The efficacy of bilvadi eye drop and lauhadi guggulu in the management of computer vision syndrome - an open-label double arm randomized control trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1.Improvement in signs and symptoms of computer vision syndrome i.e. Eye strain and burning eyes.
研究概览
简要总结
**PRIMARY OBJECTIVE
To evaluate the efficacy of Bilvadi eye drops along with Lauhadi Guggulu orally on ocular symptoms of computer vision syndrome i.e. Eye strain and Burning eyes.
SECONDARY OBJECTIVE
1. To evaluate the efficacy of Bilvadi eye drops along with Lauhadi Guggulu orally on other ocular symptoms of computer vision syndrome which are Dry eyes, Blurred vision, Headache, Redness, Diplopia, Irritated eye, slow refocusing, Dizziness, Change in colour perception, Fatigue (Neck/Shoulder/Backache).
MATERIAL AND METHODOLOGY
STEP-1: The detailed study of the available description on computer vision syndrome will be studied from various Sources of Ayurvedic and Contemporary Ophthalmology.
STEP-2: The detailed review of selected drug and authentication of procured drug will be done and drug will be prepared in pharmacy of AIIA if feasible or can be procured from GMP certified pharmaceutical company (The eye drop will be prepared by distillation method which is already standardized and same will be followed).
STEP-3: Therapeutic intervention.
Setting – Shalakya Tantra OPD
Study design – Open labelled double arm randomized control clinical trial.
Groups – 2 groups
1.Group 1-Bilvadi eye drops and Lauhadi Guggulu
2.Group 2- Triphala eye drops and Saptamrit Lauha
Randomisation – Computer generated random number table
Sample size - 36 patients in each group
Assessment on – 0th day, 15th day and 30th day
Treatment period- 30 days
Follow up – 60th day
Duration of trial – 60 days
DIAGNOSIS CRITERIA:
1. Subjective parameters.
2.Objective parameter:
-Since CVS do not have any objective parameters, following tests will be carried out to rule out cases of Dry Eye Syndrome.
Schirmer’s test,
Tear film break uptime.
ASSESMENT CRITERIA : Suitable scoring criteria will be adopted
SUBJECTIVE PARAMETER
Eye strain
Burning eye
Blurred vision
Dry eyes
Headache
Redness
Diplopia
Irritated eye
Slow refocusing
Dizziness
Change in colour perception
Fatigue (Neck/Shoulder/Backache)**
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
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Minimum 3 hours exposure to any type of visual display terminal like desktop, laptop or both daily.
- •2.Computer users complaining of eye strain, burning eyes, red eyes, dry and irritated eyes, light/glare sensitivity, headache, progressive refractive changes, redness, diplopia 3.Patients having a minimum three symptoms of CVS.
排除标准
- •1.Patients not willing to participate in the study.
- •2.Patients suffering from infectious conditions of the eye like conjunctivitis, dry eye syndrome, scleritis, uveitis, glaucoma, stye, etc.
- •3.Any fundus pathology like optic atrophy, diabetic retinopathy, hypertensive retinopathy, papilledema etc.
- •4.Recent history of any surgical intervention to the eye.
- •5.Persistent contact lens users.
- •6.Patients suffering from uncontrolled systemic disease under medication.
结局指标
主要结局
1.Improvement in signs and symptoms of computer vision syndrome i.e. Eye strain and burning eyes.
时间窗: 1st day, 15th day and 30th day, 60th day.
2. The safety parameters of the trial drug will be assessed in RSBK department as per the facility available in the laboratory (physio-chemical parameters of the trial drug).
时间窗: 1st day, 15th day and 30th day, 60th day.
次要结局
- 1.Improvement in other signs and symptoms of computer vision syndrome which are Dry eyes, Blurred vision, Headache, Redness, Diplopia, Irritated eye, slow refocusing, Dizziness, Change in colour perception, Fatigue (Neck/Shoulder/Backache).(1st day, 15th day and 30th day, 60th day.)
研究者
Dr Anupriya mouriya
All India Institute of Ayurveda