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 hypothesised that ayurvedic treatment is superior to physiotherapy in recovery of ischemic stroke patients.
Methods: We performed investigator-initiated, multi-centre prospective, parallel arm randomized, controlled trial (RCT) with blinded outcome assessment across four comprehensive stroke centres in India. Participants were randomly assigned in a 1:1 ratio to the ART arm (intervention group) or on to the conventional physiotherapy (C 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 one month and three-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 (CPT) group. At three months, compared to ayurveda group, the sensory motor impairment (FMA-UE) score was significantly better in the physiotherapy 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 ayurveda group. During the trial, no major serious adverse events were reported.
Conclusions: This pragmatic first-ever RCT of Ayurveda in stroke looked into benefit of ayurveda treatment in first ever stroke survivors. The current intervention protocol of ART was not superior to CPT in improving the sensorimotor recovery of patients with ischemic stroke. This is the first RCT of its kind. Background: Funded by Indian Stroke Clinical Trial (INSTRuCT) Network , Indian Council of Medical Research ,registered in Clinical Trial Registry- India (CTRI/2018/04/013379).