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IRCT20200118046171N1 IRCT 2020-02-03 Islamic Azad University The Effect of Vitex Agnus Castus Extract on Blood Level of Prolactin & It,s Hormonal, Metabolic & Histological Effects in Comparison with Bromocriptin & Dostinex in Hyperprolactinemic Women The Effect of Vitex Agnus Castus Extract on Blood Level of Prolactin & It,s Hormonal, Metabolic & Histological Effects in Comparison with Bromocriptin & Dostinex in Hyperprolactinemic Women 2016-09-22 anticipated 105 Complete https://irct.ir/trial/45079 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Personnel of laboratory, radiology & clinical care,was blind. 2-3 Hyperprolactinemia.. Intervention 1: Intervention group: Oral bromocriptine,as protocol:1-3 tablet daily (each tablet contents 2.5 mg bromocriptine mesylate), Iran Hormone, for 4 menstrual cycles. Intervention 2: Intervention group:Oral ِDostinex,as protocol:2-4 times weekly half a pill (each tablet contents 0.5mg Cabergoline),Italy PFIEZER ,for 4 menstrual cycls. Intervention 3: Intervention group: Oral Vitagnus,2-4 tablet daily(each tablet contents 3mg extract of Vitex Agnus),Pour Sina, for 4 menstrual cycls. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not another information.
public Naiyereh Haerifar
Islamic Azad university , Pasdaran Blvd
Tabriz Iran (Islamic Republic of) 5157944533 +98 41 3196 6522 naiyereh.haerifar@gmail.com Islamic Azad University scientific Zahra Ghatreh Samani
department of Gynaecology,Tabriz Branch,Islamic Azad University, Tabriz,Iran
Tabriz Iran (Islamic Republic of) 5157944533 +98 912 811 9022 naiyereh.haerifar@gmail.com Islamic Azad University Iran (Islamic Republic of) women with hyperprolactinemia Age 18-45 confirm letter of satisfaction 18 years 45 years Female Pregnancy Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Oral bromocriptine,as protocol:1-3 tablet daily (each tablet contents 2.5 mg bromocriptine mesylate), Iran Hormone, for 4 menstrual cycles Intervention group:Oral ِDostinex,as protocol:2-4 times weekly half a pill (each tablet contents 0.5mg Cabergoline),Italy PFIEZER ,for 4 menstrual cycls Intervention group: Oral Vitagnus,2-4 tablet daily(each tablet contents 3mg extract of Vitex Agnus),Pour Sina, for 4 menstrual cycls Blood level of prolactin. Timepoint: One week before treatment,One, Two, Three & Four menstrual cycle after starting treatment. Method of measurement: sampling of blood serum. Total Cholesterol. Timepoint: Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles. Method of measurement: Vein Blood sampling. LDL Cholesterol. Timepoint: Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles. Method of measurement: Vein Blood sampling. HDL Cholesterol. Timepoint: Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles. Method of measurement: Vein Blood sampling. Triglyceride. Timepoint: Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles. Method of measurement: Vein Blood sampling. Follicle stimulating hormone (FSH). Timepoint: Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles. Method of measurement: Vein Blood sampling. Luteinizing Hormone (LH). Timepoint: Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles. Method of measurement: Vein Blood sampling. Estradiol. Timepoint: Before Intervention and for 4 cycles with Intervention, Between 11-13 days of menstrual cycles. Method of measurement: Vein Blood sampling. Progesterone. Timepoint: Before Intervention and for 4 cycles with Intervention, Between 17-22 days of menstrual cycles. Method of measurement: Vein Blood sampling. Thickness of endometrium. Timepoint: Before Intervention and for 4 cycles with Intervention, Between 1-3 days of menstrual cycles. Method of measurement: Abdominal Sonography. Islamic Azad University Approved 2016-06-14 Ethics committee of medical science faculty,Tabriz Branch, Islamic Azad University. Islamic Azad university of Tabriz, Pasdaran Blvd. Tabriz East Azarbaijan Iran (Islamic Republic of)