FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074602 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Ayurvedic Management Of Simple Myopia(Nearsightedness) 
Scientific Title of Study   A Comparative Clinical Study To Evaluate The Efficacy Of Nrupavallabha Taila Nasya And Abhijita Taila Nasya In Prathamapatalagata Timira With Special Reference 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  Dr Abhishek 
Designation  PG Scholar 
Affiliation  Govt Ayurveda Medical College,Bangalore 
Address  Department Of PG Studies In Shalakyatantra, Shalakyatantra OPD No 11, Govt Ayurveda Medical College, Dhanwantari Road, Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9483903942  
Fax    
Email  abhishekrpatilp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Syed Munawar Pasha 
Designation  HOD And Professor 
Affiliation  Govt Ayurveda Medical College, Bangalore 
Address  Department Of PG Studies In Shalakyatantra, Shalakyatantra OPD No 11, Govt Ayurveda Medical College, Dhanwantari Road, Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9886593932  
Fax    
Email  smpasha78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhishek 
Designation  PG Scholar 
Affiliation  Govt Ayurveda Medical College, Bangalore 
Address  Department Of PG Studies In Shalakyatantra, Shalakyatantra OPD No 11, Govt Ayurveda Medical College, Dhanwantari Road, Bangalore

Bangalore
KARNATAKA
560009
India 
Phone  9483903942  
Fax    
Email  abhishekrpatilp@gmail.com  
 
Source of Monetary or Material Support  
Dr Abhishek Sri jayachamarajendra Government Ayurveda And Unani Hospital Govt Ayurveda Medical College Dhanwantari road bangalore 560009 Karnataka India 
 
Primary Sponsor  
Name  Dr Abhishek 
Address  S/o Late Rajashekhar Patil Near PWD QTRS Bannappagouda Plot Yelburga-583236 Koppal district karnataka India 
Type of Sponsor  Other [Self] 
 
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 Abhishek  Sri Jayachamarajendra Ayurveda And Unani Hospital, Bangalore  Department Of PG Studies In Shalakyatantra, Shalakyatantra OPD No 11, Govt Ayurveda Medical College, Dhanwantari Road, Bangalore
Bangalore
KARNATAKA 
9483903942

abhishekrpatilp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Govt Ayurveda Medical College Bangalore  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
1Comparator ArmDrugClassical(1) Medicine Name: ABHIJITA TAILA, Reference: Bhaishajya Ratnavali Netrarogadhikara , chapter 64, verse 264-265, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: NRUPAVALLABHA TAILA, Reference: Bhaishajya Ratnavali Netrarogadhikara , chapter 64, verse 256-262, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 6(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Subjects irrespective of gender, caste and religion.
2. Subjects between the age group of 12 years to 30 years.
3. Subjects presenting with clinically established cases of simple myopia
4. Patients having -0.25 to -3.00 D of vision
 
 
ExclusionCriteria 
Details  1. Pathological myopia, High myopia with degenerative, gross retinal changes and Astigmatism.
2. Myopia associated with structural deformities like corneal opacity, keratoconus, keratoglobus.
3. Subjects who have underwent any of the refractive surgeries.
4. Subjects who are contraindicated for Nasyakarma.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Visual Acuity- Manually Done Using Snellens chart.
2. Autorefractometry 
30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Blurred Vision  30 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   11/10/2024 
Date of Study Completion (India) 22/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

         Prathama Patalagata Timira is one among the Dristigata Netrarogas. Avyakta Roopa/Darshana (Blurriness of vision) mentioned under Prathama Patalagata Timira1.

         The lakshanas of Prathama Patalagata Timira can be correlated with the signs and symptoms of Simple or developmental Myopia in Modern Ophthalmology. Simple or developmental Myopia is the most common refractive error seen in young children with prevalence rate 20-40% of population2.

        According to an article published in OPO, journal of the college of optometrists, The prevalence of myopia in 5 to 15-year-old urban children increased from 4.44% in 1999 to 21.15% in 2019. Their predictions, based on the slope of 0.8% every year (4.05% for every 5 years) indicate that the prevalence of myopia will increase to 31.89% in 2030, 40.01% in 2040 and 48.14% in 2050. Due to the generational effect (caused by the nature of the condition lasting a lifetime once developed), there will be an overall increase in myopia prevalence across all age groups of 10.53% in the next three decades (2020 to 2050)3.

        As such there is no effective treatment for myopia, only optical correction by spectacles or contact lenses to restore distant vision is advised. It’s just an aid to improve the diminished vision. Meanwhile it fails to decrease complications like glaucoma, cataract, retinal detachment and risk of posterior segment sequel of myopia. Surgical intervention is advised only in condition of stabilized myopia and complication such as dry eye and night glare are common. Moreover the cost of surgery makes it fearful and less opted procedure. Hence an alternative treatment which is safe, devoid of complication, easy to administer and cost effective is need of hour.

            In classics different shodhana kriyas like virechana, basti and nasya along with kriyakalpas4 like Tarpana , Putapaka, Aschotana and anjana etc., are explained in the treatment of Netrarogas. Nrupavallabhataila5 Nasya and Abhijitataila6 Nasya is mentioned in Bhaishajya Ratnavali, Netrarogadhikara. Hence an attempt is made to compare the efficacy of Nrupavallabhataila5 Nasya and Abhijitataila6 Nasya in the management of Prathama Patalagata Timira.


NULL HYPOTHESIS

H0 – Nrupavallabhataila Nasya is not effective in the management of Prathama Patalagata Timira with special reference to Simple Myopia.

 

ALTERNATE HYPOTHESIS

H1- Nrupavallabhataila Nasya is more effective than Abhijita Taila Nasya in the management of Prathama Patalagata Timira with special Reference to Simple Myopia.

 H2- Nrupavallabhataila Nasya is less effective than Abhijita Taila Nasya in the management of Prathama Patalagata Timira with special Reference to Simple Myopia.

 

 

 
Close