Investigation the effects of hydro alcoholic extract capsule of Achillea Millefolium on the Menorrhagia of women referred to the health center of Tehran University of medical science in 2015
The aim of this study is to specify the effect of hydro alcoholic extract capsule of Achillea Millefolium on the Menorrhaiga of the women referred to the health center of Tehran University of medical science. The study conducted in 2015 and it was based on the triple blind randomized controlled clinical trial. In this clinical trial, 126 women with complaint of menorrhagia were selected. Inclusion criteria: body mass index between 18.5-29.9; affected by menorrhagia; age between 18-45 years old; no history of known systemic or pelvic inflammatory diseases; no pregnancy; no consumption of specific medications; no abnormal pap smear or ultrasonography; no history of sensitivity to medicinal plants. Exclusion criteria: sensitivity to the study medications; failure to adhere to prescribed treatment; unwilling to continue participation in the study; tacking any herbal or chemical drug during the study.
Women categorized into the control and intervention groups. Both groups consumed 500 mg Mefenamic acid capsule every 8 hours, from the first day to the end of bleeding, for two consecutive cycles. The intervention group consumed one Achillea Millefolium capsule every 8 hours. However, the controlled groups consumed placebo instead of Achillea Millefolium capsule.
Data on the amount and duration of bleeding (using Higam chart) were checked and compared before, duration and after treatment using SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041627417N1
Registration date:2016-05-03, 1395/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-03, 1395/02/14
Registrant information
Name
Farzaneh Ebrahimi Varzaneh
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
f.ebrahimi69@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effects of hydro alcoholic extract capsule of Achillea Millefolium on the Menorrhagia of women referred to the health center of Tehran University of medical science in 2015
Public title
The effects of Achillea Millefolium on the heavy menstrual bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Body mass index between 18.5-29.9; affected by menorrhagia; age between 18-45 years old; no history of known systemic or pelvic inflammatory diseases; no pregnancy; no consumption of specific medications; no abnormal pap smear or ultrasonography; no history of sensitivity to medicinal plants. Exclusion criteria: sensitivity to the study medications; failure to adhere to prescribed treatment; unwilling to continue participation in the study; tacking any herbal or chemical drug during the study.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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 Shahid Beheshti of University of Medical Sciences
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Amount of bleeding
Timepoint
Before treatment, first month during treatment, second month during treatment and one month after the end of treatment
Method of measurement
Higam Chart
Secondary outcomes
1
Description
Duration of bleeding
Timepoint
Before treatment, first month during treatment, second month during treatment and one month after the end of treatment
Method of measurement
Higam Chart
Intervention groups
1
Description
In intervention group, Mefenamic acid capsules, 500 mg every 8 hours and hydro alcoholic extract of Achillea Millefolium capsules, 150 mg per day, every 8 hours,were prescribed, from the first day to the end of bleeding.
Category
Treatment - Drugs
2
Description
In control group, Mefenamic acid capsule 500 mg every 8 hours and placebo capsules 150 mg per day, every 8 hours, were prescribed from the first day to the end of bleeding.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers affliated to Tehran University of medical science
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Shahid Beheshti University of Medical Sciences