Efficacy of Shen Cao Gan Jiang Tang on Non-severe COVID-19 Patients: A Multicenter, Randomized, Open-Label Clinical Trial.

ABSTRACT

Background In the face of the escalating COVID-19 pandemic amid shortages of medications and vaccines, a Vietnamese herbal formula known as Shen Cao Gan Jiang Tang (SCGJT) has been put into use for non-severe COVID-19 patients. This study aims to assess its efficacy and safety. Methods A multicenter, open-label, randomized controlled trial was conducted on 300 patients with non-severe COVID-19, randomly assigned into two groups 150 receiving standard care (control group) and 150 receiving additional SCGJT for 10 days (SCGJT group). Time to resolution of symptoms, symptom severity, disease progression, time to discharge, the National Early Warning Score 2 (NEWS2) score, usage of Western drugs, time to viral clearance, and safety outcomes were continuously monitored. Results The SCGJT group exhibited faster symptom resolution (median 9 vs. 13 days) and improved symptom severity, including cough, fatigue, hypogeusia, muscle aches, nasal congestion, runny nose, and sore throat, compared to the control group. Although there was a lower rate of severe progression in the SCGJT group (0.7% vs. 4.7%), the difference was not statistically significant. The time to discharge was significantly shorter in the SCGJT group (median 7 vs. 8 days). Changes in the NEWS2 score did not show significant differences between groups. SCGJT has been demonstrated to reduce the need for symptomatic relief medications and hasten SARS-CoV-2 viral clearance. No adverse events were reported, and routine tests showed no significant differences. Conclusions SCGJT is safe and has potential clinical efficacy in non-severe COVID-19 patients. However, data regarding preventing severe progression remains inconclusive. Further studies should be conducted in light of the current state of the COVID-19 pandemic.