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IRCT20161226031582N1 IRCT 2018-01-11 Ghoum University of Medical Sciences Effect of Capsella bursa-pastoris with placebo on abnormal uterine bleeding and quality of life in patients with uterine leiomyoma. Comparison of Capsella bursa-pastoris with placebo in Menometrorrhagia and quality of life in patients with uterine leiomyoma. 2017-12-22 anticipated 120 Complete https://irct.ir/trial/27773 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation of patients to the two groups is based on the block method. The size of block 4 is considered. So there are six quadruple blocks, including AABB, ABAB, BBAA, BABA, ABBA, BAAB. Selection of each block will also be a crash and will be done using dice throwing. According to the sample size of 120 and the fourth block, at least 30 blocks are required, Blinding description: This study will be conducted double-blinded.For this purpose, patients and the investigator will not be aware of the nature of prescribing drugs. For this purpose, each participant is given code at the beginning of the study. 2-3 Menometrorrhagia. Intervention 1: Intervention group: Treated with 500mg capsules containing Capsella bursa-pastoris extract and starch, they will be placed three times a day between meals at 10am, 5am and will sleep for three months before bedtime. Intervention 2: Control group:The control group will receive 500 mg ofcapsules containing starch, three times a day between meals at 10:00 am, 5 am and before bedtime for three months. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data Set: primary and secondary outcome measure only, study Protocol, informed consent form, clinical study report. When: Start the access period 6 months after printing the results. To whom: For researchers working in academic and scientific institutions. Conditions: For academic use and sent by academic mail. Where to obtain: Contact me by email. How to obtain: To the request sent to me by academic mail,the documentation will be emailed as soon as possible. Comments:
public Atiehsadat Danesh
Saheli Street,School of Persian medicine
Qom Iran (Islamic Republic of) 3719657189 +98 25 3770 7843 atiehsdanesh@gmail.com Ghoum University of Medical Sciences scientific Dr Fatemeh Nojavan
Saheli Street,School of Persian medicine
Qom Iran (Islamic Republic of) 3719657189 +98 25 3770 7843 Mapn2001@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 50 years Female 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 N92.0 Excessive and frequent menstruation with regular cycle Treatment - Drugs Placebo Intervention group: Treated with 500mg capsules containing Capsella bursa-pastoris extract and starch, they will be placed three times a day between meals at 10am, 5am and will sleep for three months before bedtime. Control group:The control group will receive 500 mg ofcapsules containing starch, three times a day between meals at 10:00 am, 5 am and before bedtime for three months. 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. 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. Ghoum University of Medical Sciences Approved 2017-10-31 Ethics Committee in Biomedical Research of Qom University of Medical Sciences Plaque 83, 4th Alley, 1/1 Lane, Safashar Street Qom Ghoum Iran (Islamic Republic of)