| CTRI Number |
CTRI/2025/10/096372 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of Triphaladi Ghrita Abhyantarpana along with spectacles and spectacles alone in improving age related difficulty in near vision (Presbyopia) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Compare the Effectiveness of Triphaladi Ghrita Abhyantarpana along with Spectacle Correction and Spectacle Correction alone in 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 Deepali Rajesh Khedkar |
| 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 |
8788934120 |
| Fax |
|
| Email |
khedkardeepali4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Radaye |
| Designation |
Head Of Department |
| 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 |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Radaye |
| Designation |
Head Of Department |
| 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 |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@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 Deepali Rajesh Khedkar |
| 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 Deepali Rajesh Khedkar |
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 |
8788934120
khedkardeepali4@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 | Drug | Classical | | (1) Medicine Name: Triphaladi Ghrita, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Triphaladi Ghrita Abhyantarpana will be given alongwith spectacle correction and will be compared with spectacle correction only | | 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 |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient aged between 35 to 50 years of age.
2.Near vision less than N 6 with normal distant vision i.e.6/6 vision.
3.Patients with clinical symptoms of presbyopia like Vivhal Darshan(Blurring of vision),Suchipasham na pashyati(Patient cannot thread a needle even with great efforts),Sukshma Cha Nekshate(Unable to locate fine objects),Netrayasa(Eyestrain),Shirobhitapa(Headache) |
|
| ExclusionCriteria |
| Details |
1.Presbyopia associated with corneal degenerations,corneal ulcers,optic disc atrophy.
2.Presbyopia with cataract.
3.Psychiatric disorders,Metabolic disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the changes in symptoms of Dwitiya Patalgata Timira (Presbyopia) like Vivhal Darshan(Blurring of vision), Suchipasham Na Pashyati(Patient cannot thread a needle even with great efforts), Sukshma Cha Nekshate(Unable to locate fine objects), Netrayasa(Eyestrain), Shirobhitapa(Headache)in both groups. |
Follow up for visual assessment will be done on 0th day, 7th day, 14th day, 30th day, 60th day spectacle correction will given on 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the changes in near point of accommodation with RAF rule in both groups.
2.To study the changes in axial length of eyeball with A scan in both groups. |
Follow up for visual assessment will be done on 0th day, 7th day,14th day, 30th day, 60th 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 compare the effectiveness of Triphaladi Ghrita Abhyantarpana along with Spectacle Correction and Spectacle Correction alone in the management of Dwitiya Patalgata Timira (Presbyopia).Presbyopia is a condition of physiological insufficiency of accommodation leading to progressive fall in near vision. Total 70 patients aged 35 - 50 years with clinical symptoms of Dwitiya Patalgata Timira will be randomly divided into two groups - the control group will receive Spectacle Correction alone, while the trial group will receive Triphaladi Ghrita Abhyantarpana once daily for 30 days during bed time along with spectacle correction .Assessment will be based on subjective parameters like near vision, threading a needle, eyestrain, headache and objective parameters such as near point of accommodation (RAF Rule) and A scan measurements. Data will be statistically analyzed to determine the effectiveness of Triphaladi Ghrita Abhyantarpana in improving near vision and reducing symptoms of presbyopia as compared to spectacle correction alone. |