Topical Ayurvedic Intervention (Yastimadhwadi Ashchyotana) in the Management of Computer Vision Syndrome Associated Dry Eye: A Pilot Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change from baseline in subjective dry eye symptoms(DESS) and Ocular Surface Disease
研究概览
简要总结
This study will be conducted to assess the efficacy, safety and tolerability of a topical Ayurvedic ophthalmic intervention (Yastimadhwadi Ashchyotana) in the treatment of Computer Vision Syndrome (CVS) associated dry eye compared to artificial tear eye drops (Carboxy methyl cellulose) 0.5%. the challenges of conventional artificial eye drops, the quest for safe and effective topical preparations for dry eye other than conventional ones has increased. Various topical therapeutic preparations in different forms are described in Ayurveda to treat dry eye conditions but are not in practical use. There is an urgent need to evaluate and validate the efficacy and safety of those preparations on scientific parameters so that an alternative ayurvedic topical ophthalmic preparation could be developed for dry eye conditions. with the help of selective inclusion and exclusion criteria total 30 patient going to be enrolled for the study in also with 10 patient to compensate for dropout . 2 groups will be made in that group 1 is for ayurvedic intervention group and group 2 is control group . study duration will be 60 days .
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
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients of either gender aged between 12 to 65 years.
- •b) Patients having minimum three symptoms of Computer Vision Syndrome (Eye strain and fatigue, Headache, blurred vision, dry and irritated eyes, double vision, redness of eyes, burning eyes, excessive tearing and photophobia).
- •c) Minimum 3 hours daily exposure to any type of Video Display Terminals (VDT) for 1 year.
- •d) Patients able and willing to provide written informed consent.
- •e) No expectation that subject will be moving out of the area of the study center during the study period.
排除标准
- •a) Known allergy to any eye drops.
- •b) Ocular therapies other than artificial tears.
- •c) Patients having current ocular infection, laser in situ keratomileusis (LASIK) in the last 3 months, active ocular allergy, contact lens wearer, Meibomian gland dysfunction (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results.
- •d) Patients having herpetic eye disease, diabetes, liver diseases, HIV and Hepatitis B and C.
- •e) Systemic (tetracycline’s and corticosteroids) or topical medications (other than artificial tear supplements) that could affect tear film or meibomian gland functions will be discontinued prior to intervention.
- •However, patients will be instructed not to use artificial tear preparations, 2 hours prior to testing.
- •g) Uncontrolled systemic disease.
- •h) Hypersensitivity or intolerance to study drugs (intervention or control).
- •i) Active participation in any type of intervention study.
结局指标
主要结局
Mean change from baseline in subjective dry eye symptoms(DESS) and Ocular Surface Disease
时间窗: day0 day15 day30 day45 day60
Index (OSDI) score at the follow-up and end of treatment visit.
时间窗: day0 day15 day30 day45 day60
次要结局
- Mean change in Schirmer test value (tear production) at the follow-up & end of treatment(visit compared with baseline.)
研究者
Dr Bhanu Ahirwar
Government Ayurvedic Collage and Hospital Kadamkuan Patna Bihar