| CTRI Number |
CTRI/2025/08/092954 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Abhijitha Taila Nasya vs Drusthivardhana Taila Nasya with Tila Taila Padaabhyanga in Simple Myopia |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate Efficacy of Abhijitha Taila Nasya and Drusthivardhana Taila Nasya Along with Tila Taila Padaabhyanga in the management of Prathama patalgahta 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 |
DrVidyashree Hiremath |
| Designation |
Assistant Professor |
| Affiliation |
BVVS Ayurveda Medical College and Hospital, Bagalkot |
| Address |
Shalakya Tantra room number8
Bagalkot
KARNATAKA
587101
India |
| Phone |
8904240364 |
| Fax |
|
| Email |
vidyashri30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVidyashree Hiremath |
| Designation |
Assistant Professor |
| Affiliation |
BVVS Ayurveda Medical College and Hospital, Bagalkot |
| Address |
Shalakya tantra room number 8
Bagalkot
KARNATAKA
587101
India |
| Phone |
8904240364 |
| Fax |
|
| Email |
vidyashri30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVidyashree Hiremath |
| Designation |
Assistant Professor |
| Affiliation |
BVVS Ayurveda Medical College and Hospital, Bagalkot |
| Address |
shalakya tantra room number 8
Bagalkot
KARNATAKA
587101
India |
| Phone |
8904240364 |
| Fax |
|
| Email |
vidyashri30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences 4th T Block Jayanagara Bengaluru 560 041 Karnataka INDIA |
|
|
Primary Sponsor
|
| Name |
RGUHS Bangalore |
| Address |
Rajiv Gandhi University of Health Sciences 4th T Block Jayanagara Bengaluru 560 041 Karnataka INDIA |
| Type of Sponsor |
Other [Academic Institution] |
|
|
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 Vidyashree Hiremath |
BVVS Ayurved Medical College and Hospital |
room number 8 shalakya tantra
Bagalkot
KARNATAKA |
8904240364
vidyashri30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee BVVS Ayurved Medical Coleege and Hospital Bagalkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Simple Myopia |
| Patients |
(1) ICD-10 Condition:H538||Other visual disturbances. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtanga Hrudaya , Procedure details: Purva karma Mukha abhyanga, Bhashpa Sweda
Pradhana Karma Nasya with 6 drops taila
Pashchat Karma Gandusha Dhumapana
Padabhyanga with Tila taila
Total duration 40mins/ day)
(1) Medicine Name: Abhijitha Taila, Reference: Bhaishajya Ratnavali, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtanga Hrudaya , Procedure details: Purva karma Mukha abhyanga, Bhashpa Sweda
Pradhana Karma Nasya with 6 drops taila
Pashchat Karma Gandusha Dhumapana
Padabhyanga with Tila taila
Total duration 40mins/ day)
(1) Medicine Name: Drushtivardhana Taila, Reference: Ashtanga Hrudaya , Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient presenting with features of Prathama Patalagatha Timira were selected with irrespective of sex occupation religion
2. Those who are fit for Nasya
3. Patient having age between 8 - 25 years
4. Patient having -0.25D to -5D of vision |
|
| ExclusionCriteria |
| Details |
1. Dwithiya, Thruthiya, Chatura Patalagatha Timira
2. High Myopia or Progressive Myopia
3. Congenital Myopia
4. Hypermetropia and Presbyopia
5. Those are having more than -5D of vision
6. Myopia with systemic disease like T.B, Hypertensive, DM |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in distant Vision (snellens chart reading) score
Subjective Symptom Relief Score (eye strain, headache, watering, blurred vision — assessed via a standardized questionnaire)
Patient Global Assessment of Improvement (5-point Likert scale)
|
End of treatment (Day 30) and follow-up (Day 60) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in distant Vision (snellens chart reading) score
Subjective Symptom Relief Score (eye strain, headache, watering, blurred vision — assessed via a standardized questionnaire)
Patient Global Assessment of Improvement (5-point Likert scale)
|
End of treatment (Day 30) & follow-up (Day 60) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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="0"
Months="6"
Days="15" |
|
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
|
Prathama patalagatha Timira is most common problem in this current era. Vision is the most important sense. Vision disturbance related disease occurred in Drustigatha roga
In this Covid-19 Pandemic usage of digital devices has increased because of online classes of students and employees depending on online works.
In Ayurveda, Timira causes disturbance of vision due to accumulation of doshas in different patals of eye. The vitiated vata dosha associated with Pitta/Kapha or both causes Timira’.
Acharaya Vagabhat explained Nasya Karma as a the best line of treatment in Uradwajathruga roga In Bhaishajya Rathanavali, Netraroga chapter explained that Abhijita Taila nasya helps in clearing eyesight and allivates Timira³. In Asthanga Hrudaya explained as Drushivardhana Taila Nasya helps in improve the vision. The 4 nerves in pada directly connected to eye so Padaabhyanga helps in Drustivardhana and Tila Taila is consider as best Snehana so Padaabhyanga done with Tilataila.
The prevalence of myopia is 8.5% (95% CI, 7.1-9.9%) in urban and 6.1% (95% CI, 4.5-7.7%) in rural children, with highest prevalence in urban 11-15 year age group. A significant prevalence is noted in the last decade in rural children from 4.6%.
In Present era, cost effective, easily available more efficacious and relatively free from adverse effects treatment is needed. So, here an attempt is made by this study. |