A clinical study to see the effect of Ayurvedic formulation in the treatment of childrens farsightedness(Paediatric Myopia)

Phase 2

Not yet recruiting

Brief Summary: 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.*Ayurveda*gives prime importance to the eyes, as *Acharya*says, “*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 Shamak*and *Deepaniya, Chakshushya.**Amalaki*is one of the *Chakshushya*and *Rasayan*drug. *Nimba*is mentioned as a *Netrya*. *Amruta*is *Rasayani, Balya*and *Tridoshnasha*k. So oral administration of “*Shadang Kwath-Vati*” is selected for the study. *Acharya*, stated that *Shadang Kwath Vati*can be used in *Patalagata Rogas*and also acts as *Chakshushya.*

Recruitment & Eligibility

Inclusion Criteria

1)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.
2)Age- 08 to 16 years.

Exclusion Criteria

1)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.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
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

Locations (1): Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune411028
🇮🇳
Pune, MAHARASHTRA, India
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune411028
🇮🇳Pune, MAHARASHTRA, India
Shubham Shamrao Bhilawade
Principal investigator
7972909729
shubham1k98@gmail.com