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临床试验/NCT01895816
NCT01895816已完成3 期

Phase 3 of Study on Effects of New Herbal Mixture on Men Infertility

Arash Khaki2 个研究点 分布在 2 个国家目标入组 1 人开始时间: 2012年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1
试验地点
2
主要终点
Sperm count variation

研究概览

简要总结

The purpose of this study is to determine whether the effect of mixed herbals drug (citrus, citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male infertility: oligospermia

详细描述

In the last few years, a marked decrease in the quality of semen has been reported. Infertility is one of the major health problems in 10 to 15% of couples' lives; from which approximately 50% of couple's infertility is due to Male factors. The aim of the present study was to evaluate an herbal mixed effects on spermatogenesis and the normal production of sperm. Researchers have reported that using antioxidants and vitamins A, B, C, E, flavonoids, Sulfur compounds, terpenoids and phenolic compounds in the daily diet can protect sperm. In this study the investigators aimed to assess synergistic effect of these herbal compounds in male Infertility. 700 mg tablet for 180 consequence days/daily will be advising, for 40 patients semen samples in 1th and 180 day after treatment will take, in andrology lab according WHO method:samples put into 2 mL of medium (Hams F10) containing 0.5% bovine serum albumin. After 5 min incubation at 37oC (with 5% CO), the sperm samples were determined using the standard haemocytometric method, and sperm motility was analyzed by microscope (Olympus IX70) at 10 field and reported as the mean of motile sperm according to WHO methods . The sperm abnormality was evaluated according to the standard method of Narayana .Briefly, smears of the sperm suspension were made on clean glass slides and stained with periodic acid-Schiff's reaction haematoxylin. The stained smears were observed under a light microscopic with 40× magnification. The sperms were classified into normal and abnormal. The total sperm abnormality was expressed as percentage incidence. Other biochemical tests will be doing according the our research protocol and thesis for blood samples for measure LH, Testosterone, TAC, Glc and Cholesterol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • all patients suffering from oligospermia are included

排除标准

  • any diseases

研究组 & 干预措施

fertility coated tablet

Experimental

700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days

干预措施: coated tablet (Dietary Supplement)

结局指标

主要结局

Sperm count variation

时间窗: First day of research, 2th time for sampling is 180 days after treatment

Semen analysis according WHO methods

次要结局

  • Sperm motility(1th time in first day of research, 2th time after 180 days of treatment)
  • Sperm Viability(1th time in first day of research, 2th time after 180 days of treatment)

研究者

发起方
Arash Khaki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arash Khaki

Clinical professor. Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Islamic Azad University of Tabriz

研究点 (2)

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