Dysmenorrhea has high incidence which can influence the daily activities. The aim of this study was to compare the effect of mefenamic acid and matricaria camomilla capsules on primary dysmenorrhea. This triple-blind randomized clinical trial study was performed on 90 students with primary dysmenorrhea, staying in Kashan medical University dormitory. They were divided into two groups of 45 individuals who received 250 mg of camomilla and 250mg mefenamic acid per 8 hourse. Treatment was started 48h before the beginning of menstruation and continued until the 24h of bleeding until 2 cycle. Severity of pain was monitored by visual analogous scale method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070410160N2
Registration date:2012-08-07, 1391/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-07, 1391/05/17
Registrant information
Name
Zahra Karimian
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
karimian-za@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences and Barije Essence company
Expected recruitment start date
2011-06-02, 1390/03/12
Expected recruitment end date
2012-09-02, 1391/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of camomilla and mefenamic acid on dysmenorrhea
Public title
Comparing the effect of camomilla and mefenamic acid on dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 – having moderate or severe dysmenorrhea; 2 - not having a drug history; 3 – not having certain medical conditions; 4 – having regular cycles. Exclusion criteria: 1 - Being Married; 2 - Mild dysmenorrhea; 3 - History of a drug taking or diseases; 4 - History of taking OCP.
Age
From 18 years old to 29 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Kashan University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Ravand blvd
City
Kashan
Postal code
03615550021
Approval date
2008-09-13, 1387/06/23
Ethics committee reference number
8763
Health conditions studied
1
Description of health condition studied
Menstural pain
ICD-10 code
N94.6
ICD-10 code description
Dysmenorrhoea, unspecified
Primary outcomes
1
Description
Dysmenorrhea
Timepoint
cycle 1 and 2 after treetment
Method of measurement
visal analogus scale
Secondary outcomes
1
Description
Menstural pain
Timepoint
Cycles 1 and 2
Method of measurement
MQ gill pain scale
Intervention groups
1
Description
Control group: received 250 mg of mefenamic acid. Treatment was started 48h before the beginning of menstruation and continued until the 24h of bleeding until 2 cycles.
Category
Treatment - Drugs
2
Description
Intervention group: received 250 mg of camomilla. Treatment was started 48h before the beginning of menstruation and continued until the 24h of bleeding until 2 cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan dormitory
Full name of responsible person
Zahra Krimian
Street address
Faculty of Nursing and Midwifery, Kashan University of Medical Sciences
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidi Gholamali
Street address
Faculty of Nursing and Midwifery, Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Barij Esanse company
Full name of responsible person
Dr Reza Bekhradi
Street address
Ardehal mashhad
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Esanse company
Proportion provided by this source
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
Kashan University of Medical Sciences
Full name of responsible person
Karimian Zahra
Position
MsC of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 7783
Fax
Email
karimian62@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Karimian Zahra
Position
MsC of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 7783
Fax
Email
karimian62@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Karimian Zahra
Position
MsC of midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Kashan University of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
karimian62@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)