Primary efficacy measure (Randomization to clinical recovery) and selected timeline in the two study groups (n = 134) in per protocol analysis; mean (days)± standard deviation.
*Statistically significant (P<0.05)NS Not statistically significant (P> = 0.05)a. two independent samples ‘t’ test and M-W (Mann-Whitney statisticb. Note, AYUSH plus: AYUSH 64 + Standard of Care (SOC); 134 patients qualified for primary efficacy analysis; Clinical recovery was essentially absence of COVID 19 symptoms for two successive days (with negative RT-PCR assay); See Text for detailAt this stage, we did not intend performing statistical analysis for predictor of response to treatment. However, the results of a general linear mixed effect model using the primary efficacy data as a dependent variable are shown in Table S5.4 in In an intention to treat analysis (137 participants), the mean duration (days) for clinical recovery (primary efficacy) from the randomization baseline was significantly superior in the AYUSH plus (6.42, 95% CI 5.99 to 7.59) as compared to SOC (8.33, 95% CI 7.02 to 9.87 days); difference between means was -1.90 (95% CI—3.11 to—0.70 days) (Table S5.5 in A higher proportion of patients in the AYUSH plus (69.75%) showed complete recovery as compared to SOC (52.9% patients) during the first week following randomization (P = 0.046, Chi-square statistic).The earlier recovery in the AYUSH plus group was also observed for ‘time to clinical recovery from the onset of symptom’ and this was marginally significant as compared to SOC (There was a significant reduction in serum biomarkers of COVID-19 in each of the study groups but the difference between the groups was not significant (