In this clinical trial the effect of thyme essential oil (zataria-multiflora) is being evaluated in the treatment of premenstrual syndrome. Samples of 120 students of Isfahan University of Medical Sciences dormitories (age range 35-18 years) who are afflicted with the Temporary diagnostic questionnaire If this syndrome. Inclusion criteria: having a regular menstrual intervals of 35-21 days;the lack of physical disease or taking certain medications; no history of mental illness; no use of any anti depressants or hormonal drugs; no experience of stressful event during last 3 month from the beginning of the study. Exclusion criteria: hospitalization; pregnant; No experience stress during the study. In the intervention and control groups were randomly placed. The intervention group receives 2 Capsules thyme 20 mg every 12 hours (dose 80 mg daily) and controls placebo than 7 days prior to the onset of menstrual periods, taking. Severe symptoms of premenstrual syndrome symptoms daily using the form registration table for 4 cycles (2 cycles before treatment and after 2 cycles of therapy) will be completed by the subjects. After calculating the overall severity of symptoms, signs, symptoms, physical separation, emotional - affective and behavioral classification and its intensity is calculated. Consequence of this reduction in the severity of affective, physical, behavioral PMS students.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102211212N1
Registration date:2012-12-24, 1391/10/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-24, 1391/10/04
Registrant information
Name
Marzieh Sodouri
Name of organization / entity
Kasahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
sodouri@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2012-10-19, 1391/07/28
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zataria-multiflora on premenstrual syndrome severity in the students of Isfahan University of Medical Sciences 1391-1392.
Public title
The effect of zataria-multiflora on premenstrual syndrome severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age range of 18-35 years; a mark of at least 5 of the questionnaire to detect symptoms of temporary Pms; that at least one of the five symptoms of psychiatric symptoms and the severity of each offense included within the average or more during the past two months ; having a regular menstrual cycle; lack of stressor during the previous 3 months; lack of physical illness and mental; Non-hormonal medications and anti depressants.
Exclusion criteria: Persons who during the study Getting sick; being hospitalized;being pregnant; the reading experience of be stressful; those who do not use the medicine properly; or do not complete the form correctly.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
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
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
87159/88141
Approval date
2012-10-17, 1391/07/26
Ethics committee reference number
29/5/1/2735
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
The severity of premenstrual syndrome
Timepoint
2 months before the study, 2 months after the intervention
Method of measurement
Daily chart position
Secondary outcomes
empty
Intervention groups
1
Description
Control group: placebo capsules 2 times a day (2 tablets every 12 hours) for 7 days prior to the first day of the menstrual cycle
Category
Treatment - Drugs
2
Description
Soft capsules containing 20 mg of essential oil and 2 times a day (every 12 hours 2 tablets) for 7 days prior to the first day of the menstrual cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermani Dormitory, Isfahan University of Medical Sciences
Full name of responsible person
Marzieh Sodouri
Street address
Shiraz Gateways,Hezarjarib Street
City
Isfahan
2
Recruitment center
Name of recruitment center
Milad Dormitory, Isfahan University of Medical Sciences
Full name of responsible person
Marzieh Sodouri
Street address
Shiraz Gateways,Hezarjarib Street
City
Isfahan
3
Recruitment center
Name of recruitment center
Seyed Shohada Dormitory, Isfahan University of Medical Sciences
Full name of responsible person
Marzieh Sodouri
Street address
Motahari Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr.Gholamali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.
City
Kashan
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, Kashan University of Medical Sciences