The purpose of the study is to compare the effect of "Gharasaneh" Syrup with Ibuprofen Syrup and placebo on primary dysmenorrhea. One hundred fifty 30-18years old students, who are resident in dormitory with considering inclusion and exclusion criteria, will enter the study. Enrolling in 3 groups of "Gharasaneh" Syrup, Ibuprofen Syrup and placebo cases will be done with simple sampling and random allocation. Design and performance of the study are double blind. The cases are obtained written informed consent and will explain them that enrolling in the groups is randomly.
The forms of Demographic information will be completed and also history of dysmenorrhea including the severity of pain (based on Visual Analogue Scale) and the time duration of pain in the last menstrual cycle before enrolling in to the study.
The dosages in three groups are 10 ml TDS. They will be prescribed 3 days before probable bleeding time up to the 3rd day of bleeding. The treatment is continued for2 consecutive cycles.
Pain severity is measured at the end of first and second months of medication and two consecutive menstrual cycles after the study and will compared with the baseline data.
The study design is founding on Acetaminophen consumption as Rescue Dose and reporting the dosage of it in Placebo and "Gharasaneh" group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082823789N1
Registration date:2015-11-18, 1394/08/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-18, 1394/08/27
Registrant information
Name
Elham Behmanesh
Name of organization / entity
Babol University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
e.behmanesh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
School of Traditional Medicine
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-14, 1395/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eryngium Syrup on Primery Dysmenorrhea and comparison with Ibuprofen Syrup; Clinical Control Trial
Public title
The effect of "Gharasaneh" Syrup on Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age between 18 to 30; Primary dysmenorrhea (pain is started 1 to 2 years after menarche during the menstruation and dose not appear any other time)
exclusion criteria:Heavy exercise; Taking other drugs during the study; Concomitant use of hormonal contraceptive methods; History of allergy to herbal medicine; Severe stress (Such as the loss of a close relative, Intense familial debate, some other stress factor during recent 6 months)
Age
From 18 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Babol University of Medical Science-Deputy Ministry for Research and Technology
Street address
Ganjafrooz Street, University of Medical Sciences
City
Babol
Postal code
47745-47176
Approval date
2015-07-28, 1394/05/06
Ethics committee reference number
Mubabol.rec.1394.113
Health conditions studied
1
Description of health condition studied
dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
severity of pain
Timepoint
Before intervention, 2 month after begining intrvention
Method of measurement
Visual Analogue scale
2
Description
severity of pain
Timepoint
first menstural cycle after study
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
"Gharasaneh" syrup; it will be prescribed 3 days before probable bleeding time up to the 3rd day of bleeding. The dosage is 10 ml TDS. The treatment is continued for 2 consecutive cycles.
Category
Treatment - Drugs
2
Description
Ibuprofen syrup (200mg/5cc); it will be prescribed 3 days before probable bleeding time up to the 3rd day of bleeding. The dosage is 10 ml TDS. The treatment is continued for 2 consecutive cycles.
Category
Treatment - Drugs
3
Description
Placebo syrup; it will be prescribed 3 days before probable bleeding time up to the 3rd day of bleeding. The dosage is 10 ml TDS. The treatment is continued for 2 consecutive cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Female Dormatory of Tehran University
Full name of responsible person
Elham Behmanesh
Street address
End of Kargar St, Tehran University dormatory
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Scienses
Full name of responsible person
Dr. Ali Bijani
Street address
Ganjafrooz Street, Babol University of Medical Sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Scienses
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
Elham Behmanesh
Position
Student
Other areas of specialty/work
Street address
Ganjafrooz Street, Babol University of Medical Sciences
City
Babol
Postal code
47745-47176
Phone
+98 11321995926
Fax
+98 11 3219 0181
Email
e.behmanesh@mubabol.ac.irbehmanesh_e@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
General physician
Other areas of specialty/work
Street address
Ganjafrooz Street, Babol University of Medical Sciences