CTRI/2024/07/070801招募中3 期
A Comparative Clinical Study To Evaluate The Effect Of Narasimha Churna And Gokshuradi Churna In The Management Of Ksheena Shukra W.S.R. to Oligospermia
Dr Ronaksinh kher1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect Of Trial Drug On Improvements In The Symptoms Of Ksheena Shukra (Oligospermia)
研究概览
简要总结
- Male infertility is a major health problem across the world. One of the main reasons for male infertility is extreme low sperm count which affect the ability to conceive. Oligospermia is a condition wherein sperm count is less than 15 million/ml and is multifactorial in origin, such as unhealthy lifestyle, lack of physical activity, high pressure jobs, poor diet, alcoholism, smoking and tobacco chewing.
- In India nearly 50% of infertility is related to the reproductive anomalies or disorders in the male of which 90% are related to oligospermia.
- Oligospermia can be correlated with Ksheena Shukra. In Ksheena Shukra Vata and Pitta Dosha undergo vitiation and disturb the normal physiology of Shukra Dhatu. Vrushya Chikitsa like Dhatu Upachaya (Shukra Janana) is beneficial. The Vrushya/Rasayana Dravyas having properties like Madhura, Tikta, Snigdha & Guru should be administered.
- Hence Narasimha Churna mentioned in Bhaishajya Ratanavali is selected as trial drug and compare its effect with Gokshuradi Churna in the management of Ksheena shukra (Oligospermia) The study is a Randomised controlled clinical trial. 40 patients of Oligospermia will be selected incidentally and randomly assigned into two groups; Group ‘A’ and ‘B’ by software generated chart. Group A patients will be given Narasimha Churna and Group B will be Gokshuradi Churna respectively.
- Total Study duration will be 60 days and contain 4 visits (0th day, 15th day,31st day, 60th day.), which includes administration of trial drug for 30 days and post medication follow up on 60th day. After study, data will be collected from case report form (CRF) and statistically analysed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results, conclusion will be drawn.
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.Patients presenting with Pratyatma Lakshana (Daurbalya, Shukra Avisarga, Medra Vrushanavedana, Maithuna ashakti Mukhasosha Panduta, Sadana, Shrama, Klaibya) of Ksheena sukra.
- •2.Diagnosed cases of Oligospermia.(Sperm count less than 15 million/ml) 3.Male patient with the age 21 to 50 years.
- •4.Patient with abnormal sperm motility will also be included in the study.
- •5.Subjects willing to sign consent will be included.
排除标准
- •1.Diagnosed cases of varicocele, accessory sex gland infection, sexually transmitted diseases, benign prostatic hyperplasia.
- •2.Diagnosed cases of azoospermia and aspermia.
- •3.Diagnosed cases of genetic defects like Klinefelter syndrome and mosaic variants.
- •4.Diagnosed cases of major systemic illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes.
- •5.K/C/O uncontrolled hypertension, uncontrolled diabetes and taking treatment for psychiatric illness.
结局指标
主要结局
Effect Of Trial Drug On Improvements In The Symptoms Of Ksheena Shukra (Oligospermia)
时间窗: 15day, 31day, 60day
次要结局
- Safety Of Trial Drug And Adverse Drug Reaction And Aggravation Of Symptoms Of Ksheenashukra (Oligospermia)(15day, 31day, 60day)
研究者
Dr Ronaksinh Kher
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
研究点 (1)
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