| 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
|
|
|
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
|
|
|
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 | Comparator Arm | Drug | Classical | | (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: | | 2 | Intervention Arm | Drug | Classical | | (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.
|