A Randomized Controlled Clinical Trial to Compare the Effectiveness of Triphaladi Ghrita Abhyantarpana along with Spectacle Correction and Spectacle Correction alone in Dwitiya Patalgata Timira (Presbyopia)
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 changes in symptoms of Dwitiya Patalgata Timira (Presbyopia) like Vivhal Darshan(Blurring of vision), Suchipasham Na Pashyati(Patient cannot thread a needle even with great efforts), Sukshma Cha Nekshate(Unable to locate fine objects), Netrayasa(Eyestrain), Shirobhitapa(Headache)in both groups.
研究概览
简要总结
This randomized controlled clinical trial aims to compare the effectiveness of Triphaladi Ghrita Abhyantarpana along with Spectacle Correction and Spectacle Correction alone in the management of Dwitiya Patalgata Timira (Presbyopia).Presbyopia is a condition of physiological insufficiency of accommodation leading to progressive fall in near vision. Total 70 patients aged 35 - 50 years with clinical symptoms of Dwitiya Patalgata Timira will be randomly divided into two groups - the control group will receive Spectacle Correction alone, while the trial group will receive Triphaladi Ghrita Abhyantarpana once daily for 30 days during bed time along with spectacle correction .Assessment will be based on subjective parameters like near vision, threading a needle, eyestrain, headache and objective parameters such as near point of accommodation (RAF Rule) and A scan measurements. Data will be statistically analyzed to determine the effectiveness of Triphaladi Ghrita Abhyantarpana in improving near vision and reducing symptoms of presbyopia as 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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient aged between 35 to 50 years of age.
- •2.Near vision less than N 6 with normal distant vision i.e.6/6 vision.
- •3.Patients with clinical symptoms of presbyopia like Vivhal Darshan(Blurring of vision),Suchipasham na pashyati(Patient cannot thread a needle even with great efforts),Sukshma Cha Nekshate(Unable to locate fine objects),Netrayasa(Eyestrain),Shirobhitapa(Headache).
排除标准
- •1.Presbyopia associated with corneal degenerations,corneal ulcers,optic disc atrophy.
- •2.Presbyopia with cataract.
- •3.Psychiatric disorders,Metabolic disorders.
结局指标
主要结局
To study the changes in symptoms of Dwitiya Patalgata Timira (Presbyopia) like Vivhal Darshan(Blurring of vision), Suchipasham Na Pashyati(Patient cannot thread a needle even with great efforts), Sukshma Cha Nekshate(Unable to locate fine objects), Netrayasa(Eyestrain), Shirobhitapa(Headache)in both groups.
时间窗: Follow up for visual assessment will be done on 0th day, 7th day, 14th day, 30th day, 60th day spectacle correction will given on 60th day.
次要结局
- 1.To study the changes in near point of accommodation with RAF rule in both groups.(2.To study the changes in axial length of eyeball with A scan in both groups.)
研究者
Dr Deepali Rajesh Khedkar
Dr. G. D. Pol Foundation YMT Ayurvedic Medical College