no drug consumption
Main outcome variables
Reducing symptoms of the syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240614062131N1
Registration date:2025-03-21, 1404/01/01
Registration timing:registered_while_recruiting
Last update:2025-03-21, 1404/01/01
Update count:0
Registration date
2025-03-21, 1404/01/01
Registrant information
Name
Elham kabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3377 2356
Email address
elhamkabi56@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-29, 1403/10/09
Expected recruitment end date
2025-05-30, 1404/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of black seed capsules and vitamin B6 on the severity of premenstrual syndrome symptoms in students
Public title
Comparative study of the effect of black seed capsules and vitamin B6 on the severity of premenstrual syndrome symptoms in students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being single
Willingness to participate in the study
Completed a written informed consent form
Age 18 to 35 years
Having a regular menstrual cycle of 21 to 35 days
Bleeding duration of 3 to 10 days
Obtaining a score of 33-64 on the Premenstrual Syndrome Assessment Questionnaire
Exclusion criteria:
Unwillingness to participate in the study
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:
105
Randomization (investigator's opinion)
Randomized
Randomization description
They were divided into 3 groups of 35 people (vitamin B6 capsules, black seed capsules, and placebo) in a random block design with a size of 6 (using the computer program Createa blocked randomization list with the link https://www.sealedenvelope.com/simple-randomiser/v1/lists).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Central Organization- Imam Ali (AS) Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2024-12-02, 1403/09/12
Ethics committee reference number
IR.RUMS.REC.1403.142
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
Premenstrual syndrome score from the questionnaire
Timepoint
At the beginning of the study (before the intervention) and one month and two months after the end of the intervention
Method of measurement
Premenstrual Syndrome Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Black seed oil capsules 500 mg, 2 per day, in two menstrual cycles, from 3 days before menstruation to 1 day after menstruation, Barij Essential Oil Company
Category
Treatment - Drugs
2
Description
Intervention group: 40 mg vitamin B6 capsules, 2 per day, in two menstrual cycles, from 3 days before menstruation to 1 day after menstruation, Galenus Company
Category
Treatment - Drugs
3
Description
Control group: Placebo, 500 mg starch capsules, 2 per day, from 3 days before menstruation to 1 day after menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Student dormitories of Rafsanjan University of Medical Sciences
Full name of responsible person
Marzieh Najjar
Street address
Central Organization-Imam Ali (AS) Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
Email
m_najar@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Central Organization-Imam Ali (AS) Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
rvazirinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzieh Najar
Position
academic board
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Central Organization-Imam Ali (AS) Boulevard
City
rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
m_najar@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Marzieh Najar
Position
academic board
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Central Organization-Imam Ali (AS) Boulevard
City
rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
m_najar@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Elham Kabi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Khashayar St
City
Ahvaz
Province
Khouzestan
Postal code
7717933777
Phone
+98 61 3377 2356
Fax
Email
elhamkabi56@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Article
When the data will become available and for how long
Print article 1404
To whom data/document is available
All people
Under which criteria data/document could be used
Other articles
From where data/document is obtainable
Journal site
What processes are involved for a request to access data/document