The objective of this study was to investigate the valerian effect (valerin root) on the premenstrual symptoms among female university student living in dormitories of rasht islamic azad university.
In this double blind randomized clinical trial 120 female university students ,whose PMS were diagnosed by dickerson PMS daily record questionnaire for 2 menstrual, were randomly assigend into one of the two study group.one group received a valerian capsule (530 mg valerian root)for 2 months continuosly(twice a day).the control group received placebo capsule (50 mg of carbohydrate) using a similar protocol.The severity of premenstrual symptom were recorded befor and after the intervention and changes were compared between group
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120613196N1
Registration date:2013-12-14, 1392/09/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-14, 1392/09/23
Registrant information
Name
Seyedeh Bahareh Kamranpour
Name of organization / entity
Islamic Azad University Rasht Branch
Country
Iran (Islamic Republic of)
Phone
+98 13 1550 7590
Email address
kamranpour@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Rasht
Expected recruitment start date
2013-11-16, 1392/08/25
Expected recruitment end date
2014-03-16, 1392/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
valerian effect on the premenstrual symptoms amang female university student living in dormitories of rasht islamic azad university
Public title
valerian effect on the premenstrual symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: girls living in student residences
no major underlying diseases; not taking any medication to relieve premenstrual symptom; having regular menstrual cycles; not having genital diseases; non-smoking; willingness to participate in the study; completed a written informed consent.
Exclusion criteria: using hormone drugs; taking antidepressant; having premenstrual symptoms more than 7 day in each cycle; developing tensions and severe psychological crisis within the past few months.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Rasht
Street address
pole taleshan -islamic azad university of rasht
City
rasht
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
17/16/1/17238
Health conditions studied
1
Description of health condition studied
premenstrual syndrom
ICD-10 code
N94.3
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
mood symptoms of PMS
Timepoint
2 month befor intervention-2 month after intervention
Method of measurement
Dickerson standard questionnaire
Secondary outcomes
1
Description
physical symptoms of PMS
Timepoint
2 month befor intervantion-2 month after intervention
Method of measurement
Dickerson standard questionnaire
Intervention groups
1
Description
intervantion group: valerian capsule (530 mg valerian root) twice a day for a week before menstruation for two consecutive cycles
Category
Treatment - Drugs
2
Description
control group: placebo capsul (50 mg of carbohydrate)twice a day for a week before menstruation for two consecutive cycles
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad university of rasht
Full name of responsible person
seid bahare kamranpour
Street address
pole talesha-azad university
City
rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of azad university
Full name of responsible person
Dr shabani
Street address
pole taleshan
City
rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of azad university
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
Islamic Azad university of rasht
Full name of responsible person
seied bahare kamranpour
Position
MSc, Department of Midwifery -Lecturer, Department of Midwifery
Other areas of specialty/work
Street address
rasht- pole taleshan.Islamic Azad university
City
rasht
Postal code
Phone
+98 13 1550 7590
Fax
Email
kamranpour801@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad university of rasht
Full name of responsible person
seied bahare kamranpour
Position
MSc, Department of Midwifery -Lecturer, Department of Midwifery
Other areas of specialty/work
Street address
Islamic Azad university of rasht
City
rash
Postal code
Phone
+98 13 1550 7590
Fax
+98 13 1222 5047
Email
kamranpour801@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad university of rasht
Full name of responsible person
seied bahare kamranpour
Position
MSc, Department of Midwifery -Lecturer, Department of Midwifery
Other areas of specialty/work
Street address
rasht- pole taleshan.Islamic Azad university
City
rasht
Postal code
Phone
+98 13 1550 7590
Fax
+98 13 1222 5047
Email
kamranpour801@yahoo.coml.farzad59@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)