The effect of an aerobic training course with and without cumin supplementation on serum β-endorphin levels and pain intensity in non-athlete girls with primary dysmenorrhea
Enquiry into changes in serum β-endorphin levels and pain intensity in primary dysmenorrhea following aerobic training with or without cumin supplementation in non-athlete girls
Design
A total of 26 female students who were eligible according to inclusion criteria were selected by convenience sampling method and were assigned into the intervention or control groups via simple allocation method.
Settings and conduct
Participants were incorporated from students residing in student dormitories at Birjand State University. The study is single-blinded such that the participants were unaware of what capsules they consumed and into which group they were assigned. At the start of menstruation, the intervention group consumed cumin capsules on the first 3 days (300 milligrams every 8 hours), while the controls received placebo capsules (with the same dosage). On the third day, beta-endorphin serum levels were measured for all participants. Subsequently, the groups stopped consuming capsules and both took aerobic training from the 4th day of menstruation for 4 weeks. At the onset of the next menstruation, the exercise training stopped and serum levels of beta-endorphin were measured on the third day.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: female students; moderate to severe primary dysmenorrhea.
Main exclusion criterion: consumption of hormonal or analgesic medications before menstruation.
Intervention groups
Intervention Group (Cumin): At the start of menstruation, the intervention group members consumed cumin capsules (300 milligrams every 8 hours) on the first 3 days. On the third day, their beta-endorphin levels were measured. Subsequently, they stopped consuming capsules and took aerobic training from the 4th day of menstruation for 4 weeks. At the onset of the next menstruation, the exercise training stopped. Beta-endorphin levels were again measured on the third day. Control Group (Placebo): At the start of menstruation, the control group members consumed placebo capsules (300 milligrams every 8 hours) on the first 3 days. On the third day, their beta-endorphin levels were measured. Subsequently, they stopped consuming capsules and took aerobic training from the 4th day of menstruation for 4 weeks. At the onset of the next menstruation, the exercise training stopped. Beta-endorphin levels were again measured on the third day.
Main outcome variables
Serum levels of beta-endorphin;
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N41
Registration date:2018-03-23, 1397/01/03
Registration timing:retrospective
Last update:2018-03-23, 1397/01/03
Update count:0
Registration date
2018-03-23, 1397/01/03
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-07-22, 1396/04/31
Actual recruitment start date
2017-06-10, 1396/03/20
Actual recruitment end date
2017-07-11, 1396/04/20
Trial completion date
empty
Scientific title
The effect of an aerobic training course with and without cumin supplementation on serum β-endorphin levels and pain intensity in non-athlete girls with primary dysmenorrhea
Public title
Effects of aerobic training with cumin supplementation on serum β-endorphin levels and pain intensity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 to 25 years
Moderate to severe dysmenorrhea (pain intensity score from 4 to 10)
Single girl
Non-athlete
Regular monthly cycles of more than 21 days and less than 35 days
Pain during menstruation
Exclusion criteria:
Consumption of hormonal medications and any type of herbal or chemical tranquilizers affecting menstrual bleeding since 48 hours before menstruation to the end of the research project
Cardiovascular, hepatic and renal disease
Genital tract infection
Pelvic damage
Secondary dysmenorrhea
Age
From 18 years old to 25 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were assigned into study groups via simple allocation method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single-blinded such that the participants were unaware of what capsules they consumed and into which group they were assigned.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2017-06-07, 1396/03/17
Ethics committee reference number
Ir.Bums.REC.1396.67
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Serum levels of beta-endorphin
Timepoint
on the third days of the first and next menstruation cycles
Method of measurement
ELISA kit (EASTBIOPHARM Company)
2
Description
Pain intensity
Timepoint
on the third days of the first and next menstruations
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Cumin): cumin capsules (300 milligrams every 8 hours) on the first 3 days plus 28 days of aerobic exercise from the fourth day
Category
Treatment - Other
2
Description
Control group (placebo): starch capsules (300 milligrams every 8 hours) on the first 3 days plus 28 days of aerobic exercise from the fourth day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Girl dormitories of Birjand State University
Full name of responsible person
Mohadeseh Eidy Kakhky
Street address
Shokatabad Ave.
City
Birjand
Province
South Khorasan
Postal code
615/97175
Phone
+98 56 3220 2021
Email
M.eidykakhky1993@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 3200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mohadese Eidy Kakhky
Position
Master student in training in Sport Physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Email
M.eidykakhky1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Nahid Ghanbarzadeh
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Email
nghanbarzade@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 32395680
Email
hadirooz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The research team intends to report the findings; however, we do not have a plan to share the raw data.
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
No - There is not 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
Not applicable
Title and more details about the data/document
Study Protocol
When the data will become available and for how long
The protocol will be detailed in a paper that is being published. The paper will be available on the journal's website.
To whom data/document is available
To all researchers
Under which criteria data/document could be used
No certain criterion
From where data/document is obtainable
the journal's website
What processes are involved for a request to access data/document