Design, Development and Standardization of a Unique Herbal Formulation for the Treatment of Migraine

Abstract

Migraine is a chronic neurological disorder associated with significant disability and reduced quality of life. Limitations and adverse effects of conventional pharmacotherapy have increased interest in complementary and integrative approaches. Herbal medicines, grounded in traditional systems, offer multi-target therapeutic potential with improved tolerability. A randomised controlled clinical study was conducted involving 60 migraine patients without aura. Participants were allocated to a Herbal Medicine group (HM, n=30) receiving Panchakarma (virechana) followed by a standardized polyherbal formulation for 90 days, and a Control group (CT, n=30) receiving standard symptomatic treatment with NSAIDs. Outcomes were assessed using the Cerebral Headache Questionnaire (CHQQ), Visual Analogue Scale (VAS), Migraine Disability Assessment Scale (MIDAS), Perceived Stress Scale (PSS), heart rate variability (HRV), and surface electromyography (sEMG) of the frontalis muscle. Phytochemical standardisation and antioxidant studies were also performed. Statistical analysis was conducted using repeated-measures ANOVA with Bonferroni post-hoc testing.