Comparing the effect of hydroalchoholic extract of Urtica Dioica with mefenamic acid on Menorrhagia in referring women to gynecological centeres related to Mazandaran Medical Sience university on 2011.
This study will be done in triple blind method with the target of determining the effect of urtica dioica on menorrhagia. Inclusion criteria are: Age 15 to 45 years; Body Mass Index 18.5 to 29.9; having regular menstrual periods; Being affected by menorrhagia; distinguished by using pictorial blood loss assessment chart and exclusion criteria are: allergy to urtica dioica; Having an special disease; pregnancy or deciding to be pregnant in three future month; berest feeding; dont follow the exact priscribed curing method and patient,s tendency to going out of study. the comunity of study includes all of the women affected by menorrhagia which refer to gynecological centeres related to medical science university of Mazandaran in 2011. 90 patients will be allocated into two groups by chance, control group or intervention group and then mefenamic acid and urtica dioica will be prescribed to intervention group and mefenamic acid and placebo of urtica dioica will be prescribed to control group for two cycle. the number of days and amount of bleeding will be checked inside and between groups before intervention and after the first and second cycle of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111254529N3
Registration date:2012-05-17, 1391/02/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-17, 1391/02/28
Registrant information
Name
Nourossadat Kariman
Name of organization / entity
Shaheed Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 3133
Email address
n_kariman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshty University Of Medical Science; International Part.
Expected recruitment start date
2012-01-05, 1390/10/15
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of hydroalchoholic extract of Urtica Dioica with mefenamic acid on Menorrhagia in referring women to gynecological centeres related to Mazandaran Medical Sience university on 2011.
Public title
Comparing the effect of Urtica Dioica with mefenamic acid on heavy menstrual bleeding.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age15 to 45 years; Body Mass Index 18.5 to 29.9; Being affected by menorrhagia, distinguished by using pictorial blood loss assessment chart. exclusion criteria: Having an special disease; pregnancy or deciding to be pregnant in three future month; berestfeeding; allergy to urtica dioica; dont follow the exact priscribed curing method; patient,s tendency to going out of study.
Age
From 15 years old to 45 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
shahid beheshti university of medical science - international part
Street address
valiasr Street-shahid abbaspur Street ( tavanir ) -hemmat bridge- 19
City
Thran
Postal code
1434875451
Approval date
2011-12-13, 1390/09/22
Ethics committee reference number
3739/116
Health conditions studied
1
Description of health condition studied
Menorrhagia
ICD-10 code
N92.0
ICD-10 code description
خونریزی شدید قاعدگی با سیکلهای منظم.
Primary outcomes
1
Description
Number of days of bleeding in menstruation.
Timepoint
Befor, one month and then two month after intervention.
Method of measurement
By using pictorial blood loss assessmant chart.
2
Description
Amount of menstrual Bleeding.
Timepoint
Befor, one month and two month after intervention
Method of measurement
By using pictorial blood loss assessmant chart.
Secondary outcomes
1
Description
side effects of priscribed drugs
Timepoint
During and after first and second month of using drugs.
Method of measurement
By using the chart of daily using of drugs.
Intervention groups
1
Description
mefenamic acid cap 500 mg q8hr and Urtica dioica cap 1 mg q12hr, from the first day of menstrustion, for 7 days will be prescribed to intervention group.
Category
Treatment - Drugs
2
Description
mefenamic acid cap 500 mg q8hr and placebo of Urtica dioica cap 1 mg q12hr, from the first day of menstrustion, for 7 days will be prescribed to placebo group.