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临床试验/CTRI/2025/07/091495
CTRI/2025/07/091495尚未招募2/3 期

A SINGLE ARM CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SUKRALA BASTI IN KSHEENA SUKRA OLIGOSPERMIA

Dr ANAGHA KOMALANKUTTY1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate efficacy of Masha Atmaguptadi Basti in the management of Ksheena Sukra (Oligospermia)

研究概览

简要总结

Oligospermia, characterized by a low sperm count, is a significant cause of male infertility. Ayurveda attributes this condition to Shukra Kshaya, primarily influenced by Vata and Pitta doshas. Basti Karma, is considered effective in addressing Vata-related disorders and has been postulated to enhance male reproductive health.

Objective: This study aims to evaluate the efficacy of Masha Atmaguptadi Basti in improving semen parameters in Ksheena Shukra (Oligospermia) and to assess the path of Basti Dravya within the colon.

Methods: A single-arm, open-label clinical trial will be conducted on 30 male patients diagnosed with Oligospermia, recruited from Alva’s Ayurveda Medical College and Dhatree Fertility Centre. The intervention involves the administration of Masha Atmaguptadi Basti over a specified treatment schedule. Semen parameters, including sperm count, motility, morphology, and density, will be assessed pre- and post-treatment. Statistical analysis will be conducted using paired t-tests and Wilcoxon signed-rank tests.

Expected Outcome: The study hypothesizes a significant improvement in semen parameters post-treatment, supporting the role of Masha Atmaguptadi Basti in managing Oligospermia.

Conclusion: This study aims to contribute scientific evidence to the Ayurvedic management of male infertility, potentially validating the efficacy of Basti therapy in enhancing sperm count and overall reproductive health.

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
25.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • Patients of age group 25 to 50 years with total sperm concentration less than 15 million per ml.
  • Patients with duly written consent.

排除标准

  • Chronic uncontrolled Diabetes mellitus.
  • Hypertension Azoospermia and Aspermia Diagnosed case of Genetic defect like Klinefelter syndrome Bilateral Varicocele Accessory sex gland infections Diagnosed cases of STDs H/O lower lumbar spinal injury.

结局指标

主要结局

To evaluate efficacy of Masha Atmaguptadi Basti in the management of Ksheena Sukra (Oligospermia)

时间窗: 82 days

次要结局

  • To find the path of the Basti Dravya on administration in colon(By Semen analysis following will be evaluated)

研究者

发起方
Dr ANAGHA KOMALANKUTTY
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr ANAGHA KOMALANKUTTY

ALVAS AYURVEDA MEDICAL COLLEGE

研究点 (1)

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