Single centric non randomised open clinical trial phase II in “Aan maladuâ€(Male infertility due to Oligospermia) with Siddha medicine “Vithuvagai chooranam†among the patients attending OPD at Government siddha medical college hospital, Chennai
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1)Increased sperm count.
研究概览
简要总结
Infertility is one of the medical conditions that affect millions of people worldwide. It
is also a global problem in the field of reproductive health and is one of the major
contributors for the decline in birth rate.
Infertility is a clinical condition defined by the failure to achieve a clinical pregnancy in
12 or more months of regular unprotected sexual intercourse. In male reproductive
system, infertility is most commonly caused by the problems in ejaculation of semen,
absence or low level of sperm or abnormal shape(Morphology) and movement(Motility)
of the sperm.
According to the statistics collected from the World Health Organization (WHO), it
is estimated that around 60 to 80 million couples worldwide currently suffer from
infertility. Many couples assume that infertility is a female problem and is called a social
stigma, but in the general it is only 15% to 20%, but the male is responsible for 20 to
40%.In a World Health Organization multicenter study, 45% of infertile men were found
to have either Oligo-zoospermia or Azoospermia.
According to WHO’s 2010 guidelines, the qualities of Semen required for fertility
are:(1) Volume of Semen per ejaculation must be at least 1.5 ml (2) Sperm count must
be at least 15 million /ml (3) Number of Sperm in each ejaculation must be at least 39
million (4) 58% of Sperm per ejaculation must be alive (5) 40% of sperm must be
Motile (6) 30% of Sperm must have normal shape and structure. Oligospermia is
decrease in the sperm concentration in semen below 15 million sperm per milliliter
(WHO, 2010).
In Siddha system of Medicine, there are unique combination of medicines which
have a solution for MALE INFERTILTY. One such combination is VITHUVAGAI
CHOORANAM which is a classical Siddha Herbal formulation mentioned in
NOIGALUKKU SIDDHA PARIGAARAM, PAGE NO 300, for the treatment of Aan
Maladu (Male Infertility). The therapeutic efficacy of this Siddha formulation is so far
not evaluated scientifically, so the author tries to evaluate its efficacy in an open clinical
trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male infertile Oligospermia Oligoasthenozoospermia Patient willing to give specimen of semen, blood for investigation Patient willing to give consent for the study.
排除标准
- •Azoospermia Teratospermia Hydrocele Varicocele Diabetes mellitus Klinefelter syndrome Congenital disorders.
结局指标
主要结局
1)Increased sperm count.
时间窗: 12 months
Severe Oligospermia to Moderate Oligospermia
时间窗: 12 months
Mild Oligospermia or Normal Moderate Oligospermia to Mild Oligopermia or Normal.
时间窗: 12 months
Mild Oligospermia to Normal
时间窗: 12 months
2)Improved motility function.
时间窗: 12 months
Immotile to Non progressive motility or Progressive motility.
时间窗: 12 months
Non progressive motility to Progressive motility.
时间窗: 12 months
次要结局
- Improvement in General wellbeing(12 months)
研究者
Vignesh S
Government Siddha medical college Arumbakkam