The aim of this randomized, double blind trial is to investigate an alternate herbal treatment for dysmenorrehea. In this study, 84 patients with dysmenorrehea who meet the inclusion/exclusion criteria will be recruited and randomly assigned into the three following groups. The patients in the intervention group will receive origanum vulgare or Ibuprofen as well as placebo and the patients in the control group will receive placebo with similar form and dose. Intensity of dysmenorrhea will be measured by using visual analog scale (VAS) and compared between groups.
General information
Acronym
CSTVIPD
IRCT registration information
IRCT registration number:IRCT201101245683N1
Registration date:2011-06-03, 1390/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-03, 1390/03/13
Registrant information
Name
Hajar salmalian
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 112199595
Email address
h.salmalian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences, Barij Essence corporation, Kashan
Expected recruitment start date
2011-04-03, 1390/01/14
Expected recruitment end date
2011-10-06, 1390/07/14
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 primary dysmenorrheal (A double blind clinical trial)
Public title
An alternate herbal treatment for dysmenorrehea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single 18 to 24 years old midwifery and nursing students with no history of abdominal or pelvic surgery or any specific disease who were suffering from primary dysmenorrehea grade 1 or 2
Exclusion criteria: improper administration of the medication, administration of contraceptive pills or another medication whilst on research, history of allergies to origanum vulgare, severe stress, heavy exercise
Age
From 18 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
All individuals have the right to use their own medication of choice in case of no response to the intended treatment, though they are obliged to report the time and reason of administrating the new medication as well as their pain score prior to taking the drug.
Such individuals would not be eliminated from the study, they would be considered as failure to treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences
City
Babol
Postal code
4774547176
Approval date
2011-02-22, 1389/12/03
Ethics committee reference number
3150
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
O94-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Primary dysmenorrhea
Timepoint
Prior to the intervention, 2 months after the initiation of intervention (2 first days of 2 subsequent cycles)
Method of measurement
Visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
cap Ibuprofen 200 mg + 25 drop placebo (Orally administrated every 6 hours (PO,QID) in the first 2 days of 2 subsequent cycles.)
Category
Treatment - Drugs
2
Description
25 drops thymus vulgaris+ cap placebo 200 mg ( Orally administrated every 6 hours (PO,QID) in the first 2 days of 2 subsequent cycles)
Category
Treatment - Drugs
3
Description
25 drops placebo + cap placebo 200 mg (Orally administrated every 6 hours (PO,QID) in the first 2 days of 2 subsequent cycles.)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Hajar Salmalian- Midwifery MSc( Faculty Member)
Street address
Babol University of Medical Sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
8929912
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Roshanak Saghebi
Position
MD
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
4774547176
Phone
+98 11 1219 9595
Fax
+98 11 1219 9936
Email
h.salmalian@mubabol.ac.ir
Web page address
www.mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar salmalian
Position
Midwifery MSc-Faculty member
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
4774547176
Phone
+98 11 1219 9595
Fax
+98 11 1219 9936
Email
h.salmalian@mubabol.ac.ir
Web page address
www.mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar salmalian
Position
Midwifery MSc- Faculty member
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
4774547176
Phone
+98 11 1219 9595
Fax
+98 981112199936
Email
h.salmalian@mubabol.ac.ir
Web page address
www.mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)