The aim of this study was to investigate the effect of ginger on the severity of pain among women with primary dysmenorrhea. Design: randomized and double blind clinical trial. Study population: the girl students of Qazvin University of Medical Sciences who are informed consentfully enter the study. Main inclusion criteria: Students at the age of 18 and 30 years who have moderate and severe dysmenorrhea. Exclusion criteria: underlying disease; using contraceptive pills and any analgesic medications. Method: this research was performed on 100 girls with primary dysmenorrhea, who were selected by simple sampling method and randomly assigned to one of two intervention and control groups. Medications were encoded in separate envelopes and delivered to the participants. The participants and the individuals supplied the medication, didn’t not know the type of drug in the envelope. In the intervention group, ginger herbal oral tablet, manufactured by the Dinaineh Pharmaceutical Company, Iran was administered at the dose of 500 mg twice a day for 5 days. In the control group, 2 placebo tablets were given similar to the ginger pill that was manufactured by the same pharmaceutical company. As participants in the study had moderate and severe dysmenorrhea, mefenamic acid 250 mg capsule was prescribed to both groups twice a day for 5 days for ethical consideration. Intervention time: 2 monthly cycles. Initial outcome: severity of pain at the beginning and at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612118611N4
Registration date:2017-09-11, 1396/06/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Qazvin University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ginger and placebo on the severity of dysmenorrhea in medical girl students
Public title
The effect of ginger on the pain of menstruation in medical girl students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18- 30 year old single girls with a regular menstruation cycles of 21- 35 days; duration of 3-7 days, with moderate or severe dysmenorrhea were entered the study. Exclusion criteria: underlying disease; using contraceptive pills and any analgesic medications; drug and herbal susceptibility.
Age
No age limit
Gender
Female
Phase
N/A
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
Medications are encoded in separate envelopes and delivered to the participants. The participants and the individuals who supply the medication do not know the type of drug in the envelope.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.QUMS.REC.1395.205
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
Severity of pain
Timepoint
Monthly
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group, ginger tablets will be given 500 mg twice a day and 250 mg mefenamic acid capsule twice a day, from 2 days before menstruation to 3th day of menstruation.
Category
Placebo
2
Description
Control group: In the control group, placebo will be given 500 mg twice a day and 250 mg mefenamic acid capsule twice a day, from 2 days before menstruation to 3th day of menstruation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
The girls of Qazvin University of Medical Sciences
Full name of responsible person
Dr Hamideh Pakniat
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Naser Taghi poor farivar
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
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 of Qazvin 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
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 32236374
Fax
Email
pakniat110@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 3223 6374
Fax
Email
pakniat110@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
3415613176
Phone
00
Fax
Email
pakniat110@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)