Comparative efficacy of Shatavari Ghrita eye drops with Shatavari Ksheerapaka versus Triphala Ghrita eye drops with Shatavari Ksheerapaka in postmenopausal ocular surface disease: a randomized, single-blind trial.

INTRODUCTION: Dry eye disease (DED) commonly affects postmenopausal women due to hormonal changes that disrupt tear film homeostasis. In Ayurveda, this stage corresponds to Vardhakya (aging), characterized by Vata predominance and Dhatu Kshaya (tissue depletion), making DED comparable to Shushkakshipaka, a Vata-dominant ocular disorder explained in Netra Roga. This study compared the efficacy of Shatavari Ghrita eye drops and Triphala Ghrita eye drops, each administered with systemic Shatavari Ksheerapaka for mild-to-moderate postmenopausal DED. METHODS: The study was a randomized, single-blind, active-controlled superiority trial that included 120 postmenopausal women aged 45-65 years with clinically diagnosed mild-to-moderate DED. Participants were randomly allocated (1:1) into two groups (n = 60 each). Group A received Shatavari Ghrita eye drops (10 drops in both eyes) with oral Shatavari Ksheerapaka (100 mL twice daily before meals), while Group B received Triphala Ghrita (10 drops in both eyes) eye drops with the same systemic regimen. Treatment was administered for 30 days, followed by evaluations at the end of treatment and on days 45 and 60. Primary outcome measures included the Ocular Surface Disease Index (OSDI), Schirmer's test I, and tear film break-up time (TBUT). Menopause-related quality of life was assessed using the Utian Quality of Life (UQOL) questionnaire. Statistical significance was set at a p-value of < 0.05, and between-group treatment effects were reported with 95% confidence intervals (CIs). RESULTS: Both groups exhibited significant improvements from baseline in subjective symptoms and objective tear film parameters. Compared with Triphala Ghrita, Shatavari Ghrita produced significantly greater improvement in the OSDI (between-group p < 0.001), Schirmer's test 1 (between-group mean difference 7.25 mm; 95% CI 6.39-8.11; p < 0.001), and TBUT (between-group mean difference 5.10 s; 95% CI 4.49-5.71; p < 0.001). No statistically significant between-group difference was observed in UQOL scores (p = 1.000). CONCLUSION: Shatavari Ghrita eye drops, administered with systemic Shatavari Ksheerapaka, were more effective than Triphala Ghrita eye drops in improving dry eye symptoms, tear secretion, and tear film stability in postmenopausal women with mild-to-moderate DED. These findings support Shatavari Ghrita as a promising Ayurvedic therapeutic option for the management of postmenopausal dry eye disease. CLINICAL TRIAL REGISTRATION: CTRI/2023/06/054213.