Dysmenorrheal is the most commonly menstrual disorder. The common treatments have some complications, therefore in this study; the effect of topical application of Black Seed Oil on the treatment of dysmenorrheal will be assessed. This randomized study, triple-blind, placebo-control, that 140 sample were randomly selected divided into two groups; use Oil Black Seed and placebo. Oil Black Seed and placebo will be coded seperatly for sampler and data analyzer. The Demographic & history of menstrual data with researcher made questionnaire will be asked and pain intensity and premenstrual syndrome symptoms by standard questionnaire will be measured. Height and weight were measured by standard methods. one or two drops of oil rubbing at the Fontanel area during nights will be used from several days before menstruation to the 5 days after that menstrual periods, , this can be done at least three times. After intervention, the samples fill out again the questionnaires.The inclusion criteria consist of: being 15-45 years old; having regular menstrual cycle; severe or moderate menstrual pain; three days maximum duration of pain; at least 3 years of menarche; no medications or herbal pain relief not being; affected by depression or anxiety; not having an acute or chronic disease; not taking medicines or supplements and not having regular exercise
The exclusion criteria consist of: pregnancy; willingness to use hormonal contraceptive methods or taking any hormonal treatment; not taking the drug or not filling out the forms regularly; and unwillingness to continue the treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014033117109N1
Registration date:2015-11-29, 1394/09/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Ezat Samadipour
Name of organization / entity
Sabzevar medical university
Country
Iran (Islamic Republic of)
Phone
+98 26 42454
Email address
samadipe@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing topical application of Black Seed Oil and placebo on primary dysmenorrheal and premenstrual syndrome
Public title
Black Seed Oil effect on dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria consist of: being 15-45 years old; having regular menstrual cycle; severe or moderate menstrual pain; three days maximum duration of pain; at least 3 years of menarche; no medications or herbal pain relief not being; affected by depression or anxiety; not having an acute or chronic disease; not taking medicines or supplements and not having regular exercise
The exclusion criteria consist of: pregnancy; willingness to use hormonal contraceptive methods or taking any hormonal treatment; not taking the drug or not filling out the forms regularly; and unwillingness to continue the treatment
Age
From 18 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar, University of Medical Sciences, 5KM Tehran road
City
Sabzevar
Postal code
9613873136
Approval date
2014-02-10, 1392/11/21
Ethics committee reference number
medsab.Rec.92.30
Health conditions studied
1
Description of health condition studied
Disorder-menstural
ICD-10 code
N92
ICD-10 code description
Excessive, frequent and irregular menstruation
Primary outcomes
1
Description
pain intensity
Timepoint
pre intervention and minimal three period after intervention
Method of measurement
Prospective Record of the Impact and Severity of Menstrual Symptoms (PRISM)
2
Description
Premenstural syndrom symptoms
Timepoint
Befor intervention and after three menstural periods intervention
Method of measurement
Cox Menstrual Symptom Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The topical application Baryj Essence Pharmaceutical Company Black Seed Oil contains 30 to 40 percent oil; Linolenic Acid 55%, 2-1 drops will use on the Fontanel area for 30 seconds to two minutes with gently massage.
Finding Fontanel area: each person will open her hand completely and put her little finger on the tip of the nose and the other hand on the forehead and head along, the place of the thumb (in the middle line) is considered fontanel area. The massage will do in each period from the first day beginning of periods until 5 days after the end of period.
Category
Treatment - Drugs
2
Description
Intervention group 2: The topical application liquid vegetable Oil 2-1 drops on the Fontanel area about 30 seconds to two minutes with gently massage.
Finding Fontanel area: each person will open her hand completely and put her little finger on the tip of the nose and the other hand on the forehead and head along, the place of the thumb (in the middle line) is considered fontanel area. The massage will do in each period from several days before menstruation until 5 days after the end of period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar University of Medicine Science
Full name of responsible person
Dr Mohamad Mohamadzadeh
Street address
Vice chancellor for research, 5 KM Tehran Road, Sabzevar University of Medicine Sciences
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Sabzevar University of Medicine Sciences
Full name of responsible person
Dr Mohamad Mohamadzadeh
Street address
Vice chancellor for research, 5 KM Tehran road,Sabzevar University of Medical Sciences
City
Sabzevar
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, Sabzevar University of Medicine 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
Sabzevar University of Medicine Sciences
Full name of responsible person
Ezat Samadipour
Position
faculty member
Other areas of specialty/work
Street address
Paramedical Collegue, 5 KM Tehran road, University of Medicine, Sabzevar
City
Sabzevar
Postal code
9613873136
Phone
+98 514446070
Fax
+98 514445648
Email
samadipe@medsab.ac
Web page address
medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Akram kooshki
Position
PhD
Other areas of specialty/work
Street address
Department of Nutrition and Biochemistry, Sabzevar University of Medical Sciences, 5 KM Tehran road
City
Sabzevar
Postal code
9613873136
Phone
+98 514446070
Fax
+98 514445648
Email
akooshki.nutr@yahoo.com
Web page address
medsab.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)