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临床试验/CTRI/2025/03/083127
CTRI/2025/03/083127尚未招募2 期

An open label prospective clinical study of a protocol-based Ayurvedic intervention in male infertility due to Oligospermia

Amrita School of Ayurveda1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
39
试验地点
1
主要终点
Volume

研究概览

简要总结

Infertility is a problem of global proportions, affecting on an average 8-12% couples worldwide. Male infertility is considerably less complicated than Female infertility, but account for 30-40% of infertility.  Except for some physical defects, low sperm count &poor sperm quality are responsible for male infertility in more than 90% cases. Oligozoospermia (sperm count < 20 million /ml semen),in about 30-40% the cause is unexplained, and in the rest of the cases critical illness, malnutrition, genetic abnormalities, pollution, side effects of some medicines, hormones and chemicals play a major role Oligozoospermic conditions can be correlated to that of kshina shukra concepts in ayurveda. The pathogenesis of kshina shukra is not mentioned in the classics, but it is stated that the vitiation of vata and pitta dosha is responsible for the manifestation of kshina shukra. Sub- normal parameters of shukra includes dravya,guna,karma features of shukra.The main line of treatment of kshina shukra has been suggested to be’ kshine shukrakarikriya’ and upachaya is the primary line of treatment.  Drugs having vrishya, rasayana, and vajikarana properties can provide better results in the management of kshina shukra.  A protocol incorporated with rookshana,snehana,swedana(poorvakarma)  virechana and  vasti with shukra shodhana gana kwatham, will be capable of  relieving symptoms of Ksheena shukra. After shodhana karma, internal medication for Vajikarana, which can bring a markable change in Oligospermia cases.

Shodhana chikitsa followed by Samana chikitsa will be adopted

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
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Male

入选标准

  • Male subjects of Age group between 20-45 years
  • Sperm count less than 15million /ml.
  • Diagnosed cases of oligospermia
  • Subjects fit for Shodhana
  • Both fresh and treated cases will be included.

排除标准

  • Varicocele with surgical indication
  • Sexually Transmitted Disease
  • Subjects categorized under Azoospermia.
  • Tuberculosis, HIV, AIDS, CA Testis.

结局指标

主要结局

Volume

时间窗: Base line 0th day | fourth week | eighth week

pH

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Morphology

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Liquefaction time

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Sperm concentration

时间窗: Base line 0th day | fourth week | eighth week

次要结局

未报告次要终点

研究者

发起方
Amrita School of Ayurveda
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

K Parameswaran Namboothiri

Amrita School Of Ayurveda, Amritapuri, Amrita vishwa vidyapeetham, India

研究点 (1)

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