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CTRI Number  CTRI/2025/03/083080 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Application of Gomaya Siddha Taila Nasya in Prathamapatalagata Timir w.s.r to Simple Myopia.  
Scientific Title of Study   Single arm clinical trail to assess the efficacy of Gomaya Siddha Taila Nasya in Prathamapatalagata Timir w.s.r to Simple Myopia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhushan Maruti Pawar 
Designation  Pg Scholar 
Affiliation  SST Ayurved College Sangamner 
Address  Dept Of Shalakyatantra,SSTAC Sangamner

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  7020334238  
Fax    
Email  bhushanpawarpb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Deshmukh 
Designation  HOD Dept Of Shalakyatantra 
Affiliation  SSTAC SANGAMNER  
Address  Dept of Shalakyatantra SSTAC SANGAMNER

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  9822262627  
Fax    
Email  ranwaraanil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Deshmukh 
Designation  HOD Dept Of Shalakyatantra 
Affiliation  SSTAC SANGAMNER  
Address  Dept of Shalakyatantra SSTAC SANGAMNER

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  9822262627  
Fax    
Email  ranwaraanil@gmail.com  
 
Source of Monetary or Material Support  
Dept of shalakya tantra SSTAC Sangamner, Ahmednagar(MH)422605, India.  
 
Primary Sponsor  
Name  Bhushan Maruti Pawar 
Address  Dept of Shalakyatantra SSTAC Sangamner Ahmednagar(MH) 422605 India. 
Type of Sponsor  Other [Own research study] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhushan Pawar  OPD Division 1st floor ,Room no -3 , Shalakyatantra OPD  SSTAC SANGAMNER
Ahmadnagar
MAHARASHTRA 
7020334238

bhushanpawarpb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee SSTAC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gomaya Siddha Taila Nasya, Reference: Sushrut Uttartantra 17/32, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 0.20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  1)Signs and symptoms of prathamapatalagata timir i.e. avyakta
rupa .
2) Signs and symptoms of simple myopia i.e blurred vision
headache, eye strain.
3) Fit for informed consent 
 
ExclusionCriteria 
Details  1) K/c/o Pathological myopia, high myopia with degenerative and
gross retinal changes.
2) Myopia associated with neighbouring structural deformities like
corneal opacity.
3) Patients suffering from any of the systemic disorders like DM,
HTN.
4) Patients who have underwent any of the refractive surgeries.
5) Patients who are contraindicated for Nasya procedure.
6) Patients with myopia having allergy to cow dung smell or not
willing to treat with gomaya medications. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Vision .  From 7-14 days after administration of nasya 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in auto refractive index of eye.  from 14-21 days after administration of nasya 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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