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IRCT2013120715703N1 IRCT 2014-02-12 School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh Evaluation of effects of Persian Gulnar on bleeding in patients with leiomyoma of uterus Evaluation of effects of Punica granatum L.(Persian Gulnar) on bleeding in patients with leiomyoma of uterus (in Iranian Traditional Medicine) 2014-02-20 anticipated 10 Complete https://irct.ir/trial/14894 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Gulnar syrup is made from the aqueous extract of Persian Gulnar. 2 Leiomyoma of uterus. Intervention 1: Medication administration to patient (Persian Gulnar syrup, 5 cc three times a day) in menstrual cycle. Intervention time: Three months (each month 7 days). Intervention 2: Placebo administration to patients in menstrual cycle. ( 5 cc three times a day) Intervention Time: Two months (each month 7 days).
public Hajar Memarzadeh zavareh
No.8 Shams Alley, Opposite Street Tavanir, Vali Asr Street, Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 21887735212 hajarmemarzadeh@sbmu.ac.ir hajarmemarzadeh@gmail.com hajarmemarzadeh@yahoo.com School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh scientific Mojgan Tansaz M.D
Contact details : No.8 Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
Tehran Iran (Islamic Republic of) 1516745811 +98 218877352122 Tansaz@sbmu.ac.ir, Tansaz_mojgan@yahoo.com School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh Iran (Islamic Republic of) Inclusion criteria: 1) Age: 18-50 years 2) Ultrasound evidence of uterine leiomyoma (submucosal leiomyoma, intramural leiomyoma, subserosal leiomyoma). 3) History of abnormal menstrual bleeding based on the patient's complaint. Exclusion Criteria 1) Indication of uterine surgery (except Caesarean section or cervical conization). 2) Patients receiving progesterone, acetyl salicylic acid anticoagulant. 3) Patients with a positive pregnancy test. 4) History of allergy to Persian Gulnar. 5) Known hemoglobinopathies. 6) Known severe coagulation disorder. 7) Patients receiving Anti-fibrinolytic. 8) Hemoglobin below 9.5. 9) Ultrasound evidence of hyperplasia of the endometrium. 18 years 50 years Female D25 Leiomyoma of uterus Treatment - Drugs Placebo Medication administration to patient (Persian Gulnar syrup, 5 cc three times a day) in menstrual cycle. Intervention time: Three months (each month 7 days). Placebo administration to patients in menstrual cycle. ( 5 cc three times a day) Intervention Time: Two months (each month 7 days). Menstrual blood volume. Timepoint: Before the intervention, weeks 5, 9, 13 after intervention. Method of measurement: Pictorial Blood Loss assessment Chart (PBAC). Quality of life that is evaluated by Menorrhagia Questionnaire (MQ). Timepoint: Before the intervention, weeks 13 after intervention. Method of measurement: Quality of life that is evaluated by Menorrhagia Questionnaire (MQ). The size of leiomyoma. Timepoint: Before the intervention, weeks 13 after intervention. Method of measurement: ultrasound. Side effects. Timepoint: weeks 5, 9, 13 after intervention. Method of measurement: Questionnaire. School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh Approved 2013-12-04 Velenjak St., Shahid Chamran Highway, Shahid Beheshti university of Medical Sciences. Velenjak St., Shahid Chamran Highway, Shahid Beheshti university of Medical Sciences. Tehran Iran (Islamic Republic of)