Effect of Capsella bursa-pastoris with placebo on abnormal uterine bleeding and quality of life in patients with uterine leiomyoma.

Phase 2

Conditions: Menometrorrhagia.
Excessive and frequent menstruation with regular cycle
N92.0

Registration Number: IRCT20161226031582N1

Lead Sponsor: Ghoum University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 120

Inclusion Criteria

Having a score more than 100 in Pictorial blood assessment chart
Age between 18 to 50 years old
The existence of uterine leiomyoma proven in ultrasound
No use of any effective medication on menstrual bleeding such as: 0CP, ASA, anti-coagulant
No regular use of special herbal remedy during the 2 weeks before the study
No systemic disease such as :Thyroid, Hyperprolactinemia, Coagulopathy, hemoglobinopathy
No abnormal pap smear
No pregnancy
No breast feeding

Exclusion Criteria

Incidence of surgical indications such as: abnormal bleeding disorder of vital signs, resistant anemia to usual treatments, severe anemia (hemoglobin below 7), acute pain, severe urinary symptoms or hydronephrosis
The use of any hormone, anti-fibrinolytic or systemic glucocorticoid
The use of Monoamine oxidase inhibitors
allergy to the drug studied
Pregnancy during the study
Unwilling to continue participation in the study
Incidence of side-effects requiring special treatment

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of Menstrual bleeding. Timepoint: One month before, first, second and third month after intervention. Method of measurement: Higam Chart.;Duration of Menstrual bleeding. Timepoint: One month before, first, second and third month after intervention. Method of measurement: Calendar.;Quality of life. Timepoint: Before and 3 months after intervention. Method of measurement: Menorrhagia questionnaire.

Secondary Outcome Measures

Name	Time	Method
Size of uterine leiomyoma. Timepoint: Before and 3 months after intervention. Method of measurement: Ultrasound.;Side effects of medication. Timepoint: 3 months after intervention. Method of measurement: Questionnaire.