The coronavirus disease-2019 (COVID-19) pandemic crisis has affected millions of people worldwide. The emergence of mutant strains one after the other, breakthrough infections post-vaccination and reinfection of the virus have made it difficult to fight the pandemic and bring an end to it. Naturally available compounds with an array of phytochemicals and potent antiviral properties can provide an alternate solution in improving innate immunity, early recