Evaluation of a Capsule of Golnar in Dysfunctional Uterine Bleeding and Comparison with Tranexamic acid

Evaluation of effectiveness of Golnar Capsule and its comparison with transaxamic acid

Clinical trial with interventional and control group, parallel groups, double blind, randomized blocks, with sample size of 40 people per group and 3 month study for each person. At first, 90 capsules are given, and for the next two months, a medication is given at the time of the referral of the patient.

Arash Hospital, Tehran University of Medical Sciences. In the intervention group, 500 mg Golnar capsule was taken every 8 hours from the first day of menstruation for three consecutive cycles and in the control group 500 mg of tranexamic acid every 8 hours from one to fifth day of Menstruation is prescribed for three consecutive cycles. For blindness in the control group, after the fifth day, placebo capsules are used. Medications can be differentiated only through codes A and B. The person and the researcher are not aware of the concept of codes.

Inclusion criteria: Women 18-50 years old; Natural pap smear; Regular menstrual cycle; Endometrium thickness less than 10 mm; Severe or prolonged menstruation; Normal Gynology Examination Exclusion criteria: Pregnancy, Decision to pregnancy in the next three months, Lactation, Coagulation disorder, Systsmic diseases; Disorder in FSH and LH; hemoglobin less than 10; endometrial disorder, Uterus cancer ;leiomyoma and fibroids more than 4 cm; endometriosis; Hemoglobinopathy; hormonal drugs, anti-fibrinolytic، IUD; HTN; undisabling menstrual bleeding

In the intervention group, Golnar capsules 500 mg every 8 hours from the beginning of the menstrual period to the end of the cycle and in the control group, Tranexamic acid,500 mg, every 8 hours from the first day of the menstrual period to 5 days, for 3 cycle

Menstrual bleeding; Quality of life;

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.

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.

Expression of the procedure and drug used and treatment results

Six months after completing the results analysis

Data will be available to researchers working in academic and academic institutions

Analysis on the data with the permission of the investigating officer is preventable.

E-mail, Dr. Somayeh Eshaghee Ashtiany

Six months after data analysis