An open label single arm clinical study on the effectiveness of agastya ghrita pana and tarpana in the management of shleshmavidagdha drishti(retinitis pigmentosa).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual acuity test revealing visual acuity improving
研究概览
简要总结
This study is a non randomized single arm clinical trial assessing the effectiveness of Agastya ghrita pana and Tarpana in the management of Shleshmavidagdha Drishti( Retinitis pigmentosa). 30 patients will be enrolled for this study for one month.This study period will be one and half year.The primary outcome measures will be reduction of night blindness, reduction of peripheral visual field loss and blurredness of vision. The secondary out come will be controls of the further deterioration of night blindness, reduced peripheral visual field and blurredness of vision. Baseline data will be assessed after the treatment and in first follow up after treatment i.e 45th and 60th day of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient ready to sign in informed consent form irrespective of sex, and religion.
- •Naktandhata (night blindness)
- •Difficulty in dark adaptation
- •Reduced field of vision 4.Blurredness of vision 5.Visual acuity test revealing reduced visual acuity.
- •6.Perimetry showing peripheral visual field defect
- •Opthalamoscopic evaluation of Fundus revealing classical triad of Retinitis pigmentosa (arteriolar attenuation, retinal bone-spicule pigmentation and waxy pallor).
- •Pictorial assessment of Retinitis pigmentosa through Fundal photograph.
排除标准
- •1.Patients having total blindness.
- •2.Patient with all kind of diabetic retinopathy and diabetic maculopathy.
- •3.Patient with pregnancy and lactating period.
结局指标
主要结局
Visual acuity test revealing visual acuity improving
时间窗: 1 month
Improvement in nightblindness
时间窗: 1 month
improvement in dark adaptation
时间窗: 1 month
Perimetry showing peripheral visual field changes
时间窗: 1 month
improvement of field of vision
时间窗: 1 month
Fundal pictorial changes
时间窗: 1 month
次要结局
- it checks the further deterioration of nightblindness, reduced peripheral visual field and blurredness of vision.(1 month)