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临床试验/CTRI/2024/07/070805
CTRI/2024/07/070805尚未招募1 期

A Comparative Clinical Study to Assess the Efficacy of Sapta Prasrutika Basti and Mahamasha Taila Matra Basti followed by Vrushya Ghrita in the Management of Kshina Shukra with special reference to Oligozoospermia

National Institute of Ayurveda DU1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. Changes in the sperm count

研究概览

简要总结

·       Oligozoospermia is one among the prime factor in the male infertility.

·       In conventional system, various drugs indicated in oligozoospermia are expensive and produces several adverse effects like gynecomastia, hepatic carcinoma, deep vein thrombosis, dyslipidemia.

·       Acharya has mentioned the different Type of drugs for Ksheena Shukra. under Vajikarana Adhyaya. Clinical studies from many ayurvedic institute reveal that ayurvedic drugs are potentially effective in Oligozoospermia.

Therefore, keeping all these facts in mind, it has been decided to conduct the study.

·       RESEARCH QUESTION: Is there any difference between the effect of Sapta Prasrutika Yapana Basti And Mahamasha  Taila Matra Basti followed by Vrushya Ghrita In the Management Of Kshina Shukra With Special Reference To Oligozoospermia?

·       NULL HYPOTHESIS (H0): There is no difference in the effect of Sapta Prasrutika Yapana Basti And Mahamasha Taila Matra Basti**followed by Vrushya Ghrita in the management of Kshina Shukra (oligozoospermia)

·       ALTERNATIVE HYPOTHESIS (H1)Sapta PrasrutikaYapana**Basti along with Vrushya Ghrita is more effective than Mahamasha Taila Matra Basti followed by Vrushya Ghrita in the management of Kshina Shukra (oligozoospermia).

·       ALTERNATIVE HYPOTHESIS (H2): Mahamasha Taila Matra Basti along with Vrushya Ghrita is more effective than Sapta Prasrutika Yapana**Basti followed by Vrushya Ghrita in the management of Kshina Shukra (oligozoospermia).

·       AIM: To compare the effect of Sapta Prasrutika Yapana Basti and Mahamasha Taila Matra Basti along with Vrushya Ghrita in the management of Kshina Shukra (Oligozoospermia).

·       OBJECTIVES: To assess the effect of Sapta PrasrutikaYapana**Basti along with Vrushya Ghrita in the management of Kshina Shukra (Oligozoospermia).

·       To assess the effect of Mahamasha Matra Taila Bastialong with Vrushya Ghrita byin the management of Kshina Shukra (Oligozoospermia).

·       To assess the comparative effect of Sapta Prasrutika Yapana Basti and Mahamasha Matra Taila Bastialong with Vrushya Ghrita in the management of Kshina Shukra (Oligozoospermia).

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

  • Male patients age between 21-50 years.
  • Patients having sperm count below 15 million per ml.
  • Patients those are fit for Basti Karma (Niruha & Anuvasana) & Snehapana.

排除标准

  • Known case of various diseases like accessory sex gland infection,
  • Sexually transmitted diseases, severe systemic disease & Uncontrolled DM-II & HTN.
  • IHD, severe bilateral Varicocele, malignancy, Genetic disorders like Klinfelter’s syndrome.
  • Taking treatment for major psychiatric problem & Anti-epileptic drugs.
  • History of trauma leading to Oligozoospermia.

结局指标

主要结局

1. Changes in the sperm count

时间窗: Patient will evaluated on Day 0 and on Day 28 after procedures completed

2. Changes in the volume, pH and viscosity of semen

时间窗: Patient will evaluated on Day 0 and on Day 28 after procedures completed

次要结局

  • 1. Changes in the WHO Asessment criteria for Semen analysis(Day 0 & Day 28)

研究者

发起方
National Institute of Ayurveda DU
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kalidas V

National Institute of Ayurveda, Jaipur

研究点 (1)

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