Introduction: primary dysmenorrhea is a common symptom in women of menstrual age and it occurs between 60-93 percent of female. This symptom usually begins at the start of menstruation, continues for a few days, and is characterized by pain that radiates from the lower abdomen to the inner thighs, is usually limited to the first 48 or 72 hours of menstruation. CAM treatments for dysmenorrhea that have been studied include transcutaneous electrical nerve stimulation (TENS), acupuncture, acupressure, spinal manipulation, behavioral interventions, and herbal and dietary therapies. This study is to evaluate the therapeutic effects of Stachys lvandulifolia on relief of primary dysmenorrhea. Method: participants were female students of Touyserkan Azad University in western Iran. The students were randomly assigned into control (45) and experimental (45) groups. Initially, the study population was requested to consume the Stachys lvandulifolia flowers at a dose of 10 gr of brewed powder three time a day and for a total of 5 days (2 days before pain to 3 days after pain), based on a common traditional administration. Later, the members of both groups were followed up for three cycles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312318360N3
Registration date:2014-01-04, 1392/10/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-04, 1392/10/14
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Islamic Azad university
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 1439
Email address
e.jenabi@tuyiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Touyserkan Azad University
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Stachys lavandulifolia on relief of primary dysmenorrheal
Public title
Effect of Stachys lavandulifolia on relief of primary dysmenorrheal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primary dysmenorrhea; being single and agree to participate in study.
Exclusion criteria: history of other diseases ; irigullar menstruation; drug use and mild dismenorrhea (1-3).
Age
From 19 years old to 25 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Islamic Azad university,Touyserkan Branch
Street address
touyserkan-azad university
City
Touyserkan
Postal code
Approval date
2012-07-31, 1391/05/10
Ethics committee reference number
14568/91
Health conditions studied
1
Description of health condition studied
Primary dismenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
dismenorrhea
Timepoint
2 day before of mens and 3 day of mens first
Method of measurement
Visual Analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Invention group: taking Stachys lavandulifolia (10 gram flowers in 1 glass of boil water)in 2 days before of mens and 3 days mens first
Category
Treatment - Drugs
2
Description
Control group: taking placebo 2 days before mens and 3 days of mens first.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad university of Touyserkan
Full name of responsible person
Street address
City
Touyserkan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Touyserkan Azad university
Full name of responsible person
Parisa Hejrati
Street address
Touyserkan Azad university
City
Touyserkan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Touyserkan Azad university
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
Azad University of Touyserkan
Full name of responsible person
Parisa Hejrati
Position
MSc
Other areas of specialty/work
Street address
Azad University of Touyserkan
City
Touyserkan
Postal code
Phone
+98 85 2422 0253
Fax
Email
hejratiparisa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azad University of Touyserkan
Full name of responsible person
Ensiyeh Jenabi
Position
MSc
Other areas of specialty/work
Street address
Touyserkan
City
Touyserkan
Postal code
Phone
+98 85 2422 0253
Fax
Email
enciehjenabi@yahoo.ca
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azad University of Touyserkan
Full name of responsible person
Ensiyeh Jenabi
Position
MSc
Other areas of specialty/work
Street address
Touyserkan- Azad University
City
Touyserkan
Postal code
Phone
+98 85 2422 0253
Fax
+98 85 2422 0253
Email
enciehjenabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)