A Clinical Study on Ayurvedic Treatment Protocol of Shushkakshipaka (Dry Eye Syndrome) with Drakshadi Ghritapana, Vasanjana and Anutaila Nasya.

Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2013年7月3日最近更新: 2013年6月6日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 100
试验地点: 1
主要终点: Improvement in objective parameters like Schirmers -1 test, Rose Bengal staining, tear film breakup time, Fluorescein staining.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, open clinical trial. This study aims at evaluatingthe efficacy of Ayurvedic treatment protocol including Drakshadi Ghritapana,Vasanjana and Anutaila Nasya inmanagement of Shushkakshipaka i.e. Dry eye syndrome. A standard control i.e.Ecotear eye drops is being used as a comparator agent. A follow up study will be carried out for one month after completion oftreatment, subjecting to patients availability. The results will be assessed byimprovement in sign & symptoms of the disease and also based upon changesin Objective parameters.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Open Label

入排标准

年龄范围: 20.00 Year(s) 至 70.00 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 alongwith altered/effected QOL.
•2.Patients age between 20-70 years and willing to participate in this study.
•3.Tear film break up time less than 10 seconds.
•4.Schirmers -1 test positive < 10 mm 5.Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on the cornea.
•Any two criteria out of 3/4/5 are positive,diagnosis of dry eye syndrome is confirmed.

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.Inflammatory conditions like acute conjunctivitis etc.
•4.Systemic diseases causing Dry Eye Syndrome.

结局指标

主要结局

Improvement in objective parameters like Schirmers -1 test, Rose Bengal staining, tear film breakup time, Fluorescein staining.

时间窗: 30 days

次要结局

No recurrence during follow up period(1 month)

研究者

发起方

Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar

申办方类型

Research institution and hospital

研究点 (1)

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