Statistical analysis
SOC’, ’
REGRESSION, SECONDARY
There was no prior data to use for the formal calculation of a sample size. However, we considered relevant clues for a probable medium effect size which recommended 64 participants per group (type-I error = 0.05, power = 80%, The study data was entered by the designated personnel at each study site into a central database and supervised by the CRO. Data were summarized using central tendencies (mean, median), range, standard deviation, and 95% confidence interval (95% CI).Statistical tests were carried out to compare the two treatment groups as per the distribution (normality) and the type & level of measurement of the variable under consideration (like Student’s ‘t-test, Mann-Whitney non-parametric test, and Chi-square test) The result of statistical analysis was considered significant at P < 0.05 (two-sided). Both intent-to-treat (ITT) and per-protocol/completer (PP) analyses were performed for the primary efficacy analysis and some secondary measures. The ITT included all subjects who completed the randomized treatment observation till clinical recovery. The PP analysis included all subjects from the latter who were randomized within 48 hours of hospital admission and strictly adhered to other protocol requirements.Participants completing the study intervention as per protocol were considered as qualified for the primary efficacy analysis using parametric (Student’s ‘t-test) and non-parametric tests (Mann-Whitney statistic). Categorical outcomes such as AE were compared using Chi-square statistic. The primary efficacy measure was also analysed for the total number of participants at each study site and in the study. Similarly, the two study groups were also compared for several secondary efficacy measures (timelines, laboratory assays, Quality of life measures) at several time points as per protocol.A general mixed-effect linear regression model was also carried out with ‘study site’ as a random effect and ‘group intervention ‘ as a fixed effect for the primary efficacy measure. In the latter case, ‘Time from Randomization to Clinical Recovery’ (primary efficacy) was the dependent variable.Standard statistical software programs were used (GraphPad InStat Version 3.6, BMDP, IBM SPSS Version 20, and Confidence Interval Analysis, BMJ Group, London, 2003). The study arm of ‘AYUSH 64 plus SOC’ is referred to as ‘AYUSH plus ‘ and ‘SOC alone’ is referred to as ‘SOC’ in the current paper.