Efficacy Of Chandrodaya Varti Anjana Along With Timirahara Lauha Orally In The Management Of Timira - Immature Senile Cataract - A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Improvement of Avyakta Darshana (blurring of vision) in terms of Visual acuity
研究概览
简要总结
Cataract has been documented to be the most significant cause of bilateral blindness, both in India as well as on a global scale. Aging is the most common aetiological factor contributing to the disease cataract. The pathophysiology behind senile cataract is yet to be fully understood. Multiple mechanism contributes to loss of normal transparency in senile cataract. There is no universally accepted pharmacological agent that can either reverse or inhibit the progression of cataract.
Globally, at least 2.2 billion people have a near or distance vision impairment. In at least 1 billion- almost half of these cases, vision impairment could have been prevented or has yet to be addressed. The leading cause of visual impairment and blindness are uncorrected refractive errors (88.4 million) and cataract (94 million).
OBJECTIVE OF RESEARCH
Primary Objective:
§ To evaluate the efficacy of local application of Chandrodaya Varti (approx. 60mg - BD for 45 days) along with Timirhara Lauha orally (500mg-BD) for 45 days in management of Timira- symptom i.e*., Avyakta Darshana* (blurring of vision) in terms of Visual acuity.
Secondary Objective:
§ To evaluate the efficacy of local application of Chandrodaya Varti (approx. 60mg-BD for 45 days) along with Timirhara Lauha (500mg-BD for 45 days) in management of Timira on other associated symptoms like glare, diplopia, black spots in front of eyes, difficulty in day and night vision, headache.
§ To study the pharmacognostical and physico-chemical properties of Chandrodaya Varti Anjana and Timirahara Lauha.
§ To study the acute eye irritation/corrosive effect of Chandrodaya Varti Anjana if feasible.
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
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 patients having signs and symptoms of immature senile cataract described as per ayurvedic and contemporary texts 2 patients willing to take ayurvedic treatment 3 Visual Acuity better than or equal to 6/60 Snellen chart/ Log MAR 1 4 Senile immature cataract.
排除标准
- •1 Congenital cataract,Traumatic cataract 2 Patients suffering from inflammatory and infectious disease of eyeball and its appendages 3 Hyper-mature and mature cataract 4 Patients is under / having history of using any cataract inducing medications like corticosteroids, phenothiazines and miotics drugs etc 5 History of any surgical intervention to eye 6 Patients having other systemic diseases or metabolic disorders or ocular diseases such as uncontrolled D.M., Diabetic Retinopathy, Macular Degeneration, Retinitis Pigmentosa and any other illness necessitating long term treatment or under any kind of immunosuppressive therapy.
结局指标
主要结局
Improvement of Avyakta Darshana (blurring of vision) in terms of Visual acuity
时间窗: 90 days
次要结局
- Assessment of Ocular toxicity of Chandodaya Varti Anjana(improvement of other associated symptoms like glare, diplopia, black spots in front of eyes, difficulty in day and night vision, headache)
研究者
Dr Sangita Shekhaliya
All India Institute Of Ayurveda