{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:09:14Z","timestamp":1772168954955,"version":"3.50.1"},"reference-count":28,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2025,4,22]],"date-time":"2025-04-22T00:00:00Z","timestamp":1745280000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"All India Institute of Ayurveda, New Delhi"}],"content-domain":{"domain":["f1000research.com"],"crossmark-restriction":false},"short-container-title":["F1000Res"],"abstract":"<ns5:p>\n                    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,\n                    <ns5:italic>Rasayana<\/ns5:italic>\n                    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 &lt; 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:\n                    <ns5:ext-link xmlns:ns6=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" ns6:href=\"https:\/\/trialsearch.who.int\/Trial2.aspx?TrialID=CTRI\/2023\/06\/053681\">https:\/\/trialsearch.who.int\/Trial2.aspx?TrialID=CTRI\/2023\/06\/053681<\/ns5:ext-link>\n                    <ns5:bold>Protocol Version:<\/ns5:bold>\n                    3.0, dated 05.01.2023\n                  <\/ns5:p>","DOI":"10.12688\/f1000research.163722.1","type":"journal-article","created":{"date-parts":[[2025,4,22]],"date-time":"2025-04-22T05:45:10Z","timestamp":1745300710000},"page":"454","update-policy":"https:\/\/doi.org\/10.12688\/f1000research.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"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"],"prefix":"10.12688","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0263-8783","authenticated-orcid":false,"given":"Deenadayal","family":"Devarajan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9403-4612","authenticated-orcid":false,"given":"Manjusha","family":"Rajagopala","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2025,4,22]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"2081-2090","DOI":"10.1016\/J.OPHTHA.2014.05.013","article-title":"Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis.","volume":"121","author":"Y Tham","year":"2014","journal-title":"Ophthalmology."},{"key":"ref2","doi-asserted-by":"publisher","first-page":"257-266","DOI":"10.4103\/0301-4738.53049","article-title":"Current concepts in the pathophysiology of glaucoma.","volume":"57","author":"R Agarwal","year":"2009","journal-title":"Indian J. Ophthalmol."},{"key":"ref3","doi-asserted-by":"publisher","first-page":"161","DOI":"10.1016\/b978-1-4377-1720-4.00143-6","article-title":"Open Angle Glaucoma.","author":"N Mahabadi","year":"February 21, 2022","journal-title":"Essence of Anesthesia Practice."},{"key":"ref4","doi-asserted-by":"publisher","first-page":"399-419","DOI":"10.1007\/978-0-387-76700-0_34\/COVER\/","article-title":"Primary open angle glaucoma.","author":"M McMenemy","year":"2010","journal-title":"The Glaucoma Book: A Practical, Evidence-Based Approach to Patient Care."},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.3389\/FMED.2021.733080","article-title":"Glaucoma Clinical Research: Trends in Treatment Strategies and Drug Development.","volume":"8","author":"L Storgaard","year":"2021","journal-title":"Front Med (Lausanne)."},{"key":"ref6","doi-asserted-by":"publisher","first-page":"89-100","DOI":"10.2174\/1874364101509010089","article-title":"Present and New Treatment Strategies in the Management of Glaucoma.","volume":"9","author":"M Kolko","year":"2015","journal-title":"Open Ophthalmol J."},{"key":"ref7","doi-asserted-by":"publisher","first-page":"1-14","DOI":"10.1155\/2020\/6138132","article-title":"Current Medical Therapy and Future Trends in the Management of Glaucoma Treatment.","volume":"2020","author":"B Cvenkel","year":"2020","journal-title":"J. Ophthalmol."},{"key":"ref8","doi-asserted-by":"publisher","first-page":"S98-S101","DOI":"10.1016\/S0039-6257(99)00027-2","article-title":"Direct and indirect approaches to neuroprotective therapy of glaucomatous optic neuropathy.","volume":"43","author":"L Levin","year":"1999","journal-title":"Surv. Ophthalmol."