Evaluating the effect of vitex agnus castus on treatment of premenstrual syndrome among students of Tehran University of Medical Sciences and Tehran University
Objective: to evaluate the effect of Vitex on treatment of premenstrual syndrome.
Design: Randomized, double blind, placebo controlled, parallel group comparison.
116 students of Tehran University of Medical Sciences and Tehran University living in dormitory were included in this study. Participants underwent a preliminary screening interview, completed Daily Symptom Rating (DSR) for two cycles, and attended in medical screening visit and screening for depression by Beck questionnaire. 116 eligible students were randomly divided in two groups of 58 people. Participants took tablets of Vitex daily or matching placebo for two cycles. Finally 49 participants in active and 50 in placebo group completed study.
Inclusion criteria: Single students of at least 18 years old, with regular menstruation and confirmed diagnosis of pms were included. Diagnosed physical or mental diseases, using hormonal drugs, vitamins, herbal drugs and participation in other same trials were among exclusion criteria.
Main Outcome Measures: psychological, physical and total symptoms of premenstrual syndrome were assessed before (two screening cycles) and after treatment (two treatment cycles) via Daily Symptoms Rating (DSR) contain 18 symptoms of premenstrual syndrome (10 psychological and 8 physical symptoms).
General information
Acronym
Evaluating the effect of vitex agnus castus on treatment of premenstrual syndrome
IRCT registration information
IRCT registration number:IRCT201101035541N1
Registration date:2011-03-31, 1390/01/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-31, 1390/01/11
Registrant information
Name
Maryam Moradi
Name of organization / entity
Australian National University
Country
Australia
Phone
0061430679650
Email address
maryam.moradi@anu.edu.au
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2006-06-22, 1385/04/01
Expected recruitment end date
2007-03-06, 1385/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitex agnus castus on treatment of premenstrual syndrome among students of Tehran University of Medical Sciences and Tehran University
Public title
Evaluating the effect of vitex agnus castus on treatment of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Age 18 and above
2- Single
3- Regular menstruation (interval: 24-35 days, duration: 2-8 days) in last year
4- Contemporary diagnosis of pms based on DSM-IV
5- Confirmed diagnosis of pms based on two screening cycles
Exclusion criteria:
1- Diagnosed physical or mental diseases
2- Using hormonal drugs, agonist or antagonist of dopamine ,or vitamins
3- Using antidepressant or herbal drugs
4- Participation in other same trials
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In treatment stage 116 eligible participants were randomly divided to two groups. Participants took vitex agnus castus one tablet daily or matching placebo for two cycles.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Tehran University of Medical Sciences
Street address
6th Floor, Central Organization of University,Ghods Street,Keshavarz BLV,Tel:88987381
City
Tehran
Postal code
فاکس:0098218898966
Approval date
2006-10-10, 1385/07/18
Ethics committee reference number
6673/132
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
total symptoms of premenstrual syndrome
Timepoint
before treatment (two screening cycles)and after treatment (two treatment cycles)
Method of measurement
Daily Symptoms Rating(DSR)contain 18 symptoms of premenstrual syndrome (10 psychological and 8 physical symptoms)
2
Description
psychological symptoms of premenstrual syndrome
Timepoint
before treatment (two screening cycles)and after treatment (two treatment cycles)
Participants in drug group took tablet of vitex agnus castus made by Goldaru pharmaceutical Company in Esfahan (contain 3.2- 4.8 mg dry extract of vitex fruit, equal 0.42-0.58 mg Aucubin), one tablet daily for two cycles.
Category
Treatment - Drugs
2
Description
Participants in placebo group took tablet of placebo made by Goldaru Pharmaceutical Company in Esfahan (contain Magnesium Astyaarat 1 % and Starch), one tablet daily for two cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory of Tehran University of Medical Sciences
Full name of responsible person
Maryam Moradi
Street address
Enghelab Square,Koye Daneshghah,
City
Tehran
2
Recruitment center
Name of recruitment center
Dormitory of Tehran University
Full name of responsible person
Maryam Moradi
Street address
Enghelab Square,Koye Daneshghah,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Chancellor
Street address
6th Floor, Central Organization of University,Ghods Street,Keshavarz BLV,Tel:88987381
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Australian National University
Full name of responsible person
Maryam Moradi
Position
Ms of Midwifery and PhD candidate at Australian National University
Other areas of specialty/work
Street address
Canberra,Australian National University
City
Canberra
Province
ACT
Postal code
Phone
061262443655
Fax
061262444960
Email
maryam.moradi@anu.edu.au
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Minoo Pakgohar
Position
Faculty member of Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Tohid Square, Nursing and Midwifery Faculty of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
+98 21 6696 5405
Email
mpakgohar@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery faculty of Tehran University of Medical Sciences
Full name of responsible person
Minoo Pakgohar
Position
faculty member of Nursing and Midwifery faculty of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Tohid Square,Nursing and Midwifery faculty of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
+98 21 6696 5405
Email
mpakgohar@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)