PDF(Pubmed)
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.
摘要：
背景面对不断升级的COVID-19大流行，因为药物和疫苗短缺，一种名为“深草干姜汤”（SCGJT）的越南草药配方已用于非重症COVID-19患者。本研究旨在评估其有效性和安全性。方法多中心，开放标签，我们对300例非重度COVID-19患者进行了随机对照试验,随机分为两组:150例接受标准治疗(对照组)和150例接受额外SCGJT治疗10天(SCGJT组).是时候解决症状了，症状严重程度,疾病进展,放电时间，国家预警评分2（NEWS2）评分，使用西药，病毒清除时间，并对安全性结果进行持续监测.结果SCGJT组症状消退更快（中位数：9vs.13天）并改善症状严重程度，包括咳嗽,疲劳,伪善,肌肉疼痛,鼻塞,流鼻涕,喉咙痛,与对照组相比。尽管SCGJT组的严重进展率较低(0.7%vs.4.7%），差异无统计学意义。SCGJT组的出院时间明显缩短（中位数：7vs.8天）。NEWS2评分的变化在组间没有显着差异。SCGJT已被证明可以减少对症状缓解药物的需求，并加快SARS-CoV-2病毒的清除。未报告不良事件，和常规测试没有显着差异。结论SCGJT在非重症COVID-19患者中是安全的，具有潜在的临床疗效。然而,关于预防严重进展的数据仍然没有定论.应根据COVID-19大流行的现状进行进一步的研究。
