This study aimed to compare the effects of Nigella sativa with mefenamic acid randomized, double-blind will be the main criteria for inclusion aged between 30-18 years, female students are being educated and having regular menstrual periods, having dysmenorrhea the initial degree of moderate to severe based on a visual scale, the main criteria Exclusion history of abdominal surgery or pelvic, an ultrasound abnormal uterine or pelvic, obesity (BMI greater than 30) that the 70 students living in dormitories of Tehran University of Medical Sciences, Mashhad with random assignment of subjects assigned to one of two groups. To measure pain intensity on a visual scale, form the sample run is that the lines are long mm100 (cm10) drawn by zero is specified on the line as there is no pain and 100 as pain it is very intense.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040117111N1
Registration date:2015-01-26, 1393/11/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-26, 1393/11/06
Registrant information
Name
Fatemeh Mohanazadeh flaheieh
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
mohanazadehf911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the influence nigella sativa with mefenamic acid on primary dysmenorrhea
Public title
Comparison of the influence nigella sativa with mefenamic acid on primary dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age range between 30-18 years of being single and female students studying in Iran Mashhad university dormitories having regular menstrual periods of moderate to severe primary dysmenorrhea grade based on a visual scale Exclusion criteria: history abdominal or pelvic surgery, history of sexual problems of mishaps during study coagulation disorders or abnormal uterine pelvic ultrasound consumption hormonal drugs (eg contraception), NSAIDs, opioids or any ban the sensitivity to drugs obesity (BMI greater than 30)
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Mashhad University of Medical Sciences
Street address
doctora Intersection Ibn Sina Street
City
mashhad
Postal code
Approval date
2014-11-01, 1393/08/10
Ethics committee reference number
930413
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Intensity and duration of menstrual pain
Timepoint
1) two cycles before the intervention, 2) the first and second cycles of the intervention
Method of measurement
Visual analog scale and the scale Cox
Secondary outcomes
empty
Intervention groups
1
Description
one intervention group: consumption of oral nigella sativa 3 grams daily (two capsules of 500 mg every 8 hours) during the first three days of menstruation
Category
Treatment - Drugs
2
Description
Two intervention groups: consumption Mefenamic Acid 250 mg (two 500 mg capsules with 125 milligrams of active ingredient Mefenamic acid every 8 hours during the first three days of menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Residences Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Jafarnejad
Street address
Doctora intersection. Ibn Sina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodiy
Street address
University Avenue. Central Organization of Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?