Comparison the effect of Trachyspermum ammi with mefenamic acid on primary dysmenorrhea: A randomized clinical trial
Design
Patients are randomly assigned to two equal groups according to a random number table. One group will be treated with mefenamic acid and another with trachyspermum ammi capsuls. The sample size is 70, which consists of two groups of 35 people. This trial is phase 3.
Settings and conduct
After study confirmation and obtaining ethics code from the Medical Ethics Committee of IUMS and registration in IRCT, study will be started by installing a recall in the student dormitory of the TUMS. For patients who have inclusion criteria study will be explained and the consent form will be completed by them.The individual information questionnaire will be completed.The pain level will be determined based on the VAS. Duration of pain will also be checked. Also, patients will be divided into moderate and severe dysmenorrhea groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1.Moderate to severe dysmenorrhea based on the Verbal Multidimentional Scoring System.
2. Rejection of the secondary dysmenorrhea
3. Regular cycles
Exclusion criteria:
1 history of abdominal or pelvic surgery
2 taking anticoagulant drugs
3 trachyspermum ammi allergy history
4 history of hemorrhagic diseases
5 Pregnancy and breastfeeding
6 trachyspermum ammi allergy occurance during the Study
7 incorrect drug consumption
8 mefenamic acid side effect history
9 Demyelinating inflammatory diseases
10 patients with severe side effects.
11 Patients requiring other interventions.
12 patients who are reluctant to continue studying.
Intervention groups
35 patients who receive trachyspermum ammi capsules
Main outcome variables
Changes in pain duration and intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180805040697N1
Registration date:2019-04-01, 1398/01/12
Registration timing:retrospective
Last update:2019-04-01, 1398/01/12
Update count:0
Registration date
2019-04-01, 1398/01/12
Registrant information
Name
Fateme Zali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3272 2060
Email address
zali.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Trachyspermum ammi with mefenamic acid on primary dysmenorrhea: A randomized clinical trial
Public title
Comparison the effect of Trachyspermum ammi with mefenamic acid on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
modorate to severe dysmenorrhea according to Verbal Multidimentional Scoring System
exclude secondry dysmenorrhea by history taking and confirmation of primary dysmenorrhea diagnosis
Regular cycles with a maximum of 3 to 4 days of priority or delay
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization based on random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Science.
Street address
next to Milad Tower, Hemat highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-09-27, 1397/07/05
Ethics committee reference number
IR.IUMS.REC1397056
Health conditions studied
1
Description of health condition studied
Primary Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
primary Dysmenorrhoea
Timepoint
The day before menstruation and the first three days of menstruation in three consecutive cycles
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving 500 mg capsules containing seeds powder TDS, from 4 days before mensturation until the third day
Category
Treatment - Drugs
2
Description
Control group: Receiving Mefenamic acid capsules, the first dose 500 mg and then 250 mg every 8 hours if necessary
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls Dormitory of Tehran University of Medical Sciences
Full name of responsible person
fatemeh zali
Street address
Girls Dormitory of Tehran University of Medical Sciences, north Kargar street
City
Tehran
Province
Tehran
Postal code
1417733161
Phone
+98 21 8895 4926
Email
fatemehzali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
..
Street address
Tehran Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Zali
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Behesht St. Vahdat Islami St
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
fatemehzali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Zali
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Behesht St. Vahdat Islami St
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
fatemehzali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Zali
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Behesht St. Vahdat Islami St
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5563 9667
Email
Fatemehzali@yahoo.com
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