Efficacy of Darvyadi Aschyotana(Eye drop-Anubhuta)and Shunthyadi Aschyotana(Eye drop) in the management of Shushkaakshipaka(Dry eye disease)-an open labelled randomized comparative clinical trial
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
- Change in signs and symptoms of Shushkaakshipaka (Dry eye disease) during the treatment period of 1 month on 15th and 30th day.
研究概览
简要总结
Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyper osmolality, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. Hyper osmolality causes release of chemical substances like inflammatory mediators and proteases which causes histological changes like loss of goblet cells and epithelial cells. The condition gradually progresses to punctuate epitheliopathy and ultimately ocular surface damage. In Ayurveda, On the basis of signs and symptoms it can be correlated with Shushkaakshipaka. Shushkaakshipaka mentioned as Sarvagata Netraroga among all the 76 Netrarogas by Acharya Sushruta and mentioned it as Vata predominant Vyadhi. The mainstay of management of Dry Eye Disease in contemporary medicine is by instillation of artificial tear supplements, preservation of natural tears & excess mucous may be treated by acetyl cystine & in severe cases some ocular surgeries. The tear lubricants mentioned are a failure in reproducing the tears because the natural tears are a complex mixture of lipids, mucin and water. Mainly this has a local effect only and, it can’t break the root cause of pathology which often results in recurrence.Also, the main problem is the cost of these medicines. These are prescribed as lifelong therapy and many of the patients will not be in a position to afford these expensive drops. This has paved way for other medical systems, like Ayurveda, to propose experiments and offer alternative treatments for the Dry eye syndrome. Two Groups A and B will be allocated with 50 patients in each group using Computer Generated Random Sampling Method. Group A will be provided with Darvyadi Aschyotana 2 drops 4 times in a day and Group B with Shunthyadi Aschyotana with the same dosage and time interval for 30 days. Both groups will provide with Mahatriphaladi Ghrita Pana 15ml OD in empty stomach for 30 days and with Anutaila Nasya with 5ml in each nostrils at evening for 14 days.subjective and objective assessment will be done on 15th and 30th day.After completion of the treatment, the patients will be asked for follow up for 1 month at the interval of 15 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Irrespective of gender, caste, religion and socioeconomic status.
- •Patients between age group of 18 and 60 years.
- •Patients presenting with minimum 3 symptoms and at least one positive test of Dry Eye Disease.
排除标准
- •1.Dry Eye due to any local cause e.g., Chemical Burn, Xerosis.
- •2.Dry Eye due to systemic disease like Sjogren’s syndrome.
- •3.Patients on Steroids, anticholinergic drugs, Oral Contraceptive Pills, Estrogen Replacement Therapy, or any other medication such as Antispasmodic drugs may adversely affect the outcome of the study.
- •4.Persistent contact lens users.
- •5.Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy, uncontrolled Diabetes Mellitus and uncontrolled Hypertension, Pregnant ladies and lactating mothers.
结局指标
主要结局
Change in signs and symptoms of Shushkaakshipaka (Dry eye disease) during the treatment period of 1 month on 15th and 30th day.
时间窗: On 0th day ( before treatment), 15th and 30th day (after treatment)
次要结局
- Assessment of recurrence of signs and symptoms of Shushkaakshipaka(Dry eye disease)(During followup period on 15th and 30th day)
