This study aimed to determine the effect of Vitagnus on premenstrual syndrome in female students of Shahid Chamran dorm, and it was conducted as a double-blind clinical trial.. Inclusion criterion: Female students suffering PMS with regular menstrual cycle and exclusion criteria: current psychotherapy, breast feeding/pregnancy, taking sexual hormones, having stress in the past three months (e.g. death, marriage or surgery of close relatives),. In this study, after completing the questionnaire twice during three consecutive menstrual cycles, 72, daughter of Shahid Chamran dormitory students who 25_18 years of age, suffering from moderate to severe premenstrual syndrome and the conditions for inclusion were selected and then randomly divided into experimental and control groups were 36. Case group was prescribed with 40 drops of Vitagnus daily for three menstrual cycles, while the control group was given placebo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102219632N1
Registration date:2015-02-04, 1393/11/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Parvaneh Mousavi
Name of organization / entity
Ahvaz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 4902
Email address
mousavi-p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Reseach Deputy of Ahvaz University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of Vitagnus on premenstrual syndrome in female students of Shahid Chamran dormitory
Public title
Vitagnus effect on premenstrual symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: students with premenstrual syndrome with regular menstrual cycle. exclusion criteria: Psychotherapy with pregnancy or breastfeeding; use of hormones; stress in the recent quarter such as marriage or the death of someone close surgery; patients taking certain medications such as dopamine antagonists used
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
Ahvaz University of Medical Sciences، Esfand Street، Golestan
City
Ahvaz
Postal code
Approval date
2003-01-21, 1381/11/01
Ethics committee reference number
278
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Unspecified condition associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
the severity of the symptoms of premenstrual syndrome
Timepoint
one؛ two Three months after intervention
Method of measurement
Recorded daily symptoms of PMS
Secondary outcomes
1
Description
Side effects include itching, dizziness, stomach pain, diarrhea
Timepoint
Two weeks until 1 mounth
Method of measurement
Phone calls and monthly views
Intervention groups
1
Description
Five finger test group oral drops to 40 drops a day for three menstrual cycles
Category
Treatment - Drugs
2
Description
A placebo control group, the intervention takes place
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls' dormitory University of Shahid Chamran
Full name of responsible person
Parvane Mousavi
Street address
Girls' dormitory University Of Shahid Chamran، Esfand Street، Golestan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University Of Medical Sciences
Full name of responsible person
Kouroosh Zare
Street address
Esfand Street، Golestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Position
Master of Science in Nursing / Academic
Other areas of specialty/work
Street address
Esfand Street، Golestan
City
Ahvaz
Postal code
Phone
+98 917 480 0362
Fax
Email
mousavi-p@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University Of Medical Sciences
Full name of responsible person
Parvaneh Mousavi
Position
Msc Abstetrics
Other areas of specialty/work
Street address
Esfand Street، Golestan
City
Ahvaz
Postal code
Phone
+98 917 480 0362
Fax
Email
mousavi-p@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Parvane Mousavi
Position
Msc Midwifery
Other areas of specialty/work
Street address
University Of Medical Science، Esfand Street، Golestan
City
Ahvaz
Postal code
Phone
+98 917 480 0362
Fax
Email
mousavi-p@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)