Study purpose is comparing the effect of topical ginger oil with oral ginger on moderate and sever primary dysmenorrhea.
patients include grade 2,3 primary dysmenorrhea( based on Multidimensional Verbal Scoring System) according to history and pelvic sonography . And if they become pregnant or sensitize to medication or personal desire, they will exclude.
Study population is Shahid Beheshti university female students living in dormitory with dysmenorrhea. Sample size is 34 patients in each group and recalculated after the pilot on the 10 patients in each group.
At the first it was evaluated severity and duration of pain without intervention. Then Patients are divided stratified randomization (according to moderate and sever) between two groups: ginger capsule and ginger oil. Intervention in both groups is from two days before the onset of the menstrual period until the first three days every 6 hours that in capsule group: one 250 mg oral and in oil group: 5 drops on the abdomen under umbilicus for 3 consequent cycles. 12 mefenamic acid capsules were given to students in each cycles and it recorded and compared the number of mefenamic acid’s consumption. Intensity of pain based on VAS and duration of pain based on hour were evaluated the day before until the first three days of menstruation in every four cycles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090219012N1
Registration date:2015-05-16, 1394/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-16, 1394/02/26
Registrant information
Name
Pantea Shirooye
Name of organization / entity
School of Traditional Medicineو, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 488 7140
Email address
pshirooye@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of topical ginger oil with oral ginger on primary dysmenorrhea
Public title
Comparing the effect of topical ginger oil with oral ginger on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 18-45 years; BMI ≤ 35; regular menstrual cycles (21-35day) and Regular bleeding (3-10days) in the latest three menses; moderate and severe dysmenorrhea (grade 2,3) based on Multidimensional Verbal Scoring System; rejection of Secondary dysmenorrhea by history and pelvic ultrasound; no History of pelvic or abdominal surgery; not taking other medications; no history of allergy to ginger; no history of bleeding disease; no history of gallstone.
Exclusion Criteria: pregnancy; sensitivity to medication during the study; avoiding the correct use of medication; taking another drug that is not defined in the study; patients with Possible serious side effects; patients who need additional interventions and surgery; patients who decide to be excluded.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
next to Taleghani hospital, Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2015-01-04, 1393/10/14
Ethics committee reference number
163
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrha
Primary outcomes
1
Description
pain intensity
Timepoint
cycle before intervention, every cycles during intervention (3 cycles)
Method of measurement
VAS = visual analog scale
2
Description
pain duration
Timepoint
cycle before intervention, every cycles during intervention (3 cycles)
Method of measurement
hour
Secondary outcomes
1
Description
side effect: Stomachache, nasea, vomiting, hematemesis, belch, fatigue, itching, acne, heartburn, diarrhea, constipation, melena,headache, drowsiness, redness, assessment of bleeding with PBAC
Timepoint
cycle before intervention, every cycle during intervention (3 cycles)
Method of measurement
questionnaire
2
Description
Mefenamic asid use
Timepoint
cycle before intervention, every cycle during intervention (3 cycles)
Method of measurement
number
Intervention groups
1
Description
250 mg capsule of ginger every 6 hours from two days before the onset of the menstrual period until the first three days of the menstrual period for 3 consequent cycles
Category
Treatment - Drugs
2
Description
Ointment 5 drops ginger oil on the abdomen under umbilicus every 6 hours, from two days before the onset of the menstrual period until the first three days of the menstrual period for 3 consequent cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Zeinab dormitory
Full name of responsible person
Mrs Zaeem
Street address
zafar street
City
Tehran
2
Recruitment center
Name of recruitment center
Goleyas dormitory
Full name of responsible person
Mrs Zaeem
Street address
Vanak square
City
Tehran
3
Recruitment center
Name of recruitment center
Golenarges dormitory
Full name of responsible person
Mrs Zaeem
Street address
Abshar alley, Valiasr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Somayeh Esmaeli
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, Shahid Beheshti 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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pantea Shirooye
Position
Traditional medicine PHD student
Other areas of specialty/work
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
+98 88795008
Email
http://traditional.sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pantea Shirooye
Position
Traditional medicine PHD student
Other areas of specialty/work
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
http://traditional.sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pantea Shirooye
Position
Traditional medicine PHD student
Other areas of specialty/work
Street address
Shams Alley, Vali-e Asr Ave, Tehran, Iran
City
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)