AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL TRIAL OF SHATADHAUTA JIVANIYA GHRITA IN THE MANAGEMENT OF SHUSHKAAKSHIPAKA
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- SELF
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- RELIEF FROM SYMPTOMS OF DRY EYE
研究概览
简要总结
In ophthalmic practice, shushkaakshipaka is a common clinical condition. Dry eye is linked to persistent eye pain and an increased risk of ocular surface disease if left untreated. Therefore, this should be treated as soon as possible to prevent additional complications.Kriyakalpa practices such as Tarpan, parishek, and others are extremely capable of managing netra roga like Shushkaakshipaka. Unfortunately, the current state of kriyakalpa procedures is not very popular with the general public due to a number of factors, including a lack of standardization, a lack of communication between institutions, a lack of communication between generations, a lack of publication, and a lack of acceptability due to the complicated methodology.
Also, factors, for example, contact focal point wear and antagonistic natural openings, for example, dry conditions, breezy circumstances or visual entrusting can intensify the side effects of dry eye
Additionally, dry eye prevalence rises with age. Dry eye syndrome affects about 45% of people over 40, according to estimates.
Patients are frequently required to make significant lifestyle adjustments, such as discontinuing the use of contact lenses, using artificial tears five to ten times per day, having plastic or collagen plugs inserted into their punctum, switching careers to reduce computer use, or using humidity swim goggles to function.
Home confinement is a result of the corona pandemic. Working from home and e-learning also means spending more time looking at screens, which is bad for eye health.
Therefore, finding a definitive, safe, and easily accessible treatment for the condition is urgent.
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 Patients presenting with the symptoms suggestive of dry eye like irritation foreign body(sandy) sensation feeling of dryness itching non-specific ocular discomfort & classical symptoms of Shushkashipaka along with altered/effected QOL.
- •2 Patients of either sex aged between 20-60 years and willing to participate in this study.
- •3 Tear film break up time less than 10 seconds.
- •4 Schirmer’s -1 test positive.
排除标准
- •1 Patients not willing to participate in this study.
- •2 Severe cases of dry eye syndrome with complications like perforated corneal ulcer Uveitis Glaucoma.
- •3 Associated with any other inflammatory & infective ocular conditions.
- •4 Systemic and Autoimmune diseases causing Dry Eye Syndrome.
结局指标
主要结局
RELIEF FROM SYMPTOMS OF DRY EYE
时间窗: 3 MONTHS
次要结局
- RELIEF FROM SYMPTOMS OF NARROWING OF PALPEBRAL APERATURE ROUGHNESS DRYNESS BLURRED VISION STUCK EYELIDS(3 MONTHS)