Ayurvedic treatment in the rehabilitation of ischemic stroke patients in India: A randomized controlled trial (RESTORE)

BACKGROUND: The effect of Ayurvedic Rehabilitation therapy (ART) in improving the sensorimotor recovery of patients with ischemic stroke is unclear irrespective of the fact that ayurveda is a commonly practiced alternate system of medicine in India and south Asia. The trial hypothesized that ayurvedic treatment is superior to physiotherapy (PT) in recovery of ischemic stroke patients. METHODS: We performed investigator-initiated, multi-center prospective, parallel arm randomized controlled trial (RCT) with blinded outcome assessment across four comprehensive stroke centers in India. Participants were randomly assigned in a 1:1 ratio to the ART arm (intervention group) or on to the PT arm (control group). The primary outcome was sensory motor recovery of upper extremity assessed using Fugl Meyer Assessment-upper extremity (FMA-UE) and secondary outcome, a composite of functional disability, activities of daily living, postural balance and quality of life at 1- and 3-month follow-up. The safety outcomes were serious adverse events during the study duration. RESULTS: Of 403 participants screened, 140 patients were enrolled, 70 in intervention (ART) and 70 in control (PT) group. At 3 months, compared with ayurveda group, the sensory motor impairment (FMA-UE) score was significantly better in the PT group (71.97 ± 23.88 vs. 81.97 ± 24.57, p = 0.023) but after adjusting for age, stroke severity, baseline FMA-UE scale and risk factors, the group differences were not significant (p = 0.057). None of the secondary outcomes were significantly better in the ayurveda group. During the trial, no major serious adverse events were reported. CONCLUSION: This pragmatic first-ever RCT of ayurveda in stroke looked into the benefit of ayurveda treatment in first ever stroke survivors. The current intervention protocol of ART was not superior to PT in improving the sensorimotor recovery of patients with ischemic stroke. This is the first RCT of its kind.