Comparative of the Effectiveness of Turmeric Extract with Mefenamic Acid on Pain Intensity of Primary Dysmenorrhea
Design
A double-blind with parallel groups and randomized clinical trial is conducted
Settings and conduct
Clinical trial is conducted on the female students of Neyshabour dormitories.The medicine will be coded as A and B by the pharmacist and the codes will be randomly selected by the samples themselves.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being single, Aged between 18-28, At least one semester has been left, Having dysmenorrhea with the features of primary dysmenorrhea in most menstrual cycles in the last 6 months, Not participating in other studies
Exclusion criteria: lack of interest in continuing the participation during the study for any reason, Getting married during the study, any Unmodified side effects
Intervention groups
Every participant will be randomly given 27 Mefenamic acid capsules or 27 turmeric capsules for three consecutive cycles. After explaining how each drug is taken, (i.e. three capsules should be taken in the duration of 8 hours from the first day of menstrual period for three days), they will be asked to complete the forms after taking the drug. The medicine will be coded as A and B by the pharmacist and the codes will be randomly selected by the samples themselves. At the end of the study, the cases of study in the two groups receiving turmeric and Mefenamic acid will be evaluated for the pain intensity and possible side effects.
Main outcome variables
pain intensity and possible side effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160821029446N5
Registration date:2018-06-20, 1397/03/30
Registration timing:prospective
Last update:2018-06-20, 1397/03/30
Update count:0
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of the Effectiveness of Turmeric Extract with Mefenamic Acid on Pain Intensity of Primary Dysmenorrhea
Public title
Comparative of the Effectiveness of Turmeric Extract with Mefenamic Acid on Pain Intensity of Primary Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being single
Aged between 18-28
At least one semester has been left
Having dysmenorrhea with the features of primary dysmenorrhea in most menstrual cycles in the last 6 months
Having regular menstrual cycle (21-35 days)
Not having female genital problems (ovarian cysts, fibroma, abnormal uterine bleeding)
Absence of coagulation disorders
Absence of abdominal and pelvic surgery history
Absence of drug interaction such as glycemic control drugs and high blood pressure drugs
Absence of allergy to turmeric and its compounds
Absence of allergy to non-steroidal anti-inflammatory drugs
Not using relaxation techniques over the last 6 months
Absence of physical and mental illness
Not participating in other studies
Exclusion criteria:
Unwillingness to continue the participation during the study for any reason
Getting married during the study
any Unmodified side effects
Age
From 18 years old to 28 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will be stratified quota sampling in which each dormitory will be considered as a stratify. After selecting the samples from the first dormitory, they were randomly divided into two groups receiving Mefenamic acid capsules and turmeric extract capsules. The samples were selected randomly in the second dormitory like those of the first one.
Blinding (investigator's opinion)
Double blinded
Blinding description
A double-blind randomized clinical trial is conducted. The study is blinded by coding the drugs by the pharmacist (A and B), and the pharmacist placed the provided drugs (i.e. mefenamic acid and turmeric extract capsules) in the cans with the same colors and shapes and randomly coded them. Three capsules should be taken for three days in a month during three months and the researcher and participants do not have any idea about which drug is coded as A or B. For each half of the participants in the dormitory, codes are written on the pieces of the paper and then are placed in a bag. At the beginning of the treatment cycle, the participants were asked to take a code from the bag by chance and then they were given a drug according to the selected code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing and Midwifery and Rehabilitation Faculty of Tehran University of Medical
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-04-08, 1397/01/19
Ethics committee reference number
IR.TUMS.FNM.REC.1397.4933
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Dysmenorrhea intensity
Timepoint
In 2 control cycles and then after taking drugs In the form of three capsules every 8 hours for three days until 3 cycles.
Method of measurement
verbal multidimensional scoring system
2
Description
Blood loss during menstrual cycle
Timepoint
In 2 control cycles and then after taking drugs In the form of three capsules every 8 hours for three days until 3 cycles.
Method of measurement
Pictorial Blood Loss Assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Every participant will be randomly given 27 turmeric capsules for three consecutive cycles. After explaining how each drug is taken, (i.e. three capsules should be taken in the duration of 8 hours from the first day of menstrual period for three days), they will be asked to complete the forms after taking the drug.
Category
Treatment - Drugs
2
Description
Control group: Every participant will be randomly given 27 Mefenamic acid capsules for three consecutive cycles. After explaining how each drug is taken, (i.e. three capsules should be taken in the duration of 8 hours from the first day of menstrual period for three days), they will be asked to complete the forms after taking the drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Girl's dormitory of Neyshabour Azad University
Full name of responsible person
Monireh Soghandi
Street address
Monastery Road, Islamic Azad University, Research Center
City
Neyshabour
Province
Razavi Khorasan
Postal code
۹۳۱۹۷۹۷۱۳۹
Phone
+98 51 4262 1910
Email
Neyshabur@iau-neyshabur.ac.ir
2
Recruitment center
Name of recruitment center
Girl's dormitory of Neyshabour Govermental University
Full name of responsible person
Maryam Modiri
Street address
42 central dormitories, The 15th of Khordad Avenue
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319774400
Phone
+98 51 4262 1731
Email
Neyshabur@iau-neyshabur.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
Number 23, Dameshgh Street, Valiasr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4222
Email
maryam_damghanian@yahoo.com
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 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Yazdi
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Iran, Tehran, Tohid Square, Tehran University of Medical Sciences, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2966 1717
Email
yazdimaryam20@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Iran, Tehran, Tohid Square, Tehran University of Medical Sciences, Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733172
Phone
+98 21 6692 7171
Email
Maryam_damghanian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, East Nosrat Ave, Towhid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 5016 2224
Email
maryam_damghanian@yahoo.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