The aim of this study is to evaluate the treatment efficacy of different treatment modalities in primary dysmenorehoea. This study was conducted in Hamadan on female students of Hamadan University of Medical Sciences during 1388-1389 educational years. Female student with primary dysmenorreha were included in the study and the exclusion criteria were: 1-Any systemic disease such as liver, kidney, thyroid and coagulation disease; 2- Hypersensitivity to drug; 3-Use of analgesic drugs during the study; 4-Use of OCP or IUD. Study participants will be divided in 4 groups. Group 1 will receive Fenellin, 30 drops every 4 hours beginning one day before the start of the cycle until the third day; Group 2 will receive Vitagnus 40 once a day in the morning beginning one day before the start of the cycle until the third day; Group 3 will receive Mefenamic acid 250 mg capsules every 4 hours beginning one day before the start of the cycle until the third day; Group 4 will receive Placebo, 30 drops every 4 hours beginning one day before the start of the cycle until the third day. Pain intensity and the severity of menstrual bleeding will be measured and compared by means of visual analogue scale and Higam methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810303109N1
Registration date:2010-06-12, 1389/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-12, 1389/03/22
Registrant information
Name
Fatemeh Zeraati
Name of organization / entity
Hamadan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6295
Email address
zeraati@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan Medical University
Expected recruitment start date
2010-01-12, 1388/10/22
Expected recruitment end date
2011-01-12, 1389/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of herbal extrats (Fenellin & Vitagnus) and Mefenamic acid in the treatment of primary dysmenorrhea and menstrual bleeding
Public title
Effect of herbal extracts in primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Female student with primary dysmenorreha
Exclusion criteria:
1-Any systemic disease such as liver, kidney, thyroid and coagulation disease
2- Hypersensitivity to drug
3- Use of analgesic drugs during the study
4- Use of OCP or IUD
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Research Ethics committee of Hamadan University of Medical Sciences
Street address
Deputy dean of Research, Medical School, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
empty
Ethics committee reference number
13681017
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
Pain
Timepoint
The day before the menstrual cycle starts and day 1, 2, and 3 of the cycle in three successive cycles
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Menstrual bleeding
Timepoint
Day 1, 2, and 3 of the menstrual cycle in three successive cycles
Method of measurement
Using Higam method
Intervention groups
1
Description
Group 1 will receive Fenellin, 30 drops every 4 hours beginning one day before the start of the cycle until the third day
Category
empty
2
Description
Group 4 will receive Placebo, 30 drops every 4 hours beginning one day before the start of the cycle until the third day
Category
Placebo
3
Description
Group 2 will receive Vitagnus 40 once a day in the morning beginning one day before the start of the cycle until the third day
Category
Treatment - Drugs
4
Description
Group 3 will receive Mefenamic acid 250 mg capsules every 4 hours beginning one day before the start of the cycle until the third day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical School
Full name of responsible person
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
Street address
Medical School, Deputy dean for Research
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
Fatemeh Shobeiri
Position
Ph.D. Maternal and Child Health
Other areas of specialty/work
Street address
School of Nursing & Obstetrics
City
Hamadan
Postal code
Phone
+98 81182762957
Fax
Email
fshobeiri@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
Fatemeh Zeraati
Position
Associated professor
Other areas of specialty/work
Street address
Pharmacology Department, Medical School
City
Hamadan
Postal code
Phone
+98 81182762957 ext. 206
Fax
Email
zeraati@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Zeraati
Position
Associated professor
Other areas of specialty/work
Street address
Pharmacology Department Of Medical School
City
Hamadan
Postal code
Phone
+98 81182762957 ext. 206
Fax
Email
zeraati@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)