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临床试验/CTRI/2022/06/043602
CTRI/2022/06/043602尚未招募2/3 期

Evaluation of shukra-vardhana effect of shivalingi beej(Bryonia laciniosa L.) in the management of kshina- shukra or oligospermia in adult Males : A randomised double arm double blinded placebo control clinical trial.

All India Institute Of Ayurveda1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年1月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
66
试验地点
1
主要终点
Improvement in the total sperm count more than 15 million per ml

研究概览

简要总结

Sexual health is an important aspect of every individual. Problems related to sexual health remain serious issue, particularly in young adults Infertility affects an estimated 15% of couples globally, amounting to 4KS million couples. The calculated global data shows that the percentage of infertility that is attributable to males ranged between 20.20%, and that the percentage of infertile men ranged from 2-5% to 12%, WHO estimate the overall prevalence of primary infertility in India is between 3,9 to 16.8 Indian states prevalence of infertility varies from state to suite such a 37 per cent in Uttar Pradesh, Himachal Pradesh and Maharashtra, so per cent in Andhra Pradesh and 15 per com in Kashmir and prevalence varies in same region across

tribes and caste.

There is a regional variation in the prevalence of anospermia and oligozoospermia in the male partners of infertile couples from different reations of India. The prevalence of azospermia is extremely high in Kurnool and lodhpur (38.3% and 37.4%, respectively). There is also a regional variation in the prevalence of oligozoospermia (31%) in Kurnool

Ayurvedic classics have mentioned that the reproduction is the work of Shidra dhatu, kahina shikra is one of the eight types of Shukradhushti mentioned in the classics. Various drugs have been mentioned in Aurveda classics which act on Kshina-shukru. The drug Shivalingi is mentioned in raj nighantu as rasayani and sarv-siddhikara. The reference of Shivalingi found in In Bhavprakash Samhita for vandhyarva chikitsa as the seeds of Shivalingi are taken with milk which provide male progeny to pregnant mother. Shivalingi belongs to group of valuable drugs in the area of therapeutics of sterility and infertility disorders.

In modern medicines the conditions associated with Kshina-Shukra in ayurveda can be well matched with Oilgospermia. In this condition the sperm count comes below 15 milli/ml." According to ethnomedicinal review Shivalingi have aphrodisiac and -spermatogenic effect. The drug selected for this work is Shivalingi Beej (Bryonia laciniosa L.) and the drug is already evaluated for its Physicochemical, phytochemical study and pre-clinical study but the clinical study has not been conducted yet.

Considering this, present study has been undertaken to evaluate the Shukra vardhan Efecct of Shivalingi Beej

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
Male

入选标准

  • Sperm count below 15 million/ml
  • Patient with clinical presentation of kshina-shukra mentioned in classics i.e, Daurbalya, panduta,sadana shrama, klaibya, maithuna ashakti, chiraat praseka, shukra avisarga, medhra-vrishana vedanaa.

排除标准

  • Sperm count > 15million/ml
  • Patient of azoospermia and aspermia
  • patients suffering from varicocele, accessory sex gland infection, sexually transmitted diseases, severe systemic diseases etc.

结局指标

主要结局

Improvement in the total sperm count more than 15 million per ml

时间窗: 45 days

次要结局

  • Improvement in symptoms of kshina-shukra & other seminal parameters with crf(45 days)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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