| CTRI Number |
CTRI/2025/08/092590 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Neuroprotective Effect of Ayurveda Interventions as an Add On Therapy in Primary Open Angle Glaucoma |
|
Scientific Title of Study
|
Four Arm Randomized Controlled Trial to Evaluate the Comparative
Neuroprotective Effect of Ayurveda Interventions as an Add on Therapy in Primary Open Angle Glaucoma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Shalakya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road
New Delhi
DELHI
110076
India |
| Phone |
9901845582 |
| Fax |
|
| Email |
suvarnaramya44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjusha Rajagopala |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Shalakya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road
New Delhi
DELHI
110076
India |
| Phone |
9560788850 |
| Fax |
|
| Email |
hod-shalakya@aiia.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Ramya |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Shalakya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road
New Delhi
DELHI
110076
India |
| Phone |
9901845582 |
| Fax |
|
| Email |
suvarnaramya44@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi, India-110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi, Delhi, India. PIN:110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ramya |
All India Institute of Ayurveda |
OPD No. 110, First floor, Hospital block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road
New Delhi
DELHI |
9901845582
suvarnaramya44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H401||Open-angle glaucoma. Ayurveda Condition: ADHIMANTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Anti-glaucoma eye drops | Route: Topical eye drops.
Dose & frequency: As per guidelines of AAO-PPP-G of POAG standard care. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigrupallava eye drops, Reference: Arka Prakasha, Route: Ocular, Dosage Form: Arka, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Add on with Anti-glaucoma eye drops | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ksheerabala Taila 101 Avarty, Reference: Ashtanga Hrdaya, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Add on with Anti-Glaucoma eye drops(2) Medicine Name: Shigrupallava eye drops, Reference: Arka Prakasha, Route: Ocular, Dosage Form: Arka, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Add on with Anti-Glaucoma eye drops | | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Rasayana formulation, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Add on with Anti-Glaucoma eye drop, Shigrupallava eye drops 1 drop QID and Ksheerabala Taila 101 Avarty nasal drops 2 drops BD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Baseline IOP less than or equal to 30mmHg.
2. Newly diagnosed and untreated patients of Primary Open Angle Glaucoma.
3. Diagnosis in either or both eye with Primary Open Angle Glaucoma.
4. Glaucomatous optic disc changes with peripapillary changes having Retinal Nerve Fiber layer defects and having vertical elaborate cup disc ratio 0.5 to 0.8
|
|
| ExclusionCriteria |
| Details |
1. Visual acuity less than 6/60.
2. Corneal abnormalities that could preclude accurate IOP readings with NCT or applanation tonometry.
3. Patients of POAG who have media opacities which is sufficient to interfere with detailed ONH evaluation,
4. Advanced DR and HTN retinopathy
5. All types of Angle Closure Glaucoma, secondary and developmental glaucoma and end stage (advanced) glaucomatous optic neuropathy.
6. Inability to use topical medications.
7. Active treatment for another ophthalmic condition in either eye.
8. Any previous ocular surgeries except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (Argon laser trabeculoplasty and/or selective laser trabeculoplasty).
9. Pregnancy or lactating women.
10. Involvement in any other interventional research study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative neuro-protective effect of Ayurveda interventions as an add on therapy in terms of Perimetry (MD-Mean Deviation, PSD-Pattern Standard Deviation, VFI-Visual Field Index), OCT Retinal Nerve Fiber Thickness to standard of care for 30 and 90 days to conventional standard care patients of primary open angle glaucoma. |
0 day, 30 day, 90 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative effect of Ayurveda interventions as an add on therapy on intra ocular pressure by tonometry for 30, 60 and 90 days to conventional standard care patients of primary open angle glaucoma. |
0 day, 30 day, 60 day, 90 day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/08/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [suvarnaramya44@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Glaucoma is the second
leading cause of irreversible but preventable blindness globally, accounting
for approximately 8% of global blindness and 12.8% of blindness in India. It
ranks third after cataract and uncorrected refractive errors in India. Among
its many types, Primary Open-Angle Glaucoma (POAG) is the most prevalent form,
typically bilateral and adult onset, with a global prevalence of approximately
2.4%. POAG is characterized by elevated Intraocular Pressure (IOP), open anterior
chamber angles, progressive optic nerve damage and characteristic visual field
loss.
While reduction in IOP remains the primary and
most established treatment and modifiable risk factor for preventing disease
onset and progression, many patients continue to experience deterioration of
visual function despite effective IOP control. This highlights the potential
involvement of pressure independent mechanisms for progressive apoptosis of
Retinal Ganglion Cell (RGC) in glaucomatous optic neuro degeneration.
Hence there is increasing
interest in exploring neuroprotective strategies that go beyond IOP reduction,
including neuroprotective agents and gene therapies that preserve RGDs.
Ayurveda provides potential adjunctive option. Studies on Ayurvedic preparations
such as Shigru Pallava Arka eye drops and Rasayana therapies have
shown beneficial effect in preventing retinal damage. This study aims to assess comparative
neuroprotective effect of Ayurveda interventions as an add-on therapy compared
to standard care in management of Primary Open Angle Glaucoma (POAG). |