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临床试验/CTRI/2024/10/074602
CTRI/2024/10/074602已完成2 期

A Comparative Clinical Study To Evaluate The Efficacy Of Nrupavallabha Taila Nasya And Abhijita Taila Nasya In Prathamapatalagata Timira With Special Reference To Simple Myopia

Dr Abhishek1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月11日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
1. Visual Acuity- Manually Done Using Snellens chart.

研究概览

简要总结

Prathama Patalagata Timira is one among the Dristigata Netrarogas. Avyakta Roopa/Darshana (Blurriness of vision) mentioned under Prathama Patalagata Timira1.

The lakshanas of Prathama Patalagata Timira can be correlated with the signs and symptoms of Simple or developmental Myopia in Modern Ophthalmology. Simple or developmental Myopia is the most common refractive error seen in young children with prevalence rate 20-40% of population2.

According to an article published in OPO, journal of the college of optometrists, The prevalence of myopia in 5 to 15-year-old urban children increased from 4.44% in 1999 to 21.15% in 2019. Their predictions, based on the slope of 0.8% every year (4.05% for every 5 years) indicate that the prevalence of myopia will increase to 31.89% in 2030, 40.01% in 2040 and 48.14% in 2050. Due to the generational effect (caused by the nature of the condition lasting a lifetime once developed), there will be an overall increase in myopia prevalence across all age groups of 10.53% in the next three decades (2020 to 2050)3.

As such there is no effective treatment for myopia, only optical correction by spectacles or contact lenses to restore distant vision is advised. It’s just an aid to improve the diminished vision. Meanwhile it fails to decrease complications like glaucoma, cataract, retinal detachment and risk of posterior segment sequel of myopia. Surgical intervention is advised only in condition of stabilized myopia and complication such as dry eye and night glare are common. Moreover the cost of surgery makes it fearful and less opted procedure. Hence an alternative treatment which is safe, devoid of complication, easy to administer and cost effective is need of hour.

In classics different shodhana kriyas like virechana, basti and nasya along with kriyakalpas4 like Tarpana , Putapaka, Aschotana and anjana etc., are explained in the treatment of Netrarogas. Nrupavallabhataila5 Nasya and Abhijitataila6 Nasya is mentioned in Bhaishajya Ratnavali, Netrarogadhikara. Hence an attempt is made to compare the efficacy of Nrupavallabhataila5 Nasya and Abhijitataila6 Nasya in the management of Prathama Patalagata Timira.

NULL HYPOTHESIS

H0– Nrupavallabhataila Nasya is not effective in the management of Prathama Patalagata Timira with special reference to Simple Myopia.

ALTERNATE HYPOTHESIS

H1*-* Nrupavallabhataila Nasya is more effective than Abhijita Taila Nasya in the management of Prathama Patalagata Timira with special Reference to Simple Myopia.

H2-Nrupavallabhataila Nasya is less effective than Abhijita Taila Nasya in the management of Prathama Patalagata Timira with special Reference to Simple Myopia.

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
12.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Subjects irrespective of gender, caste and religion.
  • Subjects between the age group of 12 years to 30 years.
  • Subjects presenting with clinically established cases of simple myopia
  • Patients having -0.25 to -3.00 D of vision.

排除标准

  • Pathological myopia, High myopia with degenerative, gross retinal changes and Astigmatism.
  • Myopia associated with structural deformities like corneal opacity, keratoconus, keratoglobus.
  • Subjects who have underwent any of the refractive surgeries.
  • Subjects who are contraindicated for Nasyakarma.

结局指标

主要结局

1. Visual Acuity- Manually Done Using Snellens chart.

时间窗: 30 Days

2. Autorefractometry

时间窗: 30 Days

次要结局

  • Blurred Vision(30 Days)

研究者

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

Dr Abhishek

Govt Ayurveda Medical College,Bangalore

研究点 (1)

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