EFFICACY OF INTEGRATED OCULAR AND SYSTEMIC AYURVEDIC THERAPY IN POST-MENOPAUSAL DRY EYE (SHUSHKAKSHIPAKA): A RANDOMIZED COMPARATIVE TRIAL.

Abstract

Background: Dry Eye Disease (DED) is a multi-factorial ocular surface disorder frequently observed in post menopausal women due to changing hormonal statuses, particularly decreased androgen and estrogen levels affecting the lacrimal and meibomian glands. In Ayurveda, this condition can be correlated with Shushkakshipaka, classified under Vata-Pittaja dominant Sarvagata netra roga. Objective: To evaluate and compare the clinical efficacy of a combined therapy using Drakshadi Ghrita Aschyotana (medicated eye drops) and internal Shatavari Ksheerapaka versus internal Shatavari Ksheerapaka alone in post menopausal women suffering from Dry Eye Disease. Methodology: A comparative clinical trial with a pre- and post-test design was conducted on a minimum of 40 post menopausal women aged 45 to 55 years fulfilling the inclusion criteria. Patients were equally divided into two groups of 20 subjects each. Group A (Trial): Treated with Drakshadi Ghrita Aschyotana (10 drops in each eye once daily) combined with internal Shatavari Ksheerapaka( 2 phala in divided doses) for 60 days. Group B (Standard): Treated with internal Shatavari Ksheerapaka (2 phala in divided doses) alone for 60 days. Assessment criteria included subjective parameters via the Ocular Surface Disease Index (OSDI) and objective parameters including Schirmer's test and Tear Break-Up Time (TBUT), evaluated across four follow-up intervals over 60 days. Results: Both groups showed statistically significant improvements from baseline to after-treatment in Schirmer’s test and TBUT parameters (p < 0.001). However, Group A (Trial) demonstrated a statistically highly significant greater improvement, with a 45.1% increase in Schirmer's test scores (compared to 34.8% in Group B) and a 45.4% increase in TBUT scores (compared to 42.2% in Group B). Overall response rates analyzed via the Mann-Whitney U Test confirmed that Group A performed significantly better overall (p < 0.001, Z = 3.71). Conclusion: The combined therapy of Drakshadi Ghrita Aschyotana and internal Shatavari Ksheerapaka is significantly more effective than internal Shatavari Ksheerapaka alone in managing Dry Eye Disease in post-menopausal women, offering synergistic benefits through localized ocular lubrication, anti-inflammatory properties, and hormonal regulation.