ADVANCING THE CLINICAL EVALUATION OF DAIVA-VYAPASHRAYA CHIKITSA: TOWARDS AN ADAPTED RCT FRAMEWORK

Randomized controlled trials (RCTs) are widely regarded as the strongest design for estimating causal effects. However, the conventional RCT model was developed mainly around interventions that can be standardized, dosed, delivered uniformly and, where possible, blinded. Daiva-vyapashraya Chikitsa presents a different methodological situation. It includes mantra, prayer, homa, fasting and other ritual or spiritual measures whose effects may depend on the practitioner, participant, setting, belief, expectation and manner of delivery. This review examines major limitations of conventional RCT methodology when applied to Daiva-vyapashraya Chikitsa, using methodological literature on non-pharmacological and complex interventions and selected trials of spiritual and mantra-based interventions. Major concerns are intervention heterogeneity, poor standardization, inability to blind participants and providers, difficulty developing credible sham controls, treatment-fidelity problems, expectancy and contextual effects, practitioner effects, outcome selection and tension between internal and external validity. RCTs remain useful, but they should be preceded by intervention development, feasibility work and process evaluation and should use methods adapted to complex non-pharmacological interventions.