A randomized controlled clinical trial to evaluate the efficacy of Suparni Varti Anjan in Pratham Patalgat Timir with special reference to simple myopia.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in Visual Acuity
研究概览
简要总结
In India, the prevalence rate of myopia in children varies between 4% and 11.5%.Refractive surgeries are not cheap, and surgical complications can result in keratitis. In Ayurvedic texts, Timir is known as’ Aushadh Sadya Vyadhi’, i.e., a medically treated disease.Many medical remedies are prescribed for Timira, as well as various herbal preparations for improving visual acuity.This is Randomized Controlled Clinical trial in which Ayurvedic formulations will be provided to 80 patients showing signs and symptoms of Pratham Patalgat Timir, which is Myopia.There will be 2 groups: trail group and control group.The trail group will receive Suparni Varti Anjana, and the control group will receive Nayansakhadi Varti Anjana.The age group taken for the study trail will be between 10 to 21 years.Ayurvedic formulations will be given on 0th 6th 11th 16th 21th 26th 30th days.Follow up on 0th 7th 15th 30th days.Total duration of the study will be 1 year and 6 months. A final conclusion will be drawn on the basis of statistical methods.
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
- 10.00 Year(s) 至 21.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Group: 10 to 21 years
- •A patient having classical symptoms of Timir will be selected.
- •Irrespective of sex, religion, education, and occupation,
- •The patient has a refractive error from -1.00 to -6.00 diopter.
排除标准
- •age group-below 10 years and above 21 years.
- •Patients with pathological myopia and high myopia.
- •Patients with severe ocular conditions like retinoblastoma, leprosy, and malignant eye disease, corneal ulcers, ocular tumour, or retinoblastoma, as well as those with degenerative and retinal changes and Patients who are taking additional ocular medications
- •A recent eye operation was performed.
- •Patients with a refractive error below -1.00 and above -6.00 diopter.
结局指标
主要结局
Improvement in Visual Acuity
时间窗: 30 days study with Follow up on 0th 7th 15th 30th days
次要结局
- Improvement in Myopic Refraction(30 days study with Follow up on 0th 7th 15th 30th days)
研究者
Dr Bhagyashri Vishnu Kumbhar
LRP Ayurvedic Medical College and Hospital Islampur