Study of the effect of Trachyspermum ammi (L.) ( Ajowan ) and Apium graveolens L. (Wild Celery) on dysmenorrhea compared to mefenamic acid
Design
clinical trial with a parallel group, triple blinded, randomised
Settings and conduct
The present study was conducted on 81 single girl students living in a dormitory in Yazd University of Medical Sciences in 2018. The data collection method was a questionnaire. Using the visual analog scale, the severity of the patient's pain was ranged from very severe to mild.The severity of pain was evaluated using a visual analog scale (VAS) from zero to 10 degrees.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age between 19 to 31 years
the single person living in a dormitory
No specific disease history
has no history of taking oral contraceptive pills or herbal drug allergy
Exclusion criteria:
Patients with chronic diseases (diabetes, hypertension, kidney disease, etc.)
if take oral contraceptives during the research
Surgical history in the genital area
Report any allergies to plants
Intervention groups
After receiving the code of ethics and obtaining the necessary permissions from the University's Ethics Committee, according to entry and exit criteria, individuals were randomly divided into four groups.
The intervention group 1 consists of people with primary dysmenorrhea who receive the Trachyspermum ammi (Ajowan)
The intervention group 2 consists of people with primary dysmenorrhea who receive the Apium graveolens (celery)
The intervention group 3 consists of people with primary dysmenorrhea who receive the Trachyspermum ammi (Ajowan) and Apium graveolens (celery)
The intervention group 4 consists of people with primary dysmenorrhea who receive the Mefenamic acid
Main outcome variables
Intensity of pain
Rate of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027729N3
Registration date:2019-06-28, 1398/04/07
Registration timing:registered_while_recruiting
Last update:2019-06-28, 1398/04/07
Update count:0
Registration date
2019-06-28, 1398/04/07
Registrant information
Name
Moneyreh Modares Mosadegh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
modares@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-18, 1397/02/28
Expected recruitment end date
2019-07-18, 1398/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Trachyspermum ammi (L.) ( Ajowan ) and Apium graveolens L. (Wild Celery) on dysmenorrhea compared to mefenamic acid
Public title
Effect of Celery seeds and Ajowan seeds on menstrual pain versus Mefenamic acid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 19 to 31 years
the single person living in a dormitory
No specific disease history
has no history of taking oral contraceptive pills or herbal drug allergy
Exclusion criteria:
Patients with chronic diseases (diabetes, hypertension, kidney disease, etc.)
if take oral contraceptives during the research
Surgical history in the genital area
Report any allergies to plants
Age
From 19 years old to 31 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: Simple randomization
Unit of randomization: individual
using random numbers table
Allocation concealment: Sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Triple blinded
Blinding description
participants, main investigator, outcome assessor and data safety monitoring board will be blind in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Alem square
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2018-05-18, 1397/02/28
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.152
Health conditions studied
1
Description of health condition studied
Primary dysmenrrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before starting treatment, one month and two months after starting treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
intensity of pain
Timepoint
Before starting treatment, one month and two months after starting treatment
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group:Patients in a group of Trachyspermum ammi will use 50 mg of a Trachyspermum ammi every 8 hours, from 24 hours before to 48 hours after menstruation
Category
Treatment - Drugs
2
Description
Intervention group: Patients in the Apium graveolens group will use 50 mg of a celery every 8 hours, from 24 hours before to 48 hours after menstruation
Category
Treatment - Drugs
3
Description
Intervention group:Patients in the Trachyspermum ammi- Apium graveolens group will use 50 mg of a Trachyspermum ammi and 50 mg of celery every 8 hours, from 24 hours before to 48 hours after menstruation
Category
Treatment - Drugs
4
Description
Intervention group: Patients in the Mefenamic Acid Group will take one capsule (250 mg) every 8 hours, from 24 hours before to 48 hours after menstruation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory and Sports Hall of Yazd University of Medical Sciences
Full name of responsible person
Mohadeseh Barzin
Street address
Imam Hussein and Bahonar and Alam Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
modares@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Mehrparvar
Street address
Third floor, Centeral Building, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2136
Email
ah.mehrparvar@gmail.com
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 and Technology of Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Moneyreh Modares Mosadegh
Position
Faculty of Dept. of Pharmacology/ Pharm.D.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
modares@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Moneyreh Modares Mosadegh
Position
Faculty of Dept. of Pharmacology/ Pharm.D.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
modares@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Moneyreh Modares Mosadeg
Position
Faculty of Dept. of Pharmacology/ Pharm.D.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem Square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
modares@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available