A comparative study on the effects of “Omega-3” and “Calcium” supplements to improve symptoms of primary dysmenorrhea in women referred to Gynecology clinic of Fatemieh hospital Hamedan, 2016
The objective of this study is to compare the effects of two different supplements; omega 3 and calcium on primary dysmenorrhea. Main inclusion criteria are: age 18-35 and having mild to moderate primary dysmenorrhea and the main exclusion criteria are Changing Participant's mind for any reason and at any time and having any hypersensitivity to supplements in this study. In this randomized, double blind trial 80 women with primary dysmenorrhea are randomly divided into two interventional groups of 40. Each group is matched according to age, duration of cycles, length of menstruation, and BMI of candidates. Drugs are placed in the similar packets, encoding with A and B. Packets are given to the gynecologist and she will open the packets and read the code of each group. Group A is given Ibuprofen 400 mg plus 1000 mg Omega 3 and group B given Ibuprofen 400 mg plus 1000 mg Calcium. The objective drug and supplements are given everyday in the first cycle and from 8 days before till 2 days after initiation of menstruation for the second and third cycles. The intensity of pain and other symptoms like nausea, vomiting, mastalgia, headache or acne are recorded once before treatment and then after each menstruation period and measured by the visual analogue scale (VAS). At the end of the study recorded points are evaluated and statistically analyzed and superior treatment will be suggested.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042327539N1
Registration date:2016-06-04, 1395/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-04, 1395/03/15
Registrant information
Name
Amir Reza Fallahian
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3525 0182
Email address
arf@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2016-05-15, 1395/02/26
Expected recruitment end date
2016-12-16, 1395/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of “Omega-3” and “Calcium” supplements to improve symptoms of primary dysmenorrhea in women referred to Gynecology clinic of Fatemieh hospital Hamedan, 2016
Public title
To compare the effects of “Omega-3” and “Calcium” supplements to improve primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18-35; Having mild to moderate primary dysmenorrhea; Not taking any medication to reduce mesturation pain except ibuprofen 400 mg
not taking any omega3 and calcium supplement; Not having co-morbidity (secondary dysmenorrhea). Exclusion critria: Changing Participant's mind for any reason and at any time; Any hypersensitivity to the drugs in this study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Ayatollah kashani blv, Khaje rashid cross
City
Hamadan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.UMSHA.REC.1395.93
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Intensity of Dysmenorrhea
Timepoint
Pre and Post interventional phase (two menstrual cycle)
400 mg Ibuprofen plus 1000 mg Omega 3 daily in the first month and from 8 days before till 2 days after menstruation for the second and third cycles will be given
Category
Treatment - Drugs
2
Description
400 mg Ibuprofen plus 1000 mg Calcium daily in the first month and for the second and third cycles from 8 days before till 2 days after menstruation will be given
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Fatemieh Hospital
Full name of responsible person
D. Azami Fard
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amir Reza Fallahian
Street address
Ilia apartment, Laleh alley, Shahid nazemi, pasdaran street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Science
Full name of responsible person
Amir Reza Fallahian
Position
Investigator
Other areas of specialty/work
Street address
Ilia apartment, Laleh alley, Shahid nazemi, pasdaran street
City
Hamedan
Postal code
Phone
+98 81 3827 8790
Fax
Email
amirrezafallahian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Dr. Maryam Mehrpooya
Position
Clinical Pharmacist/ Phd
Other areas of specialty/work
Street address
Hamedan University of Medical Science
City
Hamedan
Postal code
Phone
+98 81 3838 1673
Fax
Email
m.mehrpoya@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Nasrin Azami Fard
Position
Student
Other areas of specialty/work
Street address
Ilia apartment, Laleh alley, shahid Nazemi, Pasdaran street
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)