Abstract Background: Nonproliferative diabetic retinopathy (NPDR) is a sight-threatening complication of diabetes in which current care options such as laser photocoagulation, intravitreal anti-vascular endothelial growth factor therapy, and surgery are largely palliative. Classical Ayurveda describes Pramehaja Timira as an ocular sequel of diabetes and recommends multimodality therapy for retinal and microvascular support. This study will evaluate whether adding a staged Ayurvedic protocol to conventional management can slow early retinopathy changes. Methods: This exploratory, open-label, two-arm, parallel randomized controlled trial will enroll 40 adults (40–70 years) with mild-to-moderate NPDR at two tertiary centers in New Delhi, India. Participants will be allocated 1:1 to receive either standard care alone or standard care plus an Ayurvedic protocol that includes Panchakarma therapies (such as Deepana-Pachana, Snehapana , and Virechana ), local ocular treatments (such as Takradhara, Nasya , and Vidalaka ), and internal administration of herbal decoctions (such as Vasakadi Kwatha ) to detoxify, balance doshas, and nourish retinal tissues. Treatment lasts 40 days, followed by a 40-day observation period. The primary outcome is the change in retinal edema and retinal hemorrhage level from baseline to day 40. The secondary outcomes are best-corrected distance visual acuity (logarithm of the minimum angle of resolution) and the number and area of hard or soft exudates; safety and tolerability will be monitored continuously. Analyses will follow the intention-to-treat principle, and the results will be disseminated accordingly. Discussion: The trial will provide initial controlled evidence on an integrative Ayurvedic strategy for retinal neurovascular protection. Positive findings could justify larger confirmatory studies and support a scalable, low-cost adjunct to existing care, particularly in resource-limited settings. Results and Conclusion: This study is expected to evaluate the potential of adjunct Ayurvedic therpary in improving retinal changes, visual acuity, and safety outcomes in NPDR, and to generate preliminary evidence guiding future larger clinical trials.
Thakur et al. (Thu,) studied this question.