An open labeled randomised comparative clinical study to evaluate the efficacy of Durva Ghrita eye drops and Rajanidaru eye drops combined with Triphaladi compound orally in Shushkakshipaka (Dry eye syndrome) and in-silico study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in the clinical features i.e. foreign body sensation, dryness in the eyes, increase in Schirmer’s test result and Tear Break Up Time (BUT)
研究概览
简要总结
This study is an open label double arm randomised clinical trial comparing the efficacy of Durva ghrita eye drops(1 drop in each eye QID or as per requirement) and Rajanidaaru eye drops(1 drop in each eye QID or as per requirement) combined with Triphaladi compound(6 gm bd) orally for 42 days in patients of shuskakshipaaka (Dry eye syndrome) along with In-silico study .The trial will be conducted in All India institute of Ayurveda New Delhi.The primary outcome measures will be reduction in th clinical features i.e, foreign body sensation,dryness in the eyes,increase in schirmer test results and tear break-up time and the secondary outcomes will be overall improvement in rest of other symptoms and quality of life related to ocular health.
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between the ages of 30 to 70 years regardless of sex.
- •The patient is capable and willing to take part in the research.
- •Individuals who exhibit the text described lakshana of Shushkakshipaka and signs and symptoms of dry eye illness.
排除标准
- •Severe cases of dry eye disease accompanied by uveitis, glaucoma and corneal ulcers, among other consequences.
- •Allergies and inflammations, such as giant papillary conjunctivitis, vernal keratoconjunctivitis and acute conjunctivitis.
- •Patients suffering from major systemic illness necessitating long term treatment ex.
- •Psycho epileptic drug users etc.
- •History of hypersensitivity of the trial drug or any of its ingredients.
结局指标
主要结局
Reduction in the clinical features i.e. foreign body sensation, dryness in the eyes, increase in Schirmer’s test result and Tear Break Up Time (BUT)
时间窗: Evaluation of the patient during the treatment on 0th, 30th and 45th day
次要结局
- Overall improvement in the rest other symptoms & quality of life related to ocular health will be assessed according to OSDI Chart.(Evaluation of the patient during the treatment on 0th, 30th and 45th day)
研究者
Vaidehi Dutt
All India Institute of Ayurveda