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临床试验/CTRI/2025/10/096611
CTRI/2025/10/096611尚未招募2/3 期

A Randomized Controlled Clinical Trial to Assess the Effectiveness of Krushnadya Taila Nasya and Spectacle Correction in the Management of Dwitiya Patalgata Timira (Presbyopia)

Dr Rashmi Vijay Deole1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年1月1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
70
试验地点
1
主要终点
To study the effect of Krushnadya Taila Nasya and spectacle correction in symptoms of Dwitiya

研究概览

简要总结

This randomized controlled clinical trial aims to evaluate the effectiveness of Krushnadya Taila Nasya along with spectacle correction in the management of Dwitiya Patalgata Timira (Presbyopia).Presbyopia is a common age related condition causing difficulty in near vision due to loss of accommodation. Total 70 patients aged 35-55 years with clinical features of Dwitiya Patalgata Timira will be randomly divided into two groups : the control group will receive spectacle correction only, while the trial group will receive Krushnadya Taila Nasya once daily for 30 days along with spectacle correction. Assessment will be based on subjective parameters like near vision, needle threading, eye strain and headache and objective parameters such as Near Point of Accommodation (RAF rule) and A-Scan measurements. Data will be statistically analysed to determine the efficacy  of Krushnadya Taila Nasya in improving near vision and reducing presbyopic symptoms compared to spectacle correction alone.

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
35.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients age between 35 to 55 years of age.
  • Patients of either gender.
  • Patients having near vision less than N6 with best corrected distant vision.
  • Patients with clinical symptoms of Dwitiya Patalgata Timira (Presbyopia) like Vivhal darshan (blurred vision), eye strain, headache, Suchipasham Na pashyati (difficulty in threading a needle), Sukshma cha nekshate (difficulty in seeing near objects).

排除标准

  • 1.Presbyopic patients associated with corneal degenerations, corneal ulcers, Optic disc atrophy, Glaucoma, Posterior segment disorders such as Age-Related Macular Degeneration, Non-Proliferative Diabetic Retinopathy.
  • 2.Presbyopic patients with cataract.
  • 3.Psychiatric disorders.
  • 4.Metabolic disorders like uncontrolled DM and HTN.

结局指标

主要结局

To study the effect of Krushnadya Taila Nasya and spectacle correction in symptoms of Dwitiya

时间窗: Follow up for visual assessment on | 0th day, 7th day, 14th day, 21st day, 30th day and spectacular correction on 45th day

Patalgata Timira (Presbyopia) like Suchipasham Na Pashyati, Sukshma cha nekshate.

时间窗: Follow up for visual assessment on | 0th day, 7th day, 14th day, 21st day, 30th day and spectacular correction on 45th day

次要结局

  • 1.To study the changes in near point of accommodation with RAF (Royal Air Force) rule.(2.To study the changes in the axial length of eyeball with A Scan (Amplitude scan).)

研究者

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

Dr Rashmi Vijay Deole

Dr. G. D. Pol Foundation YMT Ayurvedic Medical College

研究点 (1)

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