Comparison of the effect of Primerose oil and Vitamin B6 versus placebo on premenstrual syndrome in girl college students: a double blind randomized clinical trial
Objectives: To compare the effect of Primerose oil and Vitamin B6 versus placebo on premenstrual syndrome in girl college students.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible girl college students with premenstrual syndrome who will educate in Hamadan University of Medical Sciences during the study period will be enrolled into the trial.
Inclusion criteria: age of 18 to 35 years; having regular menstrual cycle with 21 to 35 days interval.
Exclusion criteria: physical disease or using medications; psychological disease; using anti-depression drugs during past months; using hormonal drugs or vitamins.
Intervention group: (a) Primerose oil capsule 1000 mg twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles; (b) Vitamin D capsule 40 mg twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles.
Control group: Placebo capsule twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles
Primary outcome: severity of symptoms of premenstrual syndrome before intervention and 1 and 2 months after intervention using standard diagnostic questionnaire for premenstrual syndrome.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Participants will be unaware of the type of intervention. The examiner who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610289014N127
Registration date:2016-10-31, 1395/08/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Primerose oil and Vitamin B6 versus placebo on premenstrual syndrome in girl college students: a double blind randomized clinical trial
Public title
Comparison of the effect of Primerose oil and Vitamin B6 versus placebo on premenstrual syndrome in girl college students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 35 years; having regular menstrual cycle with 21 to 35 days interval.
Exclusion criteria: physical disease or using medications; psychological disease; using anti-depression drugs during past months; using hormonal drugs or vitamins.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Participants will be unaware of the type of intervention. The examiner who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.UMSHA.REC.1395.321
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
severity of symptoms of premenstrual syndrome
Timepoint
before intervention and 1 and 2 months after intervention
Method of measurement
using standard diagnostic questionnaire for premenstrual syndrome
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Primerose oil capsule 1000 mg twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin D capsule 40 mg twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles
Category
Treatment - Drugs
3
Description
Control group: Placebo capsule twice a day from 14 days before menstruation to 5 days after menstruation for two consecutive cycles
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
School of Nursing and Midwifery
Full name of responsible person
Arezoo Shayan
Position
Midwife
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
arezoo.shayan2012@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Arezoo Shayan
Position
Midwife
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
arezoo.shayan2012@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)