In previous studies, extract of 3 herbs, celery, fenugreek and saffron is effective on primary dysmenorrhea. However, the health effects of saffron alone on primary dysmenorrhea have not been yet studied. The aim of this study is to examine the effects of saffron on primary dysmenorrhea and comparison with the effectiveness of Mefenamic Acid in women aged 18-27 years old that will be conducted as double blind single center study.
At first, Patients are identified by questionnaire and diagnostic questions. Then patients with primary dysmenorrhea divided into three groups. Group 1 receive saffron capsule three times per day for three days of menstrual period for three consecutive menstural cycles. Group 2 receive mefenamic acid, and group 3 receive identical placebo with the same protocol as group one.
Visual Analogue Scale (VAS) and Verbal Multidimensional Scoring system (VMS) will be completed and recorded at baseline and after each menstrual period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081329327N1
Registration date:2016-12-16, 1395/09/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-16, 1395/09/26
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2017-03-01, 1395/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Crocus Sativus and Mefenamic Acid on primary Dysmenorrhea in young adult female students
Public title
Comparison of the effects of saffron and Mefenamic Acid on Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:primary dysmenorrhea; Not having asthma, GI problems, intolerance to NSAIDs; Age = 18-27 years; written informed consent.
Exclusion criteria:pregnancy; allergy to herbal products including saffron
Age
From 18 years old to 27 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Based on block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Pharmaceutical Sciences
Street address
Yakhchal Ave., Shariati st., Tehran
City
Tehran
Postal code
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
IR.IAU.PS.REC.1395.8
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
Pain
Timepoint
3rd day of menstural cycle
Method of measurement
Visual Analogue Scale (VAS) and Verbal Multidimensional Scoring system (VMS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: will receive handmade saffron capsule, 30 mg dried saffron powder, three times per day for three days of menstrual period for three consecutive menstural cycles.
Category
Treatment - Drugs
2
Description
Intervention group 2: will receive mefenamic acid 250mg capsule (Amin Pharmaceuticals, Isfahan, Iran) three times per day for three days of menstrual period for three consecutive menstural cycles.
Category
Treatment - Drugs
3
Description
Control group: will receive placebo capsule three times per day for three days of menstrual period for three consecutive menstural cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Parastoo Azimi
Street address
Yakhchal Ave., Shariati st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
No sponsor used
Full name of responsible person
none
Street address
none
City
none
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
No sponsor used
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
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Other areas of specialty/work
Street address
#99, Yakhchal Ave, Shariati st.
City
Tehran
Postal code
Phone
+98 21 6393 5258
Fax
Email
r_abrishami@iaups.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Other areas of specialty/work
Street address
#99, Yakhchal Ave, Shariati st.
City
Tehran
Postal code
Phone
+98 21 6393 5258
Fax
Email
r_abrishami@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Pharmaceutical Sciences
Full name of responsible person
Ramin Abrishami
Position
Assistant Professor
Other areas of specialty/work
Street address
#99, Yakhchal Ave., Shariati St., Tehran
City
Tehran
Postal code
Phone
+98 21 6393 5258
Fax
Email
r_abrishami@iaups.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)