Dysmenorrhea is the most common gynecologic complaint among adolescent and adult females. Some dysmenorrheic females do not respond to treatment with NSAIDs or oral contraceptives and exhibit contraindications to such medications. Therefore, alternative medication, gained importance in the management of dysmenorrhea. Aim of the study is comparing the effects of ginger, dill seeds and cumin on primary dysmenorrhea and menstrual symptoms in females with primary dysmenorrhea.
The study is a comparative clinical trial. It will be conducted on thirty primary dysmenorrheic subjects that have inclusion conditions for entering the study. They will be assigned randomly to three groups( 10 member in each group) . First group members will consume 1 gram of Ginger powder daily, second group and third group will consume 3 gram of Dill seed powder and Cumin powder, respectively. The powders will be prepared in capsules and the subjects will consume them for first three days of their menstruation for three successive cycles. Then menstrual pain intensity at the end of the each day will be measured by Numerical Pain Scale (NPS).As well as other symptoms will be assessed by Menstrual Distress Questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022326724N1
Registration date:2016-07-01, 1395/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Shabnam Omidvar
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 2511
Email address
sh.omidvar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Mysore, Manasagangothri-Babol University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effect of Dill seeds, Ginger and Cumin on dysmenorrhea
Public title
effect of herbs on dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Being mature; Age between 12 to 28 years; Moderate or severe menstrual pain; unmarried.
Exclusion criteria: Age below 12 or above 28 years; Being married; known allergy to cumin, ginger or dill; Those with known secondary dysmenorrhea; History of surgery in abdomen or pelvic area; Those with health problems.
Age
From 12 years old to 28 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IHEC-Univesity of Mysore
Street address
University of Mysore, Manasagangotri
City
Mysore
Postal code
570006
Approval date
2009-07-29, 1388/05/07
Ethics committee reference number
31 Ph.D/2009-10
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94
ICD-10 code description
N94.4
Primary outcomes
1
Description
pain intensity
Timepoint
before and after intervention for three successive cycles
Method of measurement
Numerical pain scale
Secondary outcomes
1
Description
Muscle stiffness
Timepoint
Before and after intervention(daily)
Method of measurement
Based on Menstrual Distress Questionnaire
2
Description
Skin disorders
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
3
Description
Dizziness
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
4
Description
Headache
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
5
Description
Cold sweat
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
6
Description
Cramps
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
7
Description
Tender breasts
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
8
Description
Nausea and Vomiting
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
9
Description
Backache
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
10
Description
Swelling(breasts, Abdomen)
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
11
Description
Hot flashes
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
12
Description
Fatigue
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
13
Description
General aches
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
14
Description
Swelling legs
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
15
Description
Numbness
Timepoint
Before and after intervention(daily)
Method of measurement
Menstrual Distress Questionnaire
Intervention groups
1
Description
Dill seed powder 3 gram per day for first three days of menstruation
Category
Treatment - Drugs
2
Description
Cumin powder, 3 gram per day for first three days of menstruation
Category
Treatment - Drugs
3
Description
Ginger powder 1 gram per day for first three days of menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Mysore
Full name of responsible person
Dr. Khyrunnisa Begum
Street address
DOS in Food science and Nutrition, University of Mysore
City
Mysore
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Mysore, Manasagangothri
Full name of responsible person
Khyrunnisa Begum
Street address
DOS in Food Science and Nutrition
City
Mysore
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Mysore, Manasagangothri
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
Shabnam Omidvar
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Medical Department, Babol University of Medical Sciences
City
Babol
Postal code
47176-47745
Phone
+98 11 4422 2511
Fax
Email
shomidvar@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
Shabnam Omidvar
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Medical Department, Babol University of Medical Sciences , Ganjafrooz St
City
Babol
Postal code
47176-47745
Phone
+98 11 4422 2511
Fax
Email
shomidvar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shabnam Omidvar
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Babol University of Medical Sciences
City
Babol
Postal code
47176-47745
Phone
+98 11 4422 2511
Fax
Email
shomidvar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)