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Evaluation of Mint efficacy on primary dysmenorrhea in comparison with Mefnamic Acid

Protocol summary

Summary
Objective: Determining the effect of peppermint capsule in comparison with mefenamic acid on primary dysmenorrheal. Design: Double blind crossover randomized clinical trial. Inclusion Criteria: a) Primary dysmenorrhea; b) Single; c) 18-25 years old. Exclusion criteria: a) Contraindication of mint including obstruction of common bile duct, allergy, cholecystitis, chronic liver disease, and gastroesophageal reflux, b) contraindication of mefenamic acid including: allergy, gastritis, gastric ulcer, chronic renal failure, chronic liver disease, anemia, asthma, diabetes mellitus. Sample size: 432. Interventions: Group1: Peppermint oil capsule (commercial name:colpermin) TDS for 3 days. Group 2: Mefenamic acid capsule (commercial name: Ponstan manufactured by Razak Co.) 250 mg TDS for 3 days. Control group: Placebo capsule. Outcomes: a) symptoms, b) the duration pain, c) the severity of pain, d) bleeding, e) nausea, f) vomiting, g) diarrhea.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011205206N1
Registration date: 2011-02-06, 1389/11/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-02-06, 1389/11/17
Registrant information
Name
Hurieh Rezvani asl
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
zahra.masoumi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2011-02-19, 1389/11/30
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Mint efficacy on primary dysmenorrhea in comparison with Mefnamic Acid
Public title
Effect of Mint and Mefnamic Acid on Menstrual Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: a) Primary dysmenorrhea; b) Single; c) 18-25 years old. Exclusion criteria: a) Contraindication of mint including obstruction of common bile duct, allergy, cholecystitis, chronic liver disease, and gastroesophageal reflux, b) contraindication of mefenamic acid including: allergy, gastritis, gastric ulcer, chronic renal failure, chronic liver disease, anemia, asthma, diabetes mellitus.
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 432
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
In front of Mardom Park Mahdieh St.
City
Hamadan
Postal code
518/65178
Approval date
2010-12-06, 1389/09/15
Ethics committee reference number
137435/9/35/16/پ

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
Duration of Dysmenorrhea
Timepoint
After taking
Method of measurement
Standard questionnaire (COX)

2

Description
Severity of Menstrual pain
Timepoint
After taking
Method of measurement
Standard questionnaire of pain violence(vas)

3

Description
Amount of menstrual bleeding
Timepoint
End of menstrual periods
Method of measurement
Standard questionnaire of Hylgam menstrual bleeding

4

Description
Nausea
Timepoint
End of menstrual periods
Method of measurement
Questionnaire

5

Description
Vomiting
Timepoint
End of menstrual periods
Method of measurement
Questionnaire

6

Description
Diarrhea
Timepoint
End of menstrual periods
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Side effects
Timepoint
After taking
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group1: Peppermint oil capsule (commercial name:colpermin) TDS for 3 days
Category
Treatment - Drugs

2

Description
Intervention group 2: Mefenamic acid capsule (commercial name: Ponstan) manufactured by Razak Co. 250 mg TDS for 3 days
Category
Treatment - Drugs

3

Description
Control group: Placebo capsule containing sugar
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dormitories of Hamadan University of Medical Sciences & Hamadan University
Full name of responsible person
Hurieh Rezvani asl
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Ghaleiha Ali
Street address
In front of Mardom Park Mahdieh St.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences
Full name of responsible person
Jalal Poorolajal
Position
PhD of Epidemiology
Other areas of specialty/work
Street address
Department of Epidemiology and Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1826 0661
Fax
+98 81 1825 5301
Email
poorolajal@umsha.ac.ir; poorolajal@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Hurieh Rezvani Asl
Position
Bachelor of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 912 747 4031
Fax
Email
horerezvani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Hurieh Rezvani Asl
Position
Bachelor degree Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 912 747 4031
Fax
Email
horerezvani@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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