Premenstrual syndrome (PMS) includes the physical and emotional symptoms that affect women before menstruation. Different treatments were suggested for reducing the symptoms, including medical, surgical and complementary therapy. The aim of this study was to compare the effects of Echinophora platyloba and fenilin in reducing PMS in students of Shahrekord University of medical sciences in 2007-2008. At first 250 of students were assessed by DRSP questionnaire for PMS syndrome and in the next stage 90 students who had severe symptoms, were selected and randomly divided in three groups. The first group received the Echinophora platyloba extract for two month. In similar conditions, the second group received the fenilin extract and the third group received placebo. After 2 months severity of PMS symptoms were compared with their severity before the start of the treatment. For data analysis, we used SPSS software. Keywords: PMS, Echinophora platyloba, fenilin, students
General information
Acronym
premenstural tension syndrome
IRCT registration information
IRCT registration number:IRCT138810263078N1
Registration date:2010-05-20, 1389/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-20, 1389/02/30
Registrant information
Name
Masoumeh Delaram
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
mdelaram@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
shahrekord university of medical sciences
Expected recruitment start date
2008-02-20, 1386/12/01
Expected recruitment end date
2009-03-05, 1387/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of echinophora platyloba and fennilin on the severity of premenstrual syndrome
Public title
Comparison of the effect of echinophora platyloba and fennilin on the severity of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
1) Students with moderate to severe premenstural syndrome
2) Age between 18-25
3) Not married
Age
From 18 years old to 25 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of medical sciences , 352 A P , 3.1.2008
Street address
Rahmateeyeh
City
Shahrekord
Postal code
8813833435
Approval date
empty
Ethics committee reference number
352/آ/پ : کد کمیته اخلاق : 3-1-87
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
Measured severity of premenstrual syndrome
Timepoint
Two month befores intervention and 2 month after intervention given
Method of measurement
DRSP questionnaire
Secondary outcomes
1
Description
Measured severity of premenstrual syndrome
Timepoint
every month for 4 months
Method of measurement
using the information records
Intervention groups
1
Description
Recieving the fenilin
Category
Treatment - Drugs
2
Description
Recieving the Echinophora Platiloba
Category
Treatment - Drugs
3
Description
Recieving placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord University of Medical Sciences dormitories
Full name of responsible person
Masoumeh Delaram
Street address
Rahmateeyeh, Shahrekord university of medical sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Masoumeh Delaram
Street address
Rahmatieh
City
Shahrekord
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of medical sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc in midwifery, Academic member
Other areas of specialty/work
Street address
Rahmateeyeh, Shahrekord University of medical sciences, School of Nursing and Midwifery
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.com; mdelaram@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of medical sciences
Full name of responsible person
Farkhondeh Jafari (MD)
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Parastar Avenue, Hajar hospital
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.com
Web page address
www.kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Masoumeh Delaram
Position
M.Sc in midwifery, Academic member
Other areas of specialty/work
Street address
Rahmateeyeh, Shahrekord university of medical sciences
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
masoumehdelaram@yahoo.com; mdelaram@skums.ac.ir
Web page address
www.skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)