Non-randomized observational clinical study in the patients of Chronic and Refractory Migraine using Ayurvedic Treatment Protocol

The study outlined is a non-randomized observational clinical trial designed to assess the effectiveness of an Ayurvedic Treatment Protocol in patients suffering from Chronic and Refractory Migraine. The study aims to enroll 300 participants aged 11–65 years who have remained unresponsive to conventional prophylactic medications. The treatment protocol involves oral administration of specific Ayurvedic medications, including Narikel Lavana, Numax, Rasonvati, and Godanti mishran. The primary objective is to evaluate the efficacy of the Ayurvedic treatment, measured by a change in the number of headache days and Visual Analog Scale (VAS) scores. Secondary objectives include assessing the frequency, duration, and severity of migraine attacks, as well as their impact on associated symptoms using the Migraine Disability Assessment Scale (MIDAS). The study incorporates eight scheduled visits over the 360-day period, and data capturing relies on the International Headache Society (IHS) diagnostic criteria, VAS, and MIDAS to ensure comprehensive evaluation. This observational study contributes to understanding the potential benefits of Ayurvedic interventions in managing Chronic and Refractory Migraine.