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IRCT2017010231722N1 IRCT 2017-04-10 Vice chancellor for reaserch, Iran University of Medical Science Comparison of the efficacy of capsule of “ Golnar” and Placebo on heavy menstural bleeding: A double- blind randomized clinical trial Comparison of the efficacy of capsule of “ Golnar” and Placebo on heavy menstural bleeding in 20- 40 years women: A double- blind randomized clinical trial 2017-02-19 anticipated 88 Complete https://irct.ir/trial/24896 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This is the double-blind study: participants and researchers do not know the type of drug or placebo was administered. Participants by Block Randomization will be divided into two groups.Then the drug and placebo accordance with the table are placed randomly in the hands of participants. 2 MENSTURAL BLEEDING. Intervention 1: Intervention 1.A 500-mg capsules Golnar 20 minutes after each meal for three menstrual cycles during the 7 days will be spent. Intervention 2: Intervention 2. A 500 mg capsules containing bread powder 20 minutes after each meal for three menstrual cycles during the 7 days will be spent.
public Hashem Dabaghian Fataneh
School of Traditional Medicine, Behesht Street, Vahdat Islami Street, Tehran
Tehran Iran (Islamic Republic of) +98 21 5563 9724 Fataneh.Dabaghian@yahoo.com Iran University of Medical Science- Traditional Medicine School scientific Hashem Dabaghian Fataneh
School of Traditional Medicine, Behesht Street, vahdat islami street, Tehran
Tehran Iran (Islamic Republic of) +98 21 5563 9724 fataneh.dabaghian@yahoo.com Iran university of science- Traditional medicine school Iran (Islamic Republic of) Inclusion criteria: • Informed written consent of patients • Age 40-20 years • Has bleeding more than 7 days • More than 80 cc blood loss (see Hygam chart ) • Endometrial thickness in ultrasound is normal which is equal to or less than 12 mm • Gynecological examination is normal • Pap smear results are normal • Patient has Hb≥11 Exclusion criteria: • Hemoglobin high level of 16 • Bleeding is so severe that emergency measures needed • Plan to become pregnant in the next three months • Catching Systemic or Pelvic inflammatory disease • Catching chronic diseases such as diabetes, lupus and thyroid problems • Catching Organic diseases such as cancer of the Uterus or ovaries or other malignancies • Conjugation of any herbal remedies or certain chemicals that interfere with the study drug or have an impact on menstrual bleeding Such as birth control pills containing estrogen and progesterone or just progestin • Pregnancy and lactation • Catching Known hyperprolactinemia • Catching sub-mucosal or intramural fibroids which are larger than 5 cm • The patient has no wish to consume these types of drugs 20 years 40 years Female N92.0 Excessive and frequent menstruation with regular cycle Treatment - Drugs Treatment - Drugs Intervention 1.A 500-mg capsules Golnar 20 minutes after each meal for three menstrual cycles during the 7 days will be spent. Intervention 2. A 500 mg capsules containing bread powder 20 minutes after each meal for three menstrual cycles during the 7 days will be spent. Bleeding volume. Timepoint: before and 3 month after intervention. Method of measurement: Higam chart(PBAC Questionaire). Duration of bleeding. Timepoint: before and 3 month after intervention. Method of measurement: Questionaire. Hemoglobin concentration. Timepoint: Before the intervention, and at the end of each menstrual cycle. Method of measurement: Hemiglobincyanide method, Hemoglobin measuring kit. Potential drug side effects. Timepoint: end of intervention. Method of measurement: Questionaire. Quality of life. Timepoint: Before and the end of intervention. Method of measurement: Menorrhagia Questionaire. Research Institute for Islamic and Complementary Medicine/ Iran University of medical science Vice chancellor for reaserch, Iran University of Medical Science Research Institute for Islamic and Complementary Medicine/ Iran University of medical science Approved 2016-12-27 Ethics Commitee of Iran University of Medical Science Iran University of Medical Science, Besides Milad Tower, Hemmat Highway, Tehran Tehran Iran (Islamic Republic of)