Oral Liushen Pill for Patients with Covid-19 : A prospective, randomized, controlled trial

Abstract Objective To analyze the efficacy and safety of Liushen Pill combined with basic treatment on patients with COVID-19.Methods One-hundred-eighty-one patients hospitalized with COVID-19, classified as asymptomatic, mild type, were randomly separated into the experimental (n=91) and control (n=90) groups. The control group was given placebo (Maizao decoction), while the experimental group was given Maizao decoction and Liushen pill, in addition to standard care. The negative conversion rate of nucleic acid (Day 7), hospital discharge rate (Day 8, 10, 14), symptom disappearance rate (Day 3, 5, 7), inflammatory cytokines and adverse events between the two groups were compared. Results The negative viral conversion rate in the experimental group was significantly higher than that in the control group (48.35% vs 31.11%, P＜0.05). Subgroup analysis showed a similar significant trend when the Ct value was ≤ 30 at baseline. After 10 days, the hospital discharge rate was significantly higher in the experimental than the control group (69.23% vs 53.33%, P＜0.05). After 3 days of medication, the headache symptoms significantly disappeared in the experimental group (88.57%) compared to the control group (63.33%) (P＜0.05). After 5 days, symptom disappearance rate of headache in the experimental group (97.14%) was still significantly higher than that in the control group (80.00%) (P＜0.05), as was the symptom disappearance rate of cough (82.65% vs 58.93%, P＜0.01). After treatment, the PCT level was significantly lower in the experimental than the control group (0.09±0.00 ng/L vs 0.14±0.05 ng/L) (P＜0.05). There were no significant between-groups differences in clinical safety test indexes.Conclusion Early intervention with Liushen Pill could improve the symptoms of cough and headache, and increase negative viral conversion and discharge rate.Trial registration Chinese Clinical Trial Registry, No. ChiCTR2200058859. Registered on April 18, 2022. https://www.chictr.org.cn/edit.aspx?pid=166975&htm=4