This is a randomize, double- blind, placebo-control, parallel-group study conducting on students with moderate and severe primary dysmenorrhea residing in dormitories of Shahed University. Subjects are selecting through a questionnaire which including demographic and menstrual cycle characteristics and grading of dysmenorrhea. Grading of dysmenorrhea are determine by verbal multidimensional scoring system and subjects who are grading moderate and severe dysmenorrhea are randomly allocating into two groups that receiving the Zingiber capsule and the placebo capsule. Severity of pain is determining by a visual analogue scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105266206N3
Registration date:2011-07-10, 1390/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-10, 1390/04/19
Registrant information
Name
Parvin Rahnama
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8587
Email address
prahnama@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2008-06-21, 1387/04/01
Expected recruitment end date
2009-02-18, 1387/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Zingiber officinal R. root on primary dysmenorrhea
Public title
effect of ginger on pain relief in primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Students with (aged 18 and over), primary and moderate to severe dysmenorrhea (score 2 or 3), regular period, and single are including in this study.
Exclusion criteria are a pre-existing diagnose disease, history of gestation or taking oral contraceptives, body mass index (BMI)<19 or>26, and mild dysmenorrhea
Age
From 18 years old to 32 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
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
Shahed University
Street address
Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway
City
Tehran
Postal code
Approval date
2006-08-15, 1385/05/24
Ethics committee reference number
150/828
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
pain
Timepoint
After treatment
Method of measurement
The visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The ginger is receiving 500 mg capsules of ginger powders three times in two different treatment protocols. Both the treatment protocols are conducting on the same patients with one month interval between the protocols.
Treatment protocol 1: In this protocol ginger is giving two days before and continuing through the three days from starting menstrual period. In the second protocol ginger is giving for the first three days of the menstrual period.
Treatment protocol 2: In this protocol ginger is giving for the first three days of the menstrual period.
Category
Treatment - Drugs
2
Description
The placebo is receiving 500 mg capsules of placebo powders three times in two different treatment protocols. Both the treatment protocols are conducting on the same patients with one month interval between the protocols.
Treatment protocol 1: In this protocol placebo is giving two days before and continuing through the three days from starting menstrual period. In the second protocol placebo is giving for the first three days of the menstrual period.
Treatment protocol 2: In this protocol placebo is giving for the first three days of the menstrual period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dormitory of Shahed University
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Herbal Research Center, Shahed University
Full name of responsible person
Ghlamali Naderi
Street address
Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Herbal Research Center, Shahed 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
shahed University
Full name of responsible person
Parvin Rahnama
Position
Ph.D
Other areas of specialty/work
Street address
Rahimzadeh st., Valie Asre st., Faculty of Nursing and Midwifery, Shahed University
City
Tehran
Postal code
Phone
+98 21 6641 8587
Fax
Email
prahnama@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Parvin Rahnama
Position
Ph.D
Other areas of specialty/work
Street address
Rahimzadeh st., Valie Asre st., Faculty of Nursing and Midwifery, Shahed University
City
Tehran
Postal code
Phone
+98 21 6641 8587
Fax
Email
prahnama@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Parvin Rahnama
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)