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IRCT20181001041191N1 IRCT 2019-02-22 Mazandaran University of Medical Sciences Effect of plantago major in menstrual bleeding in patients with uterine leiomyoma اثر بارهنگ بر خونریزی قاعدگی Effectiveness of suppository plantago leaf extract on quantity of menstural bleeding in patients with uterine leiomyoma 2018-11-06 anticipated 60 Complete https://irct.ir/trial/34426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients referring to women's clinic that are based on examinations criteria They will be admitted to the study and the diagnosis of their uterine leiomyoma will be included in the study. 60 samples will be assigned by blocking method to two groups. The sample allocation method will be performed using the software, and the samples will be assigned in four blocks, Random numbers are for blocks through the software. Patients will be placed in two groups A and B using the Randomization Block. Group A is given drug and given to Group B placebo, Blinding description: For double - blind blonding, medications are prepared in special envelops with the installation of two - digit codes until the final evaluator who is a gynecologist is not aware of the type of medication received. also, for lack of information to the patient The drug received by preparing a placebo in Sari Pharmacy School that It looks be looks like a plantago major suppository that for the control group will be considered and the patients will not be aware of the type of drug they receive. 3 Submucous leiomyoma of uterus. Intervention 1: Intervention group: A total of 30 patients were treated with vaginal suppository of plantago leaf extract in two consecutive months during the first three days of menstruation. Intervention 2: Control group: 30 patients with hemorrhagic fibroma receiving the suppository containing all the components of the intervention group formulation, except for plantago leaf extract. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Syedeh Sedigheh Yousefi
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 s.yousefi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Syedeh Sedigheh Yousefi
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
Sari Iran (Islamic Republic of) 48168-95475 +98 11 3324 4893 s.yousefi@mazums.ac.i Mazandaran University of Medical Sciences Iran (Islamic Republic of) Having an age 18- 50 BMI 18/5- 29/9 Regular menstrual cycle Being married submucosal leiomyoma in ultrasonography with menstrual bleeding Unwillingness Or contraindication to taking hormone 18 years 50 years Female Surgical indication Unusal bleeding Anemia resistant to usual treatments Dysmenorrhea or severe dyspnea Acute pain Symptoms of severe urination or hydronephrosis Fast increase in mass size Start of tumor growth after menopause Patients with gastrointestinal complications Patients treated with progesterone Patients treated with acetylsalicylic acid Patient treated with anti - coagulan Patient treated with tranexamic Acid AND Ocp Taking miphe priston ' aganists NSAID' Gnrh Woman have positive pregnancy test Known hemoglobinopathy Known severe coagulation disease anti-fibrinolytic or systemic glucocorticoids Hb under 9/5 Pap smear due to displasticity disorders Having IUD D25.0 Submucous leiomyoma of uterus Treatment - Drugs Placebo Intervention group: A total of 30 patients were treated with vaginal suppository of plantago leaf extract in two consecutive months during the first three days of menstruation Control group: 30 patients with hemorrhagic fibroma receiving the suppository containing all the components of the intervention group formulation, except for plantago leaf extract. Volume of bleeding menstruation. Timepoint: The first three days of menstruation in two consecutive months. Method of measurement: Standard Bleeding Reporting Form PBAC. Blood volum. Timepoint: The first three days of the menstrual cycle. Method of measurement: PBAC questionnaire. Mazandaran University of Medical Sciences Approved 2018-07-03 Ethics committee of Mazandaran University of Medical Sciences Deputy of Research and Technology of Mazandaran University of Medical Sciences, Teacher Street, Teacher's Square Sari Mazandaran Iran (Islamic Republic of)