RCTs and other clinical trial designs in Ayurveda: A review of challenges and opportunities.

J Ayurveda Integr Med

Consciousness Studies Programme, National Institute of Advanced Studies, Indian Institute of Science Campus, Bengaluru 560012, India; Manipal Academy of Higher Education, Manipal, Karnataka 576104, India. Electronic address:

Published: August 2021

AI Article Synopsis

  • There is a lack of effective clinical trial designs that thoroughly assess the efficacy of complementary and alternative medicine (CAM), particularly Ayurveda.
  • Designing Ayurveda trials is complicated due to factors like complex treatments and personalized therapy.
  • The paper critiques the standard randomized control trial (RCT) approach and advocates for more flexible trial designs, such as modified RCTs, while promoting a non-hierarchical method for generating clinical evidence.

Article Abstract

Currently, there is a paucity of clinical trial designs that comprehensively evaluate the efficacy of most complementary and alternative systems of medicine (CAMs) like Ayurveda. Several factors such as complex interventions, individualized therapy, etc., make designing Ayurveda clinical trials challenging. The prevalent randomized control trial (RCT) designs largely involve symptomatology/pathology-based recruitment and standardized interventions in carefully monitored trial environments. The present paper critically reviews the suitability of the dominant RCT model to Ayurveda and argues for newer, more sensitive trial models including modified RCTs and other clinical trial designs. It also explores the merits of a non-hierarchical approach to clinical evidence generation.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8377177PMC
http://dx.doi.org/10.1016/j.jaim.2021.06.012DOI Listing

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