SPIRIT checklist - Neuroprotective Activity of Rasayana Formulation and Effect of Shigru Pallava Eye Drops on Intraocular Pressure as an Add-on Therapy Compared to the Standard of Care in Primary Open-Angle Glaucoma: Protocol for an Exploratory, Open-label, Two-arm Randomized Controlled Trial.

Glaucoma is a progressive optic neuropathy and one of the leading causes of irreversible blindness globally. This record contains the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist supporting the protocol titled “Neuroprotective Activity of Rasayana Formulation and the Effect of Shigru Pallava Eye Drops on Intraocular Pressure as an Add-on Therapy Compared to the Standard of Care in Primary Open-Angle Glaucoma: Protocol for an Exploratory, Open-label, Two-arm Randomized Controlled Trial.” Being conducted at the All India Institute of Ayurveda (AIIA), New Delhi, this two-arm, open-label, parallel-group randomized controlled trial examines the neuroprotective efficacy of an Ayurvedic Rasayana formulation and the intraocular pressure (IOP)–managing potential of topical Shigru Pallava Arka (aqueous distillate of Moringa oleifera Lam. leaves) as adjunct therapies to conventional anti-glaucoma treatment in patients diagnosed with primary open-angle glaucoma (POAG). The trial uses a 2:3 (control: intervention) allocation ratio and spans 180 days per participant.

Included in this record is the completed SPIRIT checklist, ensuring transparency and adherence to global standards for interventional trial protocols. The trial is prospectively registered with the Clinical Trial Registry of India (CTRI/2023/06/053681), contributing to the evidence base on integrated Ayurvedic approaches for managing chronic, degenerative eye conditions such as POAG.