Objective: To evaluate the analgesic effect of cimetidine and placebo in the treatment of primary dysmenorrhea Comparison with mefenamic acid
Case study: students currently studying at the University of Semnan.
Sample: Patients were randomly assigned to three groups C, B, A, up to 30 people in each group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051212701N2
Registration date:2013-06-12, 1392/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Mohammad Forozeshfard
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 2362 2990
Email address
mff@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of cimetidine versus mefnamic acid,placebo in primary dysmenorrhea in girl student in semnan town in 2012.
Public title
Cimetidine in the treatment of primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 22-18 years old; one year of regular menstrual cycle; the first three days of menstruation; menstrual complaints of pain; pain cycle so that more medication may be needed.
Exclusion criteria: lack of sufficient cooperation; BMI more than 26; history of gastrointestinal disease, such as I BS; urological disease (repetition burning urination); Endometriosis; Epilepsy; genital system disorders such as infectious disease; previous abdominal surgery; a history full term pregnancy; - a history of sensitivity to cimetidine; drugs interaction with cimetidine for example: Warfarin - phenytoin - Inderal - nifedipine. Diazepam and antidepressants - Lidocaine - theophylline - metronidazole; use of other drugs to reduce the pain of dysmenorrhea.
Age
From 18 years old to 22 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences
City
semnan
Postal code
Approval date
2012-08-07, 1391/05/17
Ethics committee reference number
5848/16/91
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Analgesia
Timepoint
For 6 months after intervention
Method of measurement
Numeric Rating Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Group B mefenamic acid capsules of 250 mg every 6 hours for 4 days of menstruation is given.
Category
Treatment - Drugs
2
Description
Group C placebo capsules for 4 days is menstruation.
Category
Treatment - Drugs
3
Description
A group of cimetidine 300 mg every 6 hours for 4 days of menstruation is given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Sanam Moradan
Street address
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Raheb Ghorbany
Street address
Semnan University of Medical Sciences
City
semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Forozeshfard Mohammad
Position
Professional MD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1444 1021
Fax
Email
mff@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Forozeshfard Mohammad
Position
Professional MD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1444 1021
Fax
Email
mff@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Forozeshfard Mohammad
Position
Professional MD
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 1444 1021
Fax
Email
mff@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)