Study the effectiveness of Ginger on PMS symptoms is object of this study. Cases fill the DSRP (Daily record of Severity of Problems) questionnaire for calculating the severity of PMS symptoms. Cases fill the questionnaire 2 menstrual cycles before treatment. Those that have PMS syndrome, were choose. Cases divide in two Group (A, B). One group receive capsules containing ginger and other group receive placebo. Cases take drugs or placebo for two months. At the end of each month cases fill the questionnaire. After that taking drugs are discontinued for two months, then groups change their treatments (ginger and placebo) and continue taking them for two other cycles. Finally PMS results before and after treatment were calculated and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092119240N1
Registration date:2014-11-01, 1393/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-01, 1393/08/10
Registrant information
Name
Omid Gholami
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 6070
Email address
gholamio@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and technology, Sabzevar uniersity of medical sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of Gingiber powder capsules on Premenstrual Syndrome in students of Sabzevar University of Medical Sciences
Public title
Study the effect of Gingiber powder capsules on Premenstrual Syndrome in students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Regular menses period, No pregnancy or lactation, at least 3 years after menark, No history of psychological disorders, No Alcohol or tobacco use, No history of systemic disorder, No history of contraceptive use, No history of food preparation containing Ginger
Exclusion Criteria: Chronic disorder, Inflammatory pelvic disease, Taking specific drug,Having Infection, inflammation and Psychological disorder
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Cases divided in two group (intervention and control) randomly.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar Uniersity of Medical Sciences
Street address
Deputy of Research and Technology, Building No.1, University of Medical Sciences, Sabzevar
City
Sabzevar
Postal code
9613873136
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
medsab.Rec.92.37
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
F38.8
ICD-10 code description
Other specified mood [affective] disorders
Primary outcomes
1
Description
Physical symptoms
Timepoint
At the end of each period, for two consecutive period
Method of measurement
Standard Questionnaire
Secondary outcomes
1
Description
Behavioral and Psychological symptoms
Timepoint
Before intervention, at the end of each period for two consecutive period
Method of measurement
Standard Questionnaire
Intervention groups
1
Description
Intervention group:250mg ginger rhizome, every day, three times a day, for two menstrual period
Category
Treatment - Drugs
2
Description
Control group: placebo (lactose), every day, three times a day, for two menstrual period
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholami
Street address
Faculty of Medicine, Deputy of Education, Sabzevar University of Medical Sciences
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Sabzevar University Of Medical Sciences
Full name of responsible person
Mohammad Mohammadzadeh
Street address
Deputy of Research and Technology, Sabzevar University of Medical Sciences
City
Sabzevar
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 of Sabzevar 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
Sabzevar university of medical sciences
Full name of responsible person
Omid Gholami
Position
Assisstant professor
Other areas of specialty/work
Street address
Faculty of Medicine, Deputy of Education, Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
omidghphd@gmail.com; dromidgholami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholami
Position
Assisstant Professor
Other areas of specialty/work
Street address
Faculty of Medicine, Deputy of Education, Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
omidghphd@gmail.com; dromidgholami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar university of medical sciences
Full name of responsible person
Omid Gholami
Position
Assisstant professor
Other areas of specialty/work
Street address
Faculty of Medicine, Deputy of Education, Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
omidghphd@gmail.com; dromidgholami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)