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临床试验/NCT02998593
NCT02998593Unknown3 期

Effect of Red and White Bahman on Semen Parameters,Testosteron ,LH, FSH and Defragmentation of DNA . A Double Blind Randomised Clinical Trial (Phase 3)

Royan Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
200
试验地点
1
主要终点
Semen analysis

研究概览

简要总结

This study is a prospective double blind randomized controlled trial to investigate the effect of red and white bahman on semen parameters, sexual hormones and DNA defragmentation in idiopathic oligospermic men .Include patients will take the medicine and placebo in different two case and control groups for 3 month and semen parameters and other variants at the start and end of study.

详细描述

This is a randomized, double blind; placebo-controlled clinical trial has been started from july 2016 and will continue to july 2016 in Royan institute. The eligible patients who fulfilled the study criteria will be included in the trial.

Study protocol and assays All the patients will have a complete history evaluation and physical examination by the attending urologist who is blinded to the study and enter the study according to inclusion criteria.. semen analysis and hormonal laboratory tests [Testosterone, Luteinizing hormone (LH) Follicle stimulating hormone(FSH)] will done in same lab at start of study and 3 month after. Intervention time is 3 month for each patient. semen analysis wil be done according to who laboratory manual for the examination and processing of human semen 5th edition and hormonal tests (LH,FSH,Testosterone) with Elisa method (with score of International Unit). DNA Defragmentation will evaluate with Sperm Chromatin Structure Assay(SCSA) method. semen parameters which will evaluate is the number of normal and abnormal shape sperms, velocity of sperms, volume and viscosity of semen at start and end of the study. medicine and placebo prescribe in 500mg capsules for 3month. red and white Bahman is an effective medicine in male infertility treatment In Iranian Traditional Medicine. at the end of study main aim of the study is evaluation effect of combination of Red and White Bahman retrieved of Iranian Traditional Medicine on Semen Parameters in Idiopathic Oligospermic . Red Bahman and White bahman ,nutrition ,placebo, smoking and Testosterone,LH,FSH,Concentration,number,sha-pe,of sperm before and after the study is variables of study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • all idiopathic oligospermic patient in range of 20 to 45 years old
  • sperm count under 15 million /ml 3;No history of taking chemical or herbal medicine effective on sperm genesis in last 3 month( like Hormonal drug ,antidepressant ,anti hypertension,cimetidine, cyproteron, sulphasalazine, flutamide, spironolactone, estrogen,opium 4:No history of Varicocele and Obstructive disease 5:;No leukocytospermia

排除标准

  • Taking chemical or herbal medicine effective on spermatogenesis (hormonal and sperm reducing and increasing agent);
  • ; Increasing BMI > 30
  • Leukocytospermia

研究组 & 干预措施

extracted red Bahman and white bahman

Experimental

500 mg of extracted red Bahman and white bahman that is used once a day.

干预措施: Bahman capsules (Drug)

Placebo

Placebo Comparator

500 mg of placebo once time a day

干预措施: Placebo (Drug)

结局指标

主要结局

Semen analysis

时间窗: 3 months

Performing the semen analysis to evaluate the sperm count ,sperm motility and sperm morphology.

次要结局

  • Testosterone(3 months)
  • FSH(3 months)
  • LH(3 months)
  • DNA defragmentation(3 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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