Design and amendments
MAY, RECRUITMENT
The protocol was approved by the Institutional Ethics Committee of Narayana Health City and conducted in compliance with the Declaration of Helsinki. The study protocol was approved for funding by the Department of Science and Technology, Government of India. All patients or legally authorized representatives provided written informed consent. Given the uncertainty in the recruitment and random allocation of the study subjects in chaotic hospital settings amid the pandemic, the trial was initially planned as a non-randomized clinical trial wherein an integrative yoga-based supportive care was planned to be administrated as an adjunct intervention for hospitalized patients with COVID-19. However, the protocol was amended on 14 May 2020, based on the emerging feasibility of conducting the randomization trial as emphasized by the clinicians due to the superior design of randomized vs. non-randomized trials. The study was registered at the clinical trial registry of India (CTRI/2020/09/027915, registered on 21/09/2020).