Randomized control Clinical trial on efficacy of Ushiradi Taila Netrabhyanga in comparison with Hydroxypropyl Methylcellulose eye gel in the management of Shushkashipaka with special reference to dry eye disease
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the changes in subjective symptoms of Dry eye Disease
研究概览
简要总结
Patients with confirmed diagnosis of Shushkashipaka(dry eye disease)will be informed about the trial and written consent will be taken. Interventions to both the groups will be given and assessment will be done based on which stastistical analysis will be made. Observations and results will be done based on statistical analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having symptoms of Shushkaakshipaka, patients of age group 40 years to 60 years, are randomly selected to maintain homogeneity.
- •Patients suffering from DED are selected irrespective of gender or socioeconomic status.
- •Patients with scores less than 15 mm on Schirmer’s test.
排除标准
- •Patients with age groups below 40 years and above 60 years are excluded.
- •Patients suffering from ophthalmic infective diseases are excluded.
- •Patients with other major ophthalmic diseases like glaucoma, retinal abnormality are excluded.
结局指标
主要结局
To assess the changes in subjective symptoms of Dry eye Disease
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
(Shushkakshipaka) in group A and group B.
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
2. To assess the pre and post study changes in Schirmer’s test, BUT test and Rose
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
Bengal Test in group A and group B.
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
To study the efficacy of Ushiradi taila netrabhyanga and HPMC gel in dry eye
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
disease.
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
2. To study ushiradi taila in detail.
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
3. To study netrabhyanga in detail and to prepare SOP of it.
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
4. To study probable mode of action of netrabhyanga in detail.
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
5. To study HPMC Gel and its properties.
时间窗: at baseline, 7th day, 14th day, 21st day, 28th day, 42nd day
次要结局
- To study the efficacy of Ushiradi taila netrabhyanga and HPMC gel in dry eye(disease.)
研究者
Dr Nikhil Naganath Mali
Ayurved Vidya Prasarak Mandal’s Ayurved Mahavidyalaya, Sion