Dataset from an Exploratory Randomized Controlled Trial on the Add-on Effect of Neuroprotective Activity of Rasayana Formulation and Shigru Pallava Eye Drops on Intraocular Pressure in Primary Open-Angle Glaucoma

Glaucoma is a progressive optic neuropathy and a leading cause of irreversible blindness worldwide, often linked to elevated intraocular pressure (IOP) and characterized by gradual loss of retinal ganglion cells. This dataset accompanies the study 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.” The study is being conducted at the All India Institute of Ayurveda, New Delhi, and aims to evaluate the neuroprotective potential of an Ayurvedic Rasayana formulation along with the IOP modulating effect of topical Shigru Pallava Arka (aqueous distillate of Moringa oleifera Lam. leaves), when used as an adjunct to conventional anti-glaucoma therapy in patients with primary open-angle glaucoma (POAG). The trial adopts a two-arm, open-label, parallel-group randomized controlled design with a 2:3 allocation ratio, and a total study duration of 180 days per participant. Included in this dataset are key trial-related documents: the SPIRIT checklist, documenting adherence to international protocol reporting standards; the informed consent form used to ensure ethical and informed participation; and the patient compliance chart designed to monitor daily administration of both oral and topical interventions. The study is prospectively registered with the Clinical Trial Registry of India (CTRI/2023/06/053681) and represents an effort to generate robust evidence supporting the integration of Ayurvedic interventions into modern ophthalmic care, particularly for the management of chronic, degenerative conditions like POAG.