Single arm clinical trail to assess the efficacy of Gomaya Siddha Taila Nasya in Prathamapatalagata Timir w.s.r to Simple Myopia.
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Bhushan Maruti Pawar
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Improvement in Vision .
Overview
Brief Summary
The importance of eye is described in Ayurveda by quoting eye as the most important of all sense organs: “Sarvendriyanam madhye nayanasya pradhanatvath”- eyes hold special status among all the sense organs.As quoted in Ashtanga Hridaya, sincere efforts should be made by every individual to preserve his / her vision till the last breath of life; because, for an individual who is blind, day and night are the same and this beautiful world is of no use to him/her even if he possesses a lot of wealth!
In Ayurveda, clinical features related to visual disturbances are generally seen in Drishtigata Rogas. Prathamapatalagata Timira is one of them described as an ocular pathology in Ayurveda, is nothing but errors of refraction. So, a detailed conceptual and clinical study is needed to explore the disease’s aetiopathogenesis and symptomatology in Ayurveda using modern parameters. Myopia, a form of refractive error where the distant vision is compromised, embraces a large section of the Present-day population. Myopia and other refractive errors account for about 7% of the causes of blindness in India.Symptoms of Simple Myopia includes blurred vision, distorted vision, eye strain when performing near work like studying or driving, headache usually in the evening due to straining and squinting eyes when trying to read far away objects. Refractive power can be neutralized by placing in front of the eye a concave spherical lens in form of spectacles or contact lens, which diverge the rays. In Ayurveda it is correlated to Timira the word Timira indicates the darkness. Conditions with gradual loss of vision leading to blindness are considered as Timira. As per Acharya Sushrata Timira, Kacha and Linganasha are three stages of the same disease and in the last stage of these will be complete blindness. Timira too is explained in stages, where in the Doshas vitiate the patalas or layers of eyes which are situated one behind the other. When the first Patala i.e. outer most Patala is affected. It is mild in nature and gradually inner Patalas when gets affected can lead to disorders of serious nature to eyes. Prathama patalgata timira, is when the vitiated doshas, move or gets sthansanshrya towards eyes, first reach the Prathama patala of the eye. The patient will have blurred vision. This is explained as Avyakta darshana by Acharya Sushruta.Animittha Avyakta roop darshana by Acharya Vagbhatta and kadachith roop darshana by Acharya Madhava5 if untreated will encroach the second patala. Treatment of this includes Ghurtapana, Nasya, Virechana, Basti Karma, Kriyakalpa like Anjana , siravyedha etc. In this study Navan nasya of Gomaya Siddha Taila is taken up.
Nasya karma enhances the activity of sense organ and prevent the disease of Urdhwanga. Sushrutacharya included Netraroga in Shalakya tanntra. The nasolacrimal duct connects the nose to the eye directly, i.e., infection of the nose or sinus can pass to the eye or excess lacrimation drain to the nose. Nasya is mentioned in many Netra roga according to Ayurveda eg. Abhishyanda, Adhimantha, pittavardhak Drushti, and Timir with different drugs. A good number of Nasya preparations are also described for Timira, because the nose is the gateway of drug administration in the case of Urdhwajatrugata rogas, and Nasya is the only procedure that directly influences all the Indriyas.
NEED OF STUDY :
The prevalence of myopia in the population-based studies varied
between 3.6% and 36.5%, whereas the school-based, and the hospital- based studies had a prevalence rate of 7.5% to 8.6%, and 9%, respectively.
According to sight saving review (1979) myopia is the 4th major cause of visual loss after cataract, glaucoma, and senile macular degeneration.
Sufficient studies have already been carried out on Timira with reference to myopia and its management with Tarpana, Anjana, Eye exercise, Vidhakarma at various institutes including the Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar and other institutes, to know the efficacy of above kriyakalpas . But there is not enough work done related to Nasya .
Spectacles are used to correct the refractive error but it neither cures nor prevents the progression of the pathology. Though Laser and surgical measures are in practice they are not without complications. The cost of the surgery is also out of reach of common man.
Gomaya Siddha Taila Nasya is indicated for treatment of Timira according to Acharya Sushruta, Acharya Vangasena, Acharya Chakradatta.Nasya is simple procedure, non-invasive, cost effective with no known side effects is taken up for this study.
Considering the above factors the present study is initiated to assess the efficacy of Gomaya Siddha Taila nasya in Prathamapatalagata Timir w.s.r. to Simple Myopia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 39.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Signs and symptoms of prathamapatalagata timir i.e. avyakta rupa .
- •Signs and symptoms of simple myopia i.e blurred vision headache, eye strain.
- •Fit for informed consent.
Exclusion Criteria
- •K/c/o Pathological myopia, high myopia with degenerative and gross retinal changes.
- •Patients suffering from any of the systemic disorders like DM, HTN.
- •Patients who have underwent any of the refractive surgeries.
- •Patients who are contraindicated for Nasya procedure.
- •Patients with myopia having allergy to cow dung smell or not willing to treat with gomaya medications.
Outcomes
Primary Outcomes
Improvement in Vision .
Time Frame: From 7-14 days after administration of nasya
Secondary Outcomes
- Improvement in auto refractive index of eye.(from 14-21 days after administration of nasya)
Investigators
Bhushan Maruti Pawar
SST Ayurved College Sangamner