A randomized controlled trial to evaluate efficacy of oral administration of Shadang Kwath Vati with spectacles in Pratham Dwitiya Patalagata Timir with reference to Paediatric Myopia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the efficacy of oral administration of Shadang Kwath Vati in the management of Pratham Dwitiya Patalagata Timir with reference to Paediatric Myopia which will be assesed on the basis of visual acuity with uncorrected and best corrected visual acuity.
研究概览
简要总结
Myopia also called as Near-sightedness or Shortsightedness is a common eye condition in which the image seen by the eye is focused prior to the retina. This produces an unfocused image on the retina which is seen by the patient as a blurred image.Ayurvedagives prime importance to the eyes, as Acharyasays, “Sarveindriyanaam Nayanam Pradhaanam”. Therefore, it is important to care of eyes and for that purpose, obtain knowledge related to eyes i.e. physiological and pathological knowledge
Timira is characterized by Avyaktam**ekshateroopam, *Vyaktamapyanimitta, Dooramnekshate.*These signs and symptoms are more similar to myopia. The signs and symptoms of myopia are blurred vision, difficult to see distant objects and visual hallucination.
According to Ayurveda Samhitas, Timira is Aushadha Sadhya Vyadhi. Haritaki is Pitta-Kapha Shamakand Deepaniya, Chakshushya.**Amalakiis one of the Chakshushyaand Rasayandrug. Nimbais mentioned as a Netrya. Amrutais Rasayani, Balyaand Tridoshnashak. So oral administration of “Shadang Kwath-Vati” is selected for the study. Acharya, stated that Shadang Kwath Vatican be used in Patalagata Rogasand also acts as Chakshushya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 8.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient Enrolled with symptoms of Prathama-Dwitiya Patalagata Timira i.e. Avyaktam- ekshateroopam (visual hallucination), Vyaktamapyanimitta (transient nature of blurriness), Dooram-n-ekshate (difficulty of distant vision) in Shalakya OPD.
- •Age- 08 to 16 years.
排除标准
- •Patient who have symptoms of Tritiya and Chaturtha Patalagata Timira will be excluded 2)Congenital type of myopia, pathological type of myopia, acquired or secondary type of myopia that occurs due to some factors or diseases i.e. post traumatic, drug induced, post keratitis.
- •will be excluded 3)Myopia associated with other ocular diseases like cataract, glaucoma,etc 4)Patient who have myopia associated with other refractive errors such as astigmatism 5)Patient who have known case of hypertension, diabetes mellitus, Rheumatic arthritis or any other arthritic conditions, rheumatic heart disease, thyroid disorder, asthma, Koch’s, HIV will be excluded 6)Patient who have active infectious diseases i.e. viral, fungal, bacterial conjunctivitis, trachoma, blepharitis.
结局指标
主要结局
To study the efficacy of oral administration of Shadang Kwath Vati in the management of Pratham Dwitiya Patalagata Timir with reference to Paediatric Myopia which will be assesed on the basis of visual acuity with uncorrected and best corrected visual acuity.
时间窗: The total duration of treatment for each patient will be 30 days with follow up on 0th, 15th and 30th day with an observational follow up on 45 th day. The effect will be assessed before and after treatment on the basis of uncorrected and best corrected visual acuity.
次要结局
- To compare the efficacy of oral administration of Shadang Kwath Vati with a spectacles in Pratham Dwitiya Patalgata Timira w.r.t. Paediatric Myopia which will be assessed on the basis of Visual Acuity under uncorrected & best corrected visual acuity.(Total duration of study is 18 Month)