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Abstract：
Background: The COVID-19 pandemic has had a profound global impact, although the majority of recently infected cases have presented with mild to moderate symptoms. Previous clinical studies have demonstrated that Shufeng Jiedu (SFJD) capsule, a Chinese herbal patent medicine, effectively alleviates symptoms associated with the common cold, H1N1 influenza, and COVID-19. This study aimed to assess the efficacy and safety of SFJD capsules in managing symptoms of mild to moderate COVID-19 infection. Methods: A randomized, double-blind, placebo-controlled trial was conducted from May to December 2022 at two hospitals in China. Mild and moderate COVID-19-infected patients presenting respiratory symptoms within 3 days from onset were randomly assigned to either the SFJD or placebo groups in a 1:1 ratio. Individuals received SFJD capsules or a placebo three times daily for five consecutive days. Participants were followed up for more than 14 days after their RT-PCR nucleoid acid test for SARS-CoV-2 turned negative. The primary outcome measure was time to alleviate COVID-19 symptoms from baseline until the end of follow-up. Results: A total of 478 participants were screened; ultimately, 407 completed the trial after randomization (SFJD, n = 203; placebo, n = 204). No statistically significant difference in baseline parameters was observed between the two groups. The median time to alleviate all symptoms was 7 days in the SFJD group compared to 8 days in the placebo group (p = 0.037). Notably, the SFJD group significantly attenuated fever/chills (p = 0.04) and headache (p = 0.016) compared to the placebo group. Furthermore, the median time taken to reach normal body temperature within 24 h was reduced by 7 hours in the SFJD group compared to the placebo group (p = 0.033). No deaths or instances of serious or critical conditions occurred during this trial period; moreover, no serious adverse events were reported. Conclusion: The trial was conducted in a unique controlled hospital setting, and the 5-day treatment with SFJD capsules resulted in a 1-day reduction in overall symptoms, particularly headache and fever/chills, among COVID-19-infected participants with mild or moderate symptoms. Compared to placebo, SFJD capsules were found to be safe with fewer side effects. SFJD capsules could potentially serve as an effective treatment for alleviating mild to moderate symptoms of COVID-19. Clinical Trial Registration: https://www.isrctn.com/, identifier ISRCTN14236594.
摘要：
背景：COVID-19大流行对全球产生了深远的影响，尽管大多数最近感染的病例都表现为轻度至中度症状。先前的临床研究表明，疏风解毒（SFJD）胶囊，一种中草药，有效缓解与普通感冒相关的症状，甲型H1N1流感,和COVID-19。本研究旨在评估SFJD胶囊治疗轻中度COVID-19感染症状的有效性和安全性。方法：随机，双盲,安慰剂对照试验于2022年5月至12月在中国两家医院进行.在发病后3天内出现呼吸道症状的轻度和中度COVID-19感染患者以1：1的比例随机分配到SFJD或安慰剂组。个体连续五天每天三次接受SFJD胶囊或安慰剂。在SARS-CoV-2的RT-PCR类核苷酸测试变为阴性后，对参与者进行了14天以上的随访。主要结局指标是从基线到随访结束，缓解COVID-19症状的时间。结果：共筛选了478名参与者；最终，407在随机分组后完成了试验(SFJD，n=203；安慰剂，n=204）。两组间基线参数无统计学差异。SFJD组缓解所有症状的中位时间为7天，而安慰剂组为8天（p=0.037）。值得注意的是,与安慰剂组相比,SFJD组明显减轻了发热/寒战(p=0.04)和头痛(p=0.016).此外，与安慰剂组相比,SFJD组24小时内达到正常体温所需的中位时间缩短了7小时(p=0.033).在本试验期间，没有发生死亡或严重或危急状况的情况；此外，未报告严重不良事件.结论：该试验是在独特的受控医院环境中进行的，用SFJD胶囊治疗5天，总体症状减轻1天，特别是头痛和发烧/发冷，在有轻度或中度症状的COVID-19感染参与者中。与安慰剂相比，SFJD胶囊被发现是安全的，副作用较少。SFJD胶囊可能是缓解COVID-19轻中度症状的有效治疗方法。临床试验注册：https://www.isrctn.com/,标识符ISRCTN14236594。
