]>
IRCT20180622040186N1 IRCT 2018-06-26 Tehran University of Medical Sciences The effect of Golnar Capsule (Punica Grantum) in treatment of Abnormal Uterine Bleeding Evaluation of a Capsule of Golnar in Dysfunctional Uterine Bleeding and Comparison with Tranexamic acid 2018-07-06 anticipated 80 Complete https://irct.ir/trial/32084 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of patients to study groups is done using random block method. Samples were randomly divided into two intervention and control groups based on the random sequence generated by the statistic counselor, Blinding description: The tested drug (Gelnar product) and the control drug (Transxamic Acid) are identical in terms of appearance and packaging, only through the proprietary A and B codes assigned by a person outside the research group on the box of medication labels are differentiated. The patient and pharmacist prescribing expert are not aware of the concept of codes. Study outcomes of the study are also known by the researcher who are unaware of the grouping and are blind to the groups and type of medication. During each cycle, the herbal drug is used from the first day of the cycle to the end of the cycle (ie, the patient takes the drug for 3 consecutive months). But the control drug is only used from the beginning of the cycle for 5 days per cycle. For blinding in each group, each patient receives two packets of medicine with codes A1, A2 or B1 and B2. A1 and B1 codes are used from the first day of the cycle for up to 5 days, and codes A2 and B2 are used from the sixth Day cycle to the end of the cycle. In the Gelnar Group, all of 1 and 2 are medicines and in the control group, the numbers of 1 are 1 tranexamic acid and the 2nds are placebo. 3 DUB. Intervention 1: Intervention group: Persian medicine capsule based on Persian Golnar 500 mg every 8 hours, from the beginning of the menstrual period to the end of the cycle. Intervention 2: Control group: Tranexamic Acid Capsule, 500 mg every 8 hours from the first day of menstruation for up to 5 days. Yes - There is a plan to make this available What will be shared: Expression of the procedure and drug used and treatment results When: Six months after completing the results analysis To whom: Data will be available to researchers working in academic and academic institutions Conditions: Analysis on the data with the permission of the investigating officer is preventable. Where to obtain: E-mail, Dr. Somayeh Eshaghee Ashtiany How to obtain: Six months after data analysis Comments:
public Somayeh Es.haghee Ashtiany
No 28; Zahra Ave; Niroo Daryaee Ave; Resalat Squ
Tehran Iran (Islamic Republic of) 1676996913 +98 21 7719 1254 s-eshaghee@razi.tums.ac.ir Tehran University of Medical Sciences scientific Dr Marzieh Vahid Dastjerdi
Office of Hospital Head, Arash Hospital, Next to Police Station 126, Baghdarnia St.; South Rashid St.; The Second Square of Tehranpars,Tehran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3283 mdastgerdi@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women from 18 years old to 50 years old Normal Pap smear Regular Menstruation Bleeding Endometrial thickness is less than 10 mm Severe Menstruation (According to PBAC: Score>100, 80 cc) or Prolonged Menstruation (More than 7 Days ) Normal Gynecological Examination 18 years 50 years Female Pregnancy, Plan to become pregnant in the next three months Coagulation Disorders, Systemic Diseases such as Hepatic, Renal, Thyroid, Diabetes and Chronic Inflamatory diseases FSH And LH Disorders Hemoglobin less than 10 Endometrial Disorder, Hyperplasy, Cervical, Uterine and Ovary Cancers Leiomyom and subcutaneous or internal fibroids greater than 4 cm Endometriosis Known Hemoglobinopathy Treatment with Hormonal drugs, Anti-Fibrinolytics and IUD Patients with Hypertension Patients with severe menstrual bleeding without diseases disorders N92.1 Excessive and frequent menstruation with irregular cycle Treatment - Drugs Treatment - Drugs Intervention group: Persian medicine capsule based on Persian Golnar 500 mg every 8 hours, from the beginning of the menstrual period to the end of the cycle Control group: Tranexamic Acid Capsule, 500 mg every 8 hours from the first day of menstruation for up to 5 days Menstrual bleeding score. Timepoint: One month before and one, two and three months after the intervention. Method of measurement: Pictorial Blood Loss Assessment Chart. Quality of Life. Timepoint: One month before the intervention and 3 months after the intervention. Method of measurement: Aberdeen Menorrhagia Questionnaire. Age. Timepoint: The beginning of the entry. Method of measurement: Question from sample. The numbers of menstruation days. Timepoint: The number of bleeding days in 3 cycles of menstruation. Method of measurement: Day. Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran University of Medical Sciences Approved 2018-05-18 Ethics Committee of Tehran University of Medical Sciences No. 28, Zahra Ave., Niroo Daryaee Ave; Resalat Sq Tehran Tehran Iran (Islamic Republic of)