The comparison of Shirazi Thymus Vulgaris and Ibuprofen effects on the severity of primary dysmenorrhea n female student campuses Ilam University of Medical scinces in 2009
Background: Primary dysmenorrhea defined as painful cramps during menstruation with no pelvic pathology. The Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are considered the most common pharmacologic treatment. The present study was conducted to compare the effects of Shirazi Thymus Vulgaris and Ibuprofen on primary dysmenorrhea due to adverse effects of NSAIDs.
Methods and Materials: A randomized, single-blind clinical trial was conducted amongst 120 female students at the Ilam University of Medical Sciences campuses, aged 18 to 25 years who suffered from primary dysmenorrhea. Inclusion criteria including: suffered from primary dysmenorrhea
;single;Ilam University of Medical Sciences campuses and excluding criteria including: Diabetes mellitus;taking certain medications;stressors in the past three months;irregular menstruation ;abnormal discharge The participants were randomly divided into two groups of herbal and classic treatments. The first herbal group received the Shirazi Thymus Vulgaris commercially named BronchoT.D 5cc orally QID. The second classic group received Ibuprofen; three tablets orally daily. A visual analogue scale (VAS) was used to record pain severity.Systemic symptoms were compared using multi-dimensional measure during two consecutive menstrual cycles.Data were analyzed using descriptive statistics, inferential, statistical inference, indicators mean and SD and Whitney test, Friedman and Wilcoxon
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105236575N1
Registration date:2011-06-13, 1390/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-13, 1390/03/23
Registrant information
Name
Ashraf Direkvand-Moghadam
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
direkvand-a@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ilam University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Shirazi Thymus Vulgaris and Ibuprofen effects on the severity of primary dysmenorrhea n female student campuses Ilam University of Medical scinces in 2009
Public title
The comparison of Shirazi Thymus Vulgaris and Ibuprofen effects on the severity of primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffered from primary dysmenorrhea
; single;Ilam University of Medical Sciences campuses; Excluding criteria: Diabetes mellitus;taking certain medications;stressors in the past three months;irregular menstruation ;abnormal discharge
Age
From 18 years old to 25 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
the Ilam University of Medical Sciences
Street address
the Ilam University of Medical Sciences
City
Ilam
Postal code
Approval date
2008-10-11, 1387/07/20
Ethics committee reference number
5195/40/22
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Dysmenorrhea severity
Timepoint
Two months before the intervention and intervention for two consecutive menstrual cycles
Method of measurement
VAS method
Secondary outcomes
1
Description
duration of pain
Timepoint
Two months before the intervention and intervention for two consecutive menstrual cycles
Method of measurement
Cox Menstrual Symptom Scale
Intervention groups
1
Description
classic group received Ibuprofen; three tablets orally daily from the first day until had pain score more than 3 during menstruation
Category
Treatment - Drugs
2
Description
The herbal group received the Shirazi Thymus Vulgaris commercially named BronchoT.D 5cc orally QID from the first day until had pain score more than 3 during menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar, Ilam University of Medical Sciences campuse
Full name of responsible person
BA of Midwifery
Street address
Kosar campuses.Ilam University of Medical Sciences
City
Ilam
2
Recruitment center
Name of recruitment center
Hejab campuse.Ilam University of Medical Sciences
Full name of responsible person
BA of Midwifery
Street address
Hejab campuse.Ilam University of Medical Sciences
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ilam University of Medical Sciences
Full name of responsible person
Dr Afra Khosravi research manager of research, Ilam University of Medical Sciences
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
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, Ilam 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
Department of Midwifery,Faculty of Nursing and Midwifery,Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam (MSc)
Position
MSc
Other areas of specialty/work
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Midwifery,Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc
Other areas of specialty/work
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
direkvand-a@medilam.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Ashraf Direkvand-Moghadam
Position
MSc midwifery
Other areas of specialty/work
Street address
Vice chancellor for research Ilam University of Medical Sciences, Pajuhesh Avenue, Bangnjab, Ilam
City
Ilam
Postal code
6931157387
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)