A randomized comparative clinical trial on the efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose eye drop each combined with Jeevaniya Taila Nasya in the management of Shushkakshipaka with special reference to Computer Vision Syndrome
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in Ocular Surface Disease Index (OSDI) score in Shushkakshipaka (Computer Vision Syndrome).
研究概览
简要总结
Computer Vision Syndrome CVS, also known as Digital Eye Strain, is an emerging public health concern caused by prolonged use or extended exposure to video display terminals VDTs including devices such as computers, tablets, e-readers, and mobile phones. Computer Vision Syndrome presents with a spectrum of visual, ocular, and extraocular symptoms with dry eye being a central component. In Ayurveda, this condition closely resembles Shushkakshipaka, a disease described in classical texts as Sarvagata Netraroga diseases affecting all regions of the eye.
Allopathy presents limited interventions and often comes with long-term drawbacks. Ayurveda, with its holistic approach, offers promising solutions through systemic and local therapies. This randomized comparative clinical trial is designed to evaluate the efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose CMC Eye Drops, each in combination with Jeevaniya Taila Nasya, in the management of Shushkakshipaka Computer Vision Syndrome. The study aims to provide a cost-effective, safe, and efficient alternative for managing Computer Vision Syndrome CVS symptoms through integrative Ayurvedic interventions.
HYPOTHESIS
Null Hypothesis H0 There is no difference in efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose Eye Drop, each combined with Jeevaniya Taila Nasya, in the management of Shushkakshipaka with special reference to Computer Vision Syndrome.
Alternative Hypothesis H1 There is a difference in efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose Eye Drop, each combined with Jeevaniya Taila Nasya, in the management of Shushkakshipaka with special reference to Computer Vision Syndrome.
AIM AND OBJECTIVES
AIM To compare the efficacy of Saindhavadya Anjana and Carboxy Methyl Cellulose Eye Drop, each combined with Jeevaniya Taila Nasya, in the management of Shushkakshipaka with special reference to Computer Vision Syndrome.
OBJECTIVES
- To evaluate the efficacy of Saindhavadya Anjana combined with Jeevaniya Taila Nasya in the management of Shushkakshipaka with special reference to Computer Vision Syndrome.
- To evaluate the efficacy of Carboxy Methyl Cellulose Eye Drop combined with Jeevaniya Taila Nasya in the management of Shushkakshipaka with special reference to Computer Vision Syndrome.
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
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between 18 to 55 years of age and willing to participate in this study through written consent are recruited.
- •2.Patients utilizing a Computer or Video Display Terminals VDTs for a minimum of two hours each day and presenting with minimum three of clinical features of Shushkakshipaka Computer Vision Syndrome such as Kunita Vartma Photophobia, Avila Darsana Blurring of vision, Gharsa Foreign body sensation, Toda Asthenopia, Ushnadaha Burning sensation, Vishushkatva Dryness of eyes, Raga Conjunctival congestion.
- •3.Patients with OSDI score from Mild 13 to 22 to Moderate 23 to 32 will be included in the study.
排除标准
- •1.Individuals under the age of 18 and those over the age of 55 are not included in the study.
- •2.Cases that are complicated by Acute or Chronic infection of Conjunctiva, Eyelid, Cornea, Dacryocystitis, Lagophthalmos, Sjogrens Syndrome.
- •3.Pregnant and lactating women are excluded in the study.
- •4.Patients with severe systemic illnesses that could hamper the trial in between are excluded.
- •5.Severe patients of Computer Vision Syndrome with complications like Corneal Ulcer.
结局指标
主要结局
Changes in Ocular Surface Disease Index (OSDI) score in Shushkakshipaka (Computer Vision Syndrome).
时间窗: Improvement in OSDI score from baseline to the end of 33 days treatment period, indicating relief in Shushkakshipaka (Computer Vision Syndrome).
次要结局
- Changes in Schirmer-1 reading, Tear Film Break-Up Time, Ocular Surface Staining grading and subjective Ocular symptoms grading in Shushkakshipaka (Computer Vision Syndrome).(Improvement in Schirmer-1 reading, Tear Film Break-Up Time, Ocular Surface Staining grading and subjective Ocular symptoms grading from baseline to the end of 33 days treatment period, indicating relief in Shushkakshipaka (Computer Vision Syndrome).)
研究者
Dr Mahima Choudhary
National Institute of Ayurveda Deemed to be University (De-novo) Jaipur