2.1 Trial design
critically ill
CRITICALLY ILL, BLIND
A randomized, controlled, single-blind, study using per protocol approach was conducted in a tertiary care hospital, St. George Hospital, Mumbai, from January to June 2021. The Principal Investigator (on field), and a team of four homoeopathic research fellows carried out the screening of all the patients and then depending on following inclusion and exclusion criteria were recruited for the study after taking written or recorded video consent, as per feasibility. The study population was then randomly divided into two arms through simple randomisation with an allocation ratio of 1:1, as per a computerized, randomised table. The participants of the Homoeopathy arm (Treatment) received homoeopathy therapy + Standard of care (SOC) as per the guidelines of Indian Council of Medical Research (ICMR), Government of India, while those of Arm the Standard of Care (SOC) received identical placebo + Standard of Care (SOC), as per the ICMR guidelines. The rationale behind designing a single-blind study was that the study was to be conducted in the ICU of the hospital, where the allopathy doctors, at no point of time, could afford restricted information on the medicines being given to the critically ill patients. For their ready reference, the records of the patients of the treatment group had the homoeopathic prescription mentioned in the treatment chart, while for the control group, placebo was mentioned. This was only possible in a single blind design.The control group received placebos, as non-medicated sugar globules (size 30) or in the form of 1 drop of dispensing alcohol diluted in 3 ml water, along with standard care.