},{"key":"ref9","doi-asserted-by":"publisher","first-page":"1-17","DOI":"10.1016\/B978-0-12-398309-1.00002-0","article-title":"Optic nerve disease and axon pathophysiology.","volume":"105","author":"A Ghaffarieh","year":"2012","journal-title":"Int. Rev. Neurobiol."},{"key":"ref10","doi-asserted-by":"publisher","first-page":"764-772","DOI":"10.1016\/S0002-9394(02)01403-4","article-title":"Blindness and glaucoma: a comparison of patients progressing to blindness from glaucoma with patients maintaining vision.","volume":"133","author":"J Oliver","year":"2002","journal-title":"Am. J. Ophthalmol."},{"key":"ref11","doi-asserted-by":"publisher","first-page":"2099-2104","DOI":"10.1016\/S0161-6420(98)91133-2","article-title":"The probability of blindness from open-angle glaucoma.","volume":"105","author":"M Hattenhauer","year":"1998","journal-title":"Ophthalmology."},{"key":"ref12","doi-asserted-by":"publisher","first-page":"152-181","DOI":"10.1016\/J.PRETEYERES.2011.11.002","article-title":"The molecular basis of retinal ganglion cell death in glaucoma.","volume":"31","author":"M Almasieh","year":"2012","journal-title":"Prog. Retin. Eye Res."},{"key":"ref13","doi-asserted-by":"publisher","first-page":"979-986","DOI":"10.1016\/J.OPHTHA.2011.11.003","article-title":"Glaucoma 2.0: neuroprotection, neuroregeneration, neuroenhancement.","volume":"119","author":"E Chang","year":"2012","journal-title":"Ophthalmology."},{"key":"ref14","doi-asserted-by":"publisher","first-page":"78-86","DOI":"10.1097\/ICU.0B013E32834372EC","article-title":"Neuroprotection in glaucoma: recent and future directions.","volume":"22","author":"H Danesh-Meyer","year":"2011","journal-title":"Curr. Opin. Ophthalmol."},{"key":"ref15","doi-asserted-by":"publisher","first-page":"327-338","DOI":"10.1080\/02713683.2019.1663385","article-title":"Neuroprotection in Glaucoma: Towards Clinical Trials and Precision Medicine.","volume":"45","author":"T Khatib","year":"2020","journal-title":"Curr. Eye Res."},{"key":"ref16","doi-asserted-by":"publisher","first-page":"1874-1885","DOI":"10.1016\/J.OPHTHA.2018.06.017","article-title":"Oral Memantine for the Treatment of Glaucoma: Design and Results of 2 Randomized, Placebo-Controlled, Phase 3 Studies.","volume":"125","author":"R Weinreb","year":"2018","journal-title":"Ophthalmology."},{"key":"ref17","doi-asserted-by":"publisher","first-page":"CD006539","DOI":"10.1002\/14651858.CD006539.PUB4","article-title":"Neuroprotection for treatment of glaucoma in adults.","volume":"2017","author":"D Sena","year":"2017","journal-title":"Cochrane Database Syst. Rev."},{"key":"ref20","article-title":"Rasa Tarangini.","author":"S Sharma","year":"2015"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"33-38","DOI":"10.4103\/AYU.AYU_155_16","article-title":"Clinical study on primary open-angle glaucoma with Ashchyotana, Tarpana and oral medication.","volume":"38","author":"S Agrawal","year":"2017","journal-title":"Ayu."},{"key":"ref26","doi-asserted-by":"publisher","first-page":"798-806","DOI":"10.1016\/J.EXER.2008.02.008","article-title":"Retinal ganglion cell neuroprotection in a rat model of glaucoma following brimonidine, latanoprost or combined treatments.","volume":"86","author":"M Hern\u00e1ndez","year":"2008","journal-title":"Exp. Eye Res."},{"key":"ref27","first-page":"2849-2855","article-title":"Neuroprotection of retinal ganglion cells by brimonidine in rats with laser-induced chronic ocular hypertension.","volume":"42","author":"E WoldeMussie","year":"2001","journal-title":"Invest. Ophthalmol. Vis. Sci."},{"key":"ref28","doi-asserted-by":"publisher","first-page":"2625-2639","DOI":"10.1167\/IOVS.03-0566","article-title":"Efficacy and safety of memantine treatment for reduction of changes associated with experimental glaucoma in monkey, I: Functional measures.","volume":"45","author":"W Hare","year":"2004","journal-title":"Invest. Ophthalmol. Vis. Sci."},{"key":"ref29","doi-asserted-by":"publisher","first-page":"2640-2651","DOI":"10.1167\/IOVS.03-0567","article-title":"Efficacy and safety of memantine treatment for reduction of changes associated with experimental glaucoma in monkey, II: Structural measures.","volume":"45","author":"W Hare","year":"2004","journal-title":"Invest. Ophthalmol. Vis. Sci."},{"key":"ref30","doi-asserted-by":"publisher","first-page":"671-681","DOI":"10.1016\/J.AJO.2010.09.026","article-title":"A randomized trial of brimonidine versus timolol in preserving visual function: results from the Low-Pressure Glaucoma Treatment Study.","volume":"151","author":"T Krupin","year":"2011","journal-title":"Am. J. Ophthalmol."},{"key":"ref31","doi-asserted-by":"publisher","first-page":"715-716","DOI":"10.1016\/J.AJO.2011.06.015","article-title":"Clinical evidence for neuroprotection in glaucoma.","volume":"152","author":"M Cordeiro","year":"2011","journal-title":"Am. J. Ophthalmol."},{"key":"ref32","doi-asserted-by":"publisher","first-page":"756-760","DOI":"10.1126\/SCIENCE.AAL0092","article-title":"Vitamin B 3 modulates mitochondrial vulnerability and prevents glaucoma in aged mice.","volume":"355","author":"P Williams","year":"2017","journal-title":"Science."},{"key":"ref33","doi-asserted-by":"publisher","article-title":"Dataset from an Exploratory Randomized Controlled Trial on the Add-on Effect of Neuroprotective Activity of a Rasayana Formulation and Shigru Pallava Eye Drops on Intraocular Pressure in Primary Open-Angle Glaucoma.","author":"D Devarajan","DOI":"10.5281\/ZENODO.15116362"},{"key":"ref34","doi-asserted-by":"publisher","article-title":"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.","author":"D Devarajan","DOI":"10.5281\/ZENODO.15188887"}],"container-title":["F1000Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/f1000research.com\/articles\/14-454\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/f1000research.com\/articles\/14-454\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/f1000research.com\/articles\/14-454\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T20:10:11Z","timestamp":1748463011000},"score":1,"resource":{"primary":{"URL":"https:\/\/f1000research.com\/articles\/14-454\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,22]]},"references-count":28,"URL":"https:\/\/doi.org\/10.12688\/f1000research.163722.1","relation":{"has-review":[{"id-type":"doi","id":"10.5256\/f1000research.180119.r380361","asserted-by":"subject"},{"id-type":"doi","id":"10.5256\/f1000research.180119.r380360","asserted-by":"subject"},{"id-type":"doi","id":"10.5256\/f1000research.180119.r380360","asserted-by":"object"},{"id-type":"doi","id":"10.5256\/f1000research.180119.r380361","asserted-by":"object"}]},"ISSN":["2046-1402"],"issn-type":[{"value":"2046-1402","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,22]]},"assertion":[{"value":"Indexed","URL":"https:\/\/f1000research.com\/articles\/14-454\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.5256\/f1000research.180119.r380361, Naveen B.S, Sri Sri College of Ayurvedic Science and Research, Bangalore, 28 May 2025, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/14-454\/v1#referee-response-380361","order":0,"name":"referee-response-380361","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.180119.r380360, Nasreen Hanifa, Department of Shalya Tantra, Jaipur, 29 May 2025, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/14-454\/v1#referee-response-380360","order":1,"name":"referee-response-380360","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This study is funded by the All India Institute of Ayurveda, New Delhi, India \u2013 110076. (email: contact-us@aiia.gov.in). The sponsor provides funding and infrastructural support.","order":2,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}