Efficacy of Shunthyadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana and Mridweekaadi Aschyotana (Eye Drop) with Mahatriphaladi Ghrita Pana 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
- 30
- 试验地点
- 1
- 主要终点
- Relief in Subjective and Objective criteria of Shushkaakshipaka ( Dry Eye Disease).
研究概览
简要总结
Purpose of the Research: Shushkaakshipaka (Dry Eye Disease) is a disease which is elaborately describe in Ayurveda under the heading of Sarvakshiroga. No remedical measures for the prevention and cure of this pathology prevail in the domain of modern medicine except using ocular surface lubricants, computer glasses and counselling for minimum computer use.Though lubricating drops can reduce the effect of Dry Eye , but does not break the root of pathogenesis of the disease.This limitation make us think about effective and alternative treatment of Dry Eye Disease as Ayurvedic medicines mainly focus on treating the disease from its root cause.Information on the Trial procedure and Drug: Here Group A will be given Shunthyadi Aschyotana (Eye Drop), 1 drop 4 times per day (4 hourly) along with Mahatriphaladi Ghrita Pana(15 ml) in empty stomach in the morning with Koshna Jala for 1 month. Group B will be given Mridweekaadi Aschyotana (Eye Drop), 1 drop 4 times per day (4 hourly) along with Mahatriphaladi Ghrita Pana (15ml) in empty stomach in the morning with Koshna Jala for 1month.We assure that we will prepare all formulations with as per S.O.P in the Pharmacy of I.T.R.A. Sterilized packaging of Eye Drops will be done at Indiana Opthalmics, Surendra Nagar, under aseptic conditions.Description of the Process: In present study, participants who will be clinically diagnosed and confirmed cases of Shushkaakshipaka (Dry Eye Disease) enlisted in inclusion criteria will be enrolled, minimum 30 patients and will be divided into 2 groups i.e Group A & Group B (minimum15 patients in each group) by Computer Generated Random Sampling Method. In Group A ,they will be given Shunthyadi Aschyotana (Eye Drop), 1drop 4 times per day (4 hourly) along with Mahatriphaladi Ghrita Pana (15ml) in empty stomach in the morning with Koshna Jala for 1 month. In Group B, they will be given Mridweekaadi Aschyotana (Eye Drop), 1 drop 4 times per day (4 hourly) along with Mahatriphaladi Ghrita Pana (15ml) in empty stomach in the morning with Koshna Jala for 1 month. Follow-up: After completion of the treatment patient will befollowed up for 1 month at the interval of 15 days. Side Effects: We will follow closely and keep track of any unwanted effects.We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. Results: It will be assessed on the basis of improvement in subjective and objective criteria. Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management ofShushkaakshipaka (Dry Eye Disease). Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in the age group 18-50 years irrespective of sex, caste, religion.
- •Patients having minimum three symptoms of Dry Eye Disease.
- •Patients having minimum 2 findings of below tests: i.
- •Schirmer strip wetting of between 1-15 mm in 5 minutes: Schirmer- I test.
- •The appearance of dry spot between 1-15 seconds: Fluorescein Tear Film Break Up Test (F-TBUT).
- •Mild to Severe Staining (Superficial to dense staining): Fluorescein Staining.
- •Mild to Severe Staining (Dot count 1-30): Rose Bengal Staining (Oxford scheme of scoring).
排除标准
- •1.Age less than 18 years and more than 50 years.
- •Dry Eye due to any local cause e.g., Chemical Burn, Xerosis etc.
- •Dry Eye due to systemic disease like Sjogren’s Syndrome.
- •Patients on Steroids, Oral Contraceptive Pills, Estrogen Replacement Therapy or any other medication such as Antispasmodic drugs like Atropine that may adversely affect the outcome of the study.
- •Persistent contact lens users.
- •Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy, uncontrolled Diabetes Mellitus and Hypertensive.
结局指标
主要结局
Relief in Subjective and Objective criteria of Shushkaakshipaka ( Dry Eye Disease).
时间窗: 1-2 month
次要结局
- Long-lasting effect of Ayurvedic intervention(1-2 month)