Comparison of the effects of two different doses of magnesium (150، 300 mg) with placebo on severity of primary dysmenorrhea and amount of menstrual bleeding in female students (18-34 years old)
The aim of this randomized controlled trial is to compare effectiveness of two different doses of magnesium on severity of primary dysmenorrhea and amount of Menstrual Bleeding. Sixty eligible persons will be selected for the study and will be randomized using blocks with 3 and 6 cells into three groups (one group will be received tablet of magnesium 150mg, the second group will receive magnesium 300mg and the third one will be placebo). The medications and placebo are quite similar that participants should use them from 15th day of menstrual cycle until complete relief of pain during two months. Ibuprofen 400 mg tablets will be given to participants they will requested to use them in case of they need them and record all medications that they receive. The researcher and participants are not aware of nature of medication or placebo and all medications will be prepared by one pharmacist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080319743N2
Registration date:2016-01-22, 1394/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Masumeh Yaralizadeh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
yaralizadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz JundiShapur University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of two different doses of magnesium (150، 300 mg) with placebo on severity of primary dysmenorrhea and amount of menstrual bleeding in female students (18-34 years old)
Public title
Comparison of the effects of two different doses of magnesium with placebo on severity of pain of menstrual and amount of menstrual bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Single students aged 18-34 years residing in dormitory, having primary dysmenorrhea, regular and painful menstruation in previous 1 year with pain score equal or more than 5 according to visual analogue scale. Exclusion criteria: Known serious diseases like epilepsy, severe digestive disorders, cardiovascular, renal diseases, pelvic inflammatory diseases, consumption of oral contraceptive pills in previous 6 months or desire to take them during study and allergy to NSAIDs.
Age
From 18 years old to 34 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sixty participants will be randomized using blocks with 3 and 6 cells into 3 groups, (one group will receive tablet of magnesium 150mg, the second group will receive magnesium 300mg and the third one will receive placebo). This study is a double blind randomized controlled trial therefore the researcher and participants are not aware of nature of medication or placebo tablets will be prepared by one pharmacists.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Ahvaz Jundishapur University of Medical Science
Street address
Ground floor, Department of Research and Information Technology University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Postal code
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
AJUMS.REC.1394.347
Health conditions studied
1
Description of health condition studied
dysmenorreha
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrhea
Primary outcomes
1
Description
Mean severity of menstrual pain
Timepoint
Before and two months after intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Amount of menstrual bleeding
Timepoint
Before and two months after intervention
Method of measurement
Higham Chart
Secondary outcomes
1
Description
Need to take additional pain relief drug for dysmenorrhea
Timepoint
Before and two months after intervention
Method of measurement
Number of analgesics used
Intervention groups
1
Description
Taking Tablets containing 150 mg Magnesium once a day from 15th day of menstrual cycle to complete relief of pain for two months.
Category
Treatment - Drugs
2
Description
Control group: Taking Tablets containing placebo once a day from 15th day of menstrual cycle to complete relief of pain for two months.
Category
Placebo
3
Description
Intervention 2: Taking Tablets containing 300 mg Magnesium once a day from 15th day of menstrual cycle to complete relief of pain for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran University of Ahvaz dormitory
Full name of responsible person
Masumeh Yaralizadeh
Street address
Shahid Chamran University of Ahvaz dormitory, Golestan Blvd
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr Nader Saki
Street address
Vice Chancellor for Research, opposite the central building, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Salimeh Nezamivand-Chegini
Position
Master degree in midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
Nezamivandsalime@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Masoumeh Yaralizadeh
Position
master degree in midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
yaralizadeh.m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences,
Full name of responsible person
Masoumeh Yaralizadeh
Position
Master degree in midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
yaralizadeh.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)