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 [version 1; peer review: 2 approved]
Background Primary open-angle glaucoma (POAG) is a major cause of irreversible blindness worldwide, characterized by progressive optic neuropathy and loss of retinal ganglion cells (RGCs). Although lowering intraocular pressure (IOP) remains the mainstay of glaucoma management, many patients continu...
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2025-04-01
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| author | Manjusha Rajagopala Deenadayal Devarajan |
| author_facet | Manjusha Rajagopala Deenadayal Devarajan |
| author_sort | Manjusha Rajagopala |
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| description | Background Primary open-angle glaucoma (POAG) is a major cause of irreversible blindness worldwide, characterized by progressive optic neuropathy and loss of retinal ganglion cells (RGCs). Although lowering intraocular pressure (IOP) remains the mainstay of glaucoma management, many patients continue to experience vision loss, underscoring the need for adjunctive neuroprotective approaches. In Ayurveda, Rasayana therapies are believed to slow degenerative processes. One such intervention is a Rasayana Formulation (RF) comprising three oral preparations; Rasayana Churna (RC), Saptamrita Lauha (SL), and Yashada Bhasma (YB). Additionally, topical Arka (distilled extract) of Shigru Pallava (SP) has been used traditionally for glaucoma and may have an IOP-lowering effect. Methods This is an open-label, two-arm, parallel-group randomized controlled trial with a 2:3 (control: intervention) allocation ratio. A total of 50 previously or newly diagnosed POAG patients (IOP < 30 mmHg) are planned for enrollment. The control group receives the conventional standard of care alone, whereas the intervention group receives standard care plus RF (2.5 g, taken orally twice daily) and SP eye drops (1 drop, four times daily), administered for 90 days with a further 90-day follow-up. Primary outcomes include changes in optic nerve function measured by visual field indices (mean deviation (MD), pattern standard deviation (PSD), visual field index (VFI)) and retinal nerve fiber layer (RNFL) thickness, while secondary outcomes include IOP changes. Results Participant recruitment and data collection are ongoing. Final outcomes will be disseminated in peer-reviewed journals. Conclusions If shown to be effective, the combined RF and SP eye drops could enhance neuroprotection and further control IOP in POAG, thereby addressing a significant need in current glaucoma therapy. This trial may provide a foundation for larger-scale investigations into integrative treatments for glaucoma management. Trial Registration Clinical Trial Registry of India (CTRI) no. CTRI/2023/06/053681, dated 08.06.2023. Available from: https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/06/053681 Protocol Version: 3.0, dated 05.01.2023 |
| format | Article |
| id | doaj-art-8b67950e8ed24f6e890433e0cd51cda3 |
| institution | DOAJ |
| issn | 2046-1402 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | F1000 Research Ltd |
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| spelling | doaj-art-8b67950e8ed24f6e890433e0cd51cda32025-08-20T03:05:45ZengF1000 Research LtdF1000Research2046-14022025-04-011410.12688/f1000research.163722.1180119Neuroprotective 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 [version 1; peer review: 2 approved]Manjusha Rajagopala0https://orcid.org/0000-0001-9403-4612Deenadayal Devarajan1https://orcid.org/0000-0002-0263-8783Shalakya Tantra, All India Institute of Ayurveda, New Delhi, 110076, IndiaShalakya Tantra, All India Institute of Ayurveda, New Delhi, 110076, IndiaBackground Primary open-angle glaucoma (POAG) is a major cause of irreversible blindness worldwide, characterized by progressive optic neuropathy and loss of retinal ganglion cells (RGCs). Although lowering intraocular pressure (IOP) remains the mainstay of glaucoma management, many patients continue to experience vision loss, underscoring the need for adjunctive neuroprotective approaches. In Ayurveda, Rasayana therapies are believed to slow degenerative processes. One such intervention is a Rasayana Formulation (RF) comprising three oral preparations; Rasayana Churna (RC), Saptamrita Lauha (SL), and Yashada Bhasma (YB). Additionally, topical Arka (distilled extract) of Shigru Pallava (SP) has been used traditionally for glaucoma and may have an IOP-lowering effect. Methods This is an open-label, two-arm, parallel-group randomized controlled trial with a 2:3 (control: intervention) allocation ratio. A total of 50 previously or newly diagnosed POAG patients (IOP < 30 mmHg) are planned for enrollment. The control group receives the conventional standard of care alone, whereas the intervention group receives standard care plus RF (2.5 g, taken orally twice daily) and SP eye drops (1 drop, four times daily), administered for 90 days with a further 90-day follow-up. Primary outcomes include changes in optic nerve function measured by visual field indices (mean deviation (MD), pattern standard deviation (PSD), visual field index (VFI)) and retinal nerve fiber layer (RNFL) thickness, while secondary outcomes include IOP changes. Results Participant recruitment and data collection are ongoing. Final outcomes will be disseminated in peer-reviewed journals. Conclusions If shown to be effective, the combined RF and SP eye drops could enhance neuroprotection and further control IOP in POAG, thereby addressing a significant need in current glaucoma therapy. This trial may provide a foundation for larger-scale investigations into integrative treatments for glaucoma management. Trial Registration Clinical Trial Registry of India (CTRI) no. CTRI/2023/06/053681, dated 08.06.2023. Available from: https://trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2023/06/053681 Protocol Version: 3.0, dated 05.01.2023https://f1000research.com/articles/14-454/v1Ayurveda Glaucoma Intraocular Pressure Neuroprotection Protocol Rasayanaeng |
| spellingShingle | Manjusha Rajagopala Deenadayal Devarajan 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 [version 1; peer review: 2 approved] F1000Research Ayurveda Glaucoma Intraocular Pressure Neuroprotection Protocol Rasayana eng |
| title | 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 [version 1; peer review: 2 approved] |
| title_full | 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 [version 1; peer review: 2 approved] |
| title_fullStr | 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 [version 1; peer review: 2 approved] |
| title_full_unstemmed | 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 [version 1; peer review: 2 approved] |
| title_short | 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 [version 1; peer review: 2 approved] |
| title_sort | 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 version 1 peer review 2 approved |
| topic | Ayurveda Glaucoma Intraocular Pressure Neuroprotection Protocol Rasayana eng |
| url | https://f1000research.com/articles/14-454/v1 |
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