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临床试验/CTRI/2024/06/068483
CTRI/2024/06/068483尚未招募3 期

A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Saraswata Ghrita and Madhuyastyadi Churna followed by Koshtha Shuddhi with Haritakyadi Churna in the Management of Ksheena Shukra (Oligozoospermia)

National Institute of Ayurveda Deemed to be University Jaipur1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月4日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Changes in sperm count.

研究概览

简要总结

Oligozoospermia is a condition where sperm count is below 15 million/mL. Some of the known responsible factors for male infertility are poor semen quality, genetical factors, testicular dysfunction and endocrine dysfunction. Vajikaran is an important treatment modality as per Ayurveda and proposed benefits are manifold including increased sexual capacity , improving health of future progeny as well as in treatment of any common sexual disorders like infertility , erectile dysfunction and premature ejaculation. Vajikaran or vrishya chikitsa is the one of the eight major speciality of the Ashtanga Ayurveda. Aim of this study is to evaluate and compare the efficacy of Saraswata Ghrita and Madhuyashtyadi Churna after Koshtha Shuddhi with Haritakyadi Churna in the management of ‘Ksheena Shukra’ (Oligozoospermia).Study is designed as an Interventional, Single Centred, Randomized Comparative Clinical trial. Subjects will be screened according to WHO diagnostic criteria for oligozoospermia and will be allocated randomly into two groups of 20 in each. The total duration of the study will be 90 days. Assessment will be based on Changes in sperm count, Serum Testosterone, LH and FSH level, sperm motility, volume, morphology and subjective parameters at baseline and end of the trial.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • 1.Age: between 21– 50 years.
  • 2.Patients of Sperm count less then 15 million/mL.
  • 3.Patients having any sign and symptoms of 4.KsheenaShukra (Oligozoospermia).

排除标准

  • Patients with primary and secondary Azoospermia.
  • Patients with chronic diseases like Hypertension, COPD, DM, CAD, Renal failure and hepatic dysfunction.
  • Patients having any sexually transmitted diseases or HIV.
  • Known case of male infertility due to mumps, orchitis, diseases like hydrocele, varicocele and undescended testes.

结局指标

主要结局

Changes in sperm count.

时间窗: At baseline and 90th day

次要结局

  • Changes in the Serum Testosterone, LH and FSH level.(Changes in sperm motility, volume, morphology.)

研究者

发起方
National Institute of Ayurveda Deemed to be University Jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Bharat Singh

National Institute of Ayurveda Deemed to be University Jaipur

研究点 (1)

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