A randomized open-labelled comparative clinical study to evaluvate the efficacy of oral administration of Arjakadhi Vatika and Vanari Gutika with Phala Ghrita Matra Basti in Ksheena Shukra with special refernce to Oligospermia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Significant increase in Sperm Count assessed based on semen Analysis.
研究概览
简要总结
· Infertility is defined as a failure to conceive within one or more years of unprotected coitus (with adequate frequency i.e. 2-3 times a week).
· Oligospermia is among the prime factors in male infertility, and it is defined as a subnormal concentration of spermatozoa in the penile ejaculate.
· The prevalence of Oligospermia is amongst people who are accustomed to a sedentary lifestyle, alcohol addiction, Smoking, Caffeine intake and due to unhealthy food habits and irregular sleep Cycle.
· According to WHO 45% of Infertile Men were found to be affected by Oligospermia. And in India, the prevalence is around 23% in 2017.
· Oligospermia stands near to the term Ksheena Shukra which is among eight types of Shukra dushti mentioned in literatures*.*
· Commonly used pharmacological contemporary medicines include clomiphene citrate, tamoxifen, Hormone Replacement Therapies like FSH, HCG, Testosterone, which can cause various untoward effects like changes in libido, mood and energy level, weight gain, increased blood cell concentration and increased risk of blood clots.
· ICD-10-CM N46 is the billable/specific code that can be used to indicate the diagnosis of Oligospermia.
· Vajikarana is a branch of Ayurveda, deals with the promotion of sexual health, healthy progeny, treatment of infertility by increasing sperm count and motility.
· Although several research studies have been carried out, by keeping the prevalence of the disease and the importance of fertility in view,there is a necessity to find effective formulation for the management of Ksheena Shukra with special reference to Oligospermia.
· In Shodana chikitsa Basti karma is considered as best treatment for Shukra dosha. Basti karma is Pradhana karma which is mentioned as Ardha chikitsa.
· Phala ghrita mentioned in Astanga hridaya uttara sthana consists ofManjistha, Kustha, Tagara, Haritaki, Bibhitaki, Amalaki, Sharkara, Vacha, Haridra, Daruharidra, Madhuka, Meda, Dipyaka (yavani), Katurohini, Payasya, Hingu, Kakoli, Ashwagandha, Shatavari, Ghrita, Ksheera.
· Arjakadi vatikamentioned in Bhaishajya ratnavali in the context of Veerya sthambaka Adhikara consists of Shweta musali, Kapikachhu,Shanka pushpi ,Nirgundi , Jayaphala , Lavanga , Vidanga , Gaja pippali , Chaturjata , Vamshalochana , Ananta moola , Shweta tulsi , Shatavari , Bhringaraj moola, Vidari kanda , Gokshura , Jatiphala. The properties of the ingredients are Vrishya and Brimhana seem to be promising in the management of Ksheenashukra.
· Vanari gutika mentioned in Yogaratnakara consists of Kapikachhu, Suvarna Sutashekara , Twak ,Suvarna Makshika Bhasma , Pippali moola , Ela , , Nagakesara , Lavanga ,Pippali ,Shuddha Shilajatu , the properties of the ingrediants like Vrishya and Rasayana seem to be promising in the management of Ksheenashukra.
· Hence, considering the above background, it was thought worthy to evaluate the efficacy of oral administration of “Arjakadi vatika” in the management of Ksheenashukra with special reference to Oligospermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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.) Subjects diagnosed with Oligospermia 2.) Subjects between the age group of 21 to 50 years 3.) Subjects those are fit for Matra basti 4.) Subjects who are willing to give informed consent, which is conveyed in the language,which the subject can understand.
排除标准
- •1.) Subjects of azoospermia and aspermia 2.) Subjects diagnosed with sexually transmitted diseases 3.) Subjects diagnosed with Varicocele 4.) Subjects with Genetic disorders 5.) Subjects diagnosed with uncontrolled systemic disorders which might interfere in the course of disease and treatment.
结局指标
主要结局
Significant increase in Sperm Count assessed based on semen Analysis.
时间窗: 0th , 30th day and 60th day
次要结局
- Generation of in depth analyzed data on the different aspect of disease(0th , 60th day)
研究者
Dr T K VENKATESH
Sri Sri College Of Ayurvedic Science and Research Hospital.
