Experimental and clinical study to evaluate the effect of Chakshushya Basti in Dry Eye syndrome
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in Tear Film Stability assessed by Tear Break-Up Time (T-BUT) before and after intervention.
研究概览
简要总结
This study is planned to assess the role of Chakshushya Basti in the management of Dry Eye Syndrome through both experimental and clinical evaluation. An experimental study will be carried out on a Benzalkonium Chloride–induced murine model to observe changes in tear film stability and corneal histopathology. The clinical arm involves an open-label randomized controlled trial comparing Chakshushya Basti with Carboxymethylcellulose sodium eye drops. Assessment will be done using Tear Break-Up Time, Schirmer’s test, OSDI scores, histological findings, and safety parameters. The study intends to provide scientific support for the therapeutic usefulness of Chakshushya Basti in Dry Eye Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 22.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Experimental Study
- •Healthy Murine model of either gender will be considered.
- •Weight- 150 to 250 g.
- •Clinical Study 1.Subject between age group of 20-50 years 2.Subjects irrespective of sex and religion 3.Subjects fit for basti karma 4.Subjects having minimum three ocular symptoms of 5.Dry eye syndrome as per diagnostic criteria 6.Subjects who are ready to sign the consent form.
排除标准
- •Experimental Study
- •Weight less than 150g and greater than 250 g.
- •Pregnant and diseased murine model.
- •Murine model that are under trial of other experiments or previous experiment Clinical Study 1.Known cases of severe ophthalmic conditions like Steven Johnsons, Chemical – Thermal Radiation burns, Idiopathic atrophy, Trachoma, Ocular pemphigoid.
- •2.Known cases of Neuroparalytic Keratitis, post-measles infection of cornea, Pterygium, Tumours, low grade bacterial/viral conjunctivitis 3.Any condition which jeo paradise the study 4.Known cases of Systemic disorder and autoimmune disorder 5.Diagnosed cases of inflammatory and infective ocular conditions.
结局指标
主要结局
Improvement in Tear Film Stability assessed by Tear Break-Up Time (T-BUT) before and after intervention.
时间窗: 1st assessment - Before Treatment (0th Day) | 2nd assessment -end of Basti treatment (10th day) | 3rd assessment- 30th day
2. Increase in Tear Secretion evaluated by Schirmer’s Test readings.
时间窗: 1st assessment - Before Treatment (0th Day) | 2nd assessment -end of Basti treatment (10th day) | 3rd assessment- 30th day
3. Histopathological improvement in corneal epithelial cell integrity and reduction in desquamation through Hematoxylin–Eosin staining (experimental arm only)
时间窗: 1st assessment - Before Treatment (0th Day) | 2nd assessment -end of Basti treatment (10th day) | 3rd assessment- 30th day
次要结局
- 1 Reduction in subjective symptoms such as dryness itching burning foreign body sensation eye strain assessed by(OSDI (Ocular Surface Disease Index) questionnaire)
研究者
Dr Prapulla K
Sri Dharmasthala Manjunatheshwara college of Ayurveda and hospital, hassan