| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |