Comparative study of the effect ofcapsules "ginger-lavender" ,”ginger”with “mefenamic “acid on the severity of primary dysmenorrhea pain in female students living in selected dormitories of Shahid Beheshti University of Medical Science-1399
Design
Controlled clinical trial work, with parallel groups, triple-blind, randomized, phase 3 on 90 students, Excel software is used for randomization
Settings and conduct
After selecting three dormitories(Zeynab, Alzahra and Somayeh) from Shahid Beheshti University of Medical Sciences, sampling will be done continuously and purposefully. The method of coding on cans is used for blinding.Researcher, samples and statistics consultants are blind
Participants/Inclusion and exclusion criteria
Be 1)18 to 30 years old and single.
2) Experience menstrual pain in the first 3 days of bleeding for 3 consecutive periods in the last 6 months.
3) People with primary dysmenorrhea whose pain intensity is moderate to severe according to McGill's pain ruler.
The exit criteria in this study include:
1) Dissatisfaction or obedience of the person to continue participating in the study
2) Lack of proper use of medication or mefenamic acid
3) Taking any herbal medicine while studying
Intervention groups
Pain intensity is recorded in three groups based on the pain ruler, before the intervention (as a base) and in the first and second cycles after the intervention.Consumption of 500 mg of "ginger-lavender" , 250 mg capsules of "ginger" and 250 mg of" Mefenamic acid".During the two periods, with the help of a questionnaire, a system of several verbal dimensions and (visual analog scale) are obtained.4 times a day from the onset of pain until three days of menstruation will be use .Average pain at the end of the three days of menstruation will be relieved with the help of visual analog scale.
Main outcome variables
Severity of primary dysmenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200525047565N2
Registration date:2021-01-03, 1399/10/14
Registration timing:retrospective
Last update:2021-01-03, 1399/10/14
Update count:0
Registration date
2021-01-03, 1399/10/14
Registrant information
Name
Sharareh Jannesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
shararehjannesari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-09, 1399/05/19
Expected recruitment end date
2020-11-09, 1399/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of capsules "Ginger-Lavender" ,"Ginger" with "Mefenamic Acid " on the severity of primary dysmenorrhea
Public title
Comparative study of the effect of capsules "Ginger-Lavender", "Ginger" with "Mefenamic Acid " on the severity of primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1)Be 18 to 30 years old and single.
2)Experience menstrual pain in the first 3 days of bleeding for 3 consecutive periods in the last 6 months
3)People with primary dysmenorrhea whose pain intensity is moderate to severe according to McGill's pain ruler
4)Not known to be a person with a chronic illness (diabetes, high blood pressure, cardiovascular, infectious, liver, and epilepsy)
5)Do not have a specific gynecological disease that interferes with the study process
6)Have regular cycles with intervals of 21 to 38 days and the duration of menstruation is 3-7 days
7)Their body mass index is in the normal range of 19.8 to 26
8)According to the person, there are no symptoms such as burning, itching or abnormal discharge during the study.
9)Do not take any medications or supplements.
10)No herbal medicine has been used for 3 months before the intervention.01
11)Stressful factors such as parental separation, death of first-degree relatives, etc. should not be present in the last six months
Exclusion criteria:
1)Dissatisfaction or obedience of the person to continue participating in the study
2)Lack of proper use of medication or mefenamic acid
3)Take any herbal medicine while studying
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, sampling is selected based on the number of targets from the single girl living in the dormitory.After introducing herself, the researcher will explain to the participants the goals and how to implement the research.Then, out of 90 students with study characteristics who have primary dysmenorrhea, they are
placed in separate blocks (moderate and severe dysmenorrhea).In the next stage, people with moderate to severe pain are divided into three equal groups of capsule users"Ginger - Lavender" "Ginger" and" Mefenamic Acid " by accidental assignment using Excel software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The blinding was done in such a way that the capsule containing Ginger-Lavender and capsule containing Ginger was prepared in exactly the same way as the Mefenamic Acid capsule and coded.Only the Pharmacogenesis Consultant is aware of its contents and codes, and the researcher and participants in the research and data analyser are unaware of it.In this way, the study will be done in triple blind ways.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee In Research, School of Farmecy, Nurssing, Midwifery of Shahid Beheshti University.
Street address
Schoole of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Valiasr Street, Intersection of Niayesh Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.239
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Severity of primary dysmenorrhea
Timepoint
End of the third day of the cycle before the intervention, end of the third day of the first cycle and second cycle after the intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Systematic symptoms
Timepoint
End of the third day of the cycle before the intervention, end of the third day of the first cycle and second cycle after the intervention
Method of measurement
Verbal rating scale
Intervention groups
1
Description
Intervention group: "Ginger-Lavender" group500 mg capsules containing 250 mg of ginger and 250 mg of lavender prepared in Shahid Beheshti School of Traditional Medicine will be used 4 times a day (once every 6 hours) from the beginning of menstruation until the third day. Basic pain (before the intervention) is measured with the help of a pain ruler, then during the two intervention periods, the relevant questionnaire (pain ruler) will be given to the sample, and at the end, the average pain at the end of every three days will be estimated.
Category
Treatment - Drugs
2
Description
Intervention group: "Ginger" group will use 250 mg "Ginger" capsule prepared in Shahid Beheshti School of Traditional Medicine 4 times (once every 6 hours) from the beginning of menstruation until the third day. The pain reliever is measured, then during the two intervention periods, the relevant questionnaire (pain reliever) will be given to the sample, and at the end, the average pain at the end of every three days will be estimated.
Category
Treatment - Drugs
3
Description
"Mefenamic Acid" group will use Amin Company's 250 mg "Mefenamic Acid" capsule 4 times a day (every 6 hours) from the beginning of menstruation until the third day. Basic pain (before intervention) is measured with the help of a pain ruler. Then, during the two intervention periods, the relevant questionnaire (pain ruler) will be given to the sample and at the end, the average pain at the end of every three days will be estimated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected Dormitories of Shahid Beheshti University of Medical Sciences.
Full name of responsible person
Tahereh kalate
Street address
Schoole of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Valiasr Street, Intersection of Niayesh Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8842 2022
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Arabi St, Yemen St, next to Ayatollah Taleghani Hospital, Shahid Chamran Highway,Tehran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 29901
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
1
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sharareh Jannesari
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Schoole of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Vali-Asr Avenue, Intersection Vali-Asr and Neiaiesh Highway, Tehran, Iran .
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
shararehjannesari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sharareh Jannesari
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Schoole of Nursing and Midwifery, Valiasr Street, Intersection of Niayesh Highway,Tehran, Iran .
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0218855366
Fax
Email
shararehjannesari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sharareh Jannesari
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Schoole of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Valiasr Street, Intersection of Niayesh Highway, Tehran, Iran .
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0218865366
Email
shararehjannesari@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 data remains confidential to the researcher at first
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This research is to see the effect of ginger-lavender and ginger capsule on the severity of primary dysmenorrhea.
When the data will become available and for how long
After the article is published in the desired journal is available
To whom data/document is available
Everyone who is interested in the article
Under which criteria data/document could be used
To increase women's health and use more herbal medicines
From where data/document is obtainable
Email the corresponding author
What processes are involved for a request to access data/document
Explain the reasons for requesting an article in the email.