| CTRI Number |
CTRI/2025/10/096611 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
26/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Krushnadya Taila Nasya and Spectacle Correction in Dwitiya Patalgata Timira-Presbyopia. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Assess the Effectiveness of Krushnadya Taila Nasya and Spectacle Correction in the Management of Dwitiya Patalgata Timira (Presbyopia) |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Vijay Deole |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D. Pol Foundation YMT Ayurvedic Medical College |
| Address |
OPD No. 25.Shalakyatantra Department, Ground Floor, Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7798455583 |
| Fax |
|
| Email |
deolerashmi162@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Magar |
| Designation |
Professor |
| Affiliation |
Dr. G. D. Pol Foundation YMT Ayurvedic Medical College |
| Address |
OPD No. 25.Shalakyatantra Department, Ground Floor, Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987335024 |
| Fax |
|
| Email |
sunitamagar66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Magar |
| Designation |
Professor |
| Affiliation |
Dr. G. D. Pol Foundation YMT Ayurvedic Medical College |
| Address |
OPD No. 25.Shalakyatantra Department, Ground Floor, Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987335024 |
| Fax |
|
| Email |
sunitamagar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Rashmi Vijay Deole |
| Address |
OPD No. 25.Shalakyatantra Department, Ground Floor, Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai |
| 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 Rashmi Vijay Deole |
Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital |
OPD No. 25.Shalakyatantra Department, Ground Floor, Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital PG Institute. Institutional Area Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
7798455583
deolerashmi162@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Dr G D Pol Foundation YMT Ayurvedic medical college and charitable hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H524||Presbyopia. Ayurveda Condition: DVITIYA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hrudaya Sutrasthana chapter 20,shlok 17., Procedure details: Nasya procedure will be carried out in three stages. In Purva Karma,informed consent will be obtained,the patient will be made to lie in a supine position, followed by local Snehana on face using Tila Taila and Nadi Swedana .In Pradhan Karma, the patient will lie with a slightly extended neck, and Marsha Nasya with 8 Drops of Krushnadya Taila will be instilled alternately in each nostril using a dropper, followed by gentle upward facial massage.In Paschat Karma, the patient is asked to expel excess oil by spitting if it reaches the throat and perform gargling with lukewarm water.)
(1) Medicine Name: Krushnadya Taila, Reference: Yogratnakar Netrarogadhikar 1/378, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Spectacle Correction | Presbyopia will be corrected by refraction and Spectacle correction will be given. |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients age between 35 to 55 years of age.
2. Patients of either gender.
3. Patients having near vision less than N6 with best corrected distant vision.
4. Patients with clinical symptoms of Dwitiya Patalgata Timira (Presbyopia) like Vivhal darshan (blurred vision), eye strain, headache, Suchipasham Na pashyati (difficulty in threading a needle), Sukshma cha nekshate (difficulty in seeing near objects). |
|
| ExclusionCriteria |
| Details |
1.Presbyopic patients associated with corneal degenerations, corneal ulcers, Optic disc atrophy, Glaucoma, Posterior segment disorders such as Age-Related Macular Degeneration, Non-Proliferative Diabetic Retinopathy.
2.Presbyopic patients with cataract.
3.Psychiatric disorders.
4.Metabolic disorders like uncontrolled DM and HTN.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of Krushnadya Taila Nasya and spectacle correction in symptoms of Dwitiya
Patalgata Timira (Presbyopia) like Suchipasham Na Pashyati, Sukshma cha nekshate. |
Follow up for visual assessment on
0th day, 7th day, 14th day, 21st day, 30th day and spectacular correction on 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the changes in near point of accommodation with RAF (Royal Air Force) rule.
2.To study the changes in the axial length of eyeball with A Scan (Amplitude scan).
3.To compare the effect of Krushnadya Taila Nasya and spectacle correction with control group
having Spectacle correction only. |
Follow up for visual assessment on
0th day, 7th day, 14th day, 21st day, 30th day and spectacular correction on 45th day
|
|
|
Target Sample Size
|
Total Sample Size="70"
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)
|
01/01/2026 |
| 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
|
This randomized controlled clinical trial aims to evaluate the effectiveness of Krushnadya Taila Nasya along with spectacle correction in the management of Dwitiya Patalgata Timira (Presbyopia).Presbyopia is a common age related condition causing difficulty in near vision due to loss of accommodation. Total 70 patients aged 35-55 years with clinical features of Dwitiya Patalgata Timira will be randomly divided into two groups : the control group will receive spectacle correction only, while the trial group will receive Krushnadya Taila Nasya once daily for 30 days along with spectacle correction. Assessment will be based on subjective parameters like near vision, needle threading, eye strain and headache and objective parameters such as Near Point of Accommodation (RAF rule) and A-Scan measurements. Data will be statistically analysed to determine the efficacy of Krushnadya Taila Nasya in improving near vision and reducing presbyopic symptoms compared to spectacle correction alone. |