. "Determination of the effect of Curcumin capsule (turmeric) on the severity and duration of Dysmenorrhea in students
Design
Clinical trials with control group, individually, with parallel groups, double blind, randomized
Settings and conduct
Sampling was done at the university. The two groups received two capsules after two meals for the first two days of the menstrual cycle, which before and three hours after taking the drug each day, the duration of the pain was checked The pain registration and pain regimen were also recorded using the Pain Questionnaire. Finally, the severity and duration of symptoms of Dysmenorrhea were compared before and one and two months after the intervention with the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Regular menstruation (duration of 3 to 8 days with an interval of 21 to 35 days)
11 to 17 years as the age of the onset of the menstrual period
Age of subjects: 18 to 25 years old
Marital status: Single
Nationality: Iranian
Having primary dysmenorrhea
Exclusion criteria:Having background of underlying disease is the secondary Dysmenorrhea , such as endometriosis
Occurrence of known physically diagnosed chronic disease, anatomical mental disorders
Use of any form and type of medical interventions (painkillers)
Taking oral contraceptives
Taking hormonal medications
Intervention groups
The intervention group took curcumin capsules each containing 500 mg turmeric extracts twice a day in the first 3 days of menstruation for 2 months. The control group was treated with the same course and duration; instead, they took placebo for two whole menstruation cycles.
Main outcome variables
The intensity and duration of pain
Before and one and two months after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171031037146N1
Registration date:2018-06-05, 1397/03/15
Registration timing:retrospective
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9431
Email address
shahbaztabari.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
2017-11-05, 1396/08/14
Actual recruitment end date
2018-01-27, 1396/11/07
Trial completion date
empty
Scientific title
. "Investigation of the effect of Curcumin capsule (turmeric) on the severity and duration of Dysmenorrhea in students
Public title
. "Investigation of the effects of Turmeric capsule on decreasing the severity and duration of menstrual pain in students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Regular menstruation (duration of 3 to 8 days with an interval of 21 to 35 days)
Age of subjects: 18 to 25 years old
11 to 17 years as the age of the onset of the menstrual period
Marital status: Single
Nationality: Iranian
Having primary Dysmenorrhea
Exclusion criteria:
Having background of underlying disease causing secondary to Dysmenorrhea, such as endometriosis
Occurrence of known physically diagnosed chronic disease, anatomical mental disorders
Use of any form and type of medical interventions (painkillers)
Taking oral contraceptives
Taking hormonal medications
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
74
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In order to sample at the university and through the call to the students, qualified people (having dual-grade Dysmenorrhea of grade two and three according to the multidimensional speech-scoring criteria questionnaire) who will declare their consent and fill in the consent form in the random blocks Two (intervention and control groups) were randomly assigned to the site www.Sealedenvelope.com. The block sequence structure was arranged in the form of an Excel file. Both individuals were assigned successively to a block in which the order of the groups was caught.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind clinical trial research; the researcher and intervention are unaware
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No. 72,, Tavakol Ave.,Third Square of Tehranpars
City
Tehran
Province
Tehran
Postal code
1656848718
Approval date
2017-09-18, 1396/06/27
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411373008
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary Dysmenorrhea
Primary outcomes
1
Description
The intensity of dysmenorrhea
Timepoint
Before and one and two months after the intervention, before and three hours after taking the medication
Method of measurement
Visual Analouge Scale
Secondary outcomes
1
Description
The duration of pain of Dysmenorrhea
Timepoint
Before and one and two months after the intervention,Before and three hours after taking the drug
Method of measurement
Intervention group: 500 mg Curcumin capsule, the first three days of menstruation for two cycles, twice doses a day
Intervention groups
1
Description
Intervention group: Intervention group: 500 mg Curcumin capsule, the first three days of menstruation for two cycles, one day two
Category
Treatment - Drugs
2
Description
Control group: A placebo capsule containing corn starch weighing about 10 grams carbohydrates (one serving of bread), twice a day for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Naghmeh Shahbaztabari
Street address
Hemat Road.,Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1656848718
Phone
+98 21 7770 0103
Email
naghmehshahbaztabari@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
کاظم ملکوتی
Street address
Hemat Road.,Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 4365 1000
Email
naghmehshahbaztabari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Naghmeh Shahbaztabari
Position
Master of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 72, Tavakol Ave., Falake Sevom Tehranpars
City
Tehran
Province
Tehran
Postal code
1656848718
Phone
+98 21 7770 0103
Email
naghmehshahbaztabari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naghmeh Shahbaztabari
Position
Master of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
no. 72, Tavakol Ave., Falake Sevom Square
City
Tehran
Province
Tehran
Postal code
1656848718
Phone
+98 21 7770 0103
Email
naghmehshahbaztabari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
naghmeh Shahbaztabari
Position
Master of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.72,Tavakol Ave., Falake Sevom Tehranpars
City
Tehran
Province
Tehran
Postal code
1656848718
Phone
+98 21 7770 0103
Email
naghmehshahbaztabari@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