Effect of Ayurveda oral drug and eye drops as an add-on therapy in Glaucoma.

Neuroprotective activity of Rasayana formulation and effect of Shigru Pallava eye drops on intraocular pressure as an add-on therapy compared to standard of care in Primary Open Angle Glaucoma - an open label two arm exploratory randomised controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053681

Enrollment

Registered

2023-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H40- Glaucoma Health Condition 2: H401- Open-angle glaucoma

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed and untreated patients of POAG 2. POAG patients with an IOP 3. An open irido-corneal drainage angle on gonioscopy 4. Presence of glaucomatous visual field defects in at least one eye with corresponding damage to the optic nerve head 5. At least two reliable VF examinations in the year (Reliable VF tests are defined as exams with a false response rate < 15% and a blind spot clearly detectable in the printouts)

Exclusion criteria

Exclusion criteria: 1. Visual acuity worse than 6/36 in a study eye 2. Congenital/early childhood glaucoma 3. Secondary glaucoma (exfoliative glaucoma, pigmentary glaucoma, neovascular glaucoma) 4. Abnormalities of the anterior segment of the eye that could affect IOP assessment 5. Visually significant cataract 6. Other conditions different from glaucoma that could cause VF abnormalities (degenerative myopia, diabetic retinopathy, maculopathy, other optic nerve abnormalities that could mimic glaucoma damage) 7. Best corrected visual acuity (BCVA) +0.3 Log MAR) 8. Visual field loss mean deviation worse than â??12 dB in the better or â??15 dB in the worse eye 9. Inability to use topical medical therapy 10. Active treatment for another ophthalmic condition in either eye 11. Any previous ocular surgery except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (argon laser trabeculoplasty and/or selective laser trabeculoplasty) 12. A state of pregnancy or breast-feeding 13. Medically unfit for completion of the trial 14. Involvement in another interventional research study

Design outcomes

Primary

Measure	Time frame
1. The neuroprotective activity of Rasayana formulation (5 capsule[500mg]) 2 times a day as an add-on therapy in terms of Perimetry (MD-Mean Deviation, PSD-Pattern Standard Deviation, VFI-Visual field index) and OCT retinal nerve fibre layer (RNFL) thickness to standard of care 2. The effect of Shigru Pallava eye drops (1 drop(0.05mL)/eye) 4 times a day as an add-on therapy on intraocular pressure by tonometry to standard of careTimepoint: 0 day, 30 days, 60 days, 90 days	—

Measure

Time frame

1. The neuroprotective activity of Rasayana formulation (5 capsule[500mg]) 2 times a day as an add-on therapy in terms of Perimetry (MD-Mean Deviation, PSD-Pattern Standard Deviation, VFI-Visual field index) and OCT retinal nerve fibre layer (RNFL) thickness to standard of care 2. The effect of Shigru Pallava eye drops (1 drop(0.05mL)/eye) 4 times a day as an add-on therapy on intraocular pressure by tonometry to standard of careTimepoint: 0 day, 30 days, 60 days, 90 days

—

Countries

India

Contacts

Public ContactDeenadayal Devarajan

All India Institute of Ayurveda, New Delhi

hod-shalakya@aiia.gov.in9560788850

Outcome results