Efficacy of Shunthyadi Aschyotana (Eye Drop), Triphaladi Ghrita Pana (Orally) with and without Triphaladi Ghrita Nasya in the management of Dry Eye Disease (Shushkakshipaka) – An Open Labelled Randomized Comparative Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms of dry eye disease.
研究概览
简要总结
Cases of Dry Eye Disease is rising day by day due tovarious etiological factors; excessive usage of VDT (Visual Display Terminal)gadgets, prolonged usage of medications like PPIs, hypertensives,anti-depressants and increased use of contact lenses etc. Treatment ofcontemporary medicine consists, the tear lubricants mentioned are a failure in reproducing the tearsbecause the natural tears are a complex mixture of lipids, mucin and water. Itmay reduce the severity of dry eye,but it can’t break the root cause ofpathology which often results in recurrence. Other lacunas include high costingand lifelong dependency on the drugs. So, to provide good combination ofmedicine in ayurveda research is conducted on the efficacy of ShunthyadiAschyotana (Eye Drop), Triphaladi Ghrita Pana with TriphaladiGhrita Nasya. Assessment will be done based on special proforma through scoring pattern and will be analyzed statistically with the help of paired “t” test (paired and unpaired), Wilcoxon statistical tool, where > 0.05=insignificant result, <0.05=significant result and <0.001= highly significant result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Irrespective of gender, caste, religion and socio-economic status.
- •2.Patients between age group of 18 and 60 years.
- •3.Patients presenting with minimum 3 symptoms and at least two positive tests of Dry Eye Disease.
排除标准
- •1.Dry Eye due to any local cause e.g., Chemical Burn, Xerosis.
- •2.Dry Eye due to systemic disease like Sjogren’s Syndrome.
- •3.Patients on Steroids, Oral Contraceptive Pills, Estrogen Replacement Therapy, or any other medication such as Antispasmodic drugs like Atropine that may adversely affect the outcome of the study.
- •4.Persistent contact lens users.
- •5.Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy, uncontrolled Diabetes Mellitus and uncontrolled Hypertension, Pregnant ladies and lactating mothers.
结局指标
主要结局
Relief in signs and symptoms of dry eye disease.
时间窗: Relief in signs and symptoms of dry eye disease in 4-8 weeks.
次要结局
- Relief in associated complaints of dry eye disease.(Relief in associated complaints of dry eye disease in 4-8 weeks.)