Clinical evaluation of Usheeradi Taila Nasya and Usheeradi Anjana in the management of Prathama Patala Gata Timira with special reference to Myopia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of treatment protocol on sign and symptoms of Prathama Patalagata Timira w.s.r.t of Myopia or changes in the unaided distance visual acuity.
研究概览
简要总结
Purpose of the research: Simple Myopia can be corrected with spectacle or contact lenses.Surgical treatment (LASIK etc) of Myopia is also becoming popular now a days but,these method for Myopic correction are not without complications besides being costly and out of reach of general population and also do not prevent myopic progression In Ayurveda many formulations are advocated for Timira for enhancement of vision Hence ,Usheeradi Nasya and Usheeradi Anjana in Prathama Patalagata Timira w.s.r.to Myopia which include ,Deepana Pachana along with Koshtashuddhi proceeding the procedures of Nasya and Anjana are selected in this study Therefore patients suffering from Myopia a clinical study has been planned entitled -Clinical evaluation of Usheeradi Taila Nasya and Usheeradi Anjana in the management of Prathama Patalagata Timira w.s.r.to Myopia-An open labelled single arm clinical trialInformation on the Trial procedure and Drug: Study Group – Single arm study group ,Deepana -Pachana by Chitrakadi Gutika 1BD 250 mg with lukewarm water after food for 7 days .Koshtashuddhi by Eranda Bhrushta Haritaki Churna 5 gms at night with lukewarm water before food for 7days .After Deepana -Pachana and Koshtashuddhi Usheeradi Taila Nasya will be given for 7 days (Marsha Nasya )6 Bindu in each nostril .After one day gap of Nasya, Usheeradi Anjana will be given for one month in Rasakriya form in 1 Vellaja dose .Along with Anjana, Chakshushya drug Saptamruta Lauha will be given for one month 250 mg in Vati form orally . We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A. Description of the Process: In present study, participants who will be clinically diagnosed and confirmed cases of Prathama Patalagata Timira (Myopia) enlisted in inclusion criteria will be enrolled. The study include single group of 30 patients with sign and symptoms of Prathama Patalagata Timira (Myopia) which is an open labelled clinical trial. Follow-up: After completion of the treatment, the patient will be followed 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: The efficacy of the therapy will be assessed on the basis of 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 of Prathama Patalagata Timira (Myopia). 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
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients complaining Avyakta Darshana/Indistinct distance vision.
- •2.Patients having a less than -6.00 dioptre will be selected for the present clinical trial.
- •3.Patients aged between 18 to 35 years.
排除标准
- •1.patients having any other ocular pathology,e.g. cataract, corneal opacity, iridocyclitis, red eye, retinal diseases, Dwitiya, Tritiya and Chaturtha Patalagata Timira will be excluded.
- •2.Patients suffering from acute rhinitis, chronic debilitating conditions, recurrent fever, recurrent headaches, hypertension, meningitis, increased intracranial pressure will be excluded.
- •3.Alcoholic patients, pregnant women will also be excluded.
- •4.Patients aged below 18 and above 35 years will be excluded.
结局指标
主要结局
Efficacy of treatment protocol on sign and symptoms of Prathama Patalagata Timira w.s.r.t of Myopia or changes in the unaided distance visual acuity.
时间窗: During the treatment period of 52 days.and follow up of 30 days
次要结局
- 1. Changes in subjective criteria.(2. Changes in axial length and K1, K2 values.)
研究者
Sonali Mahadev Sanadi
Institue of Teaching and Research in Ayurveda Jamnagar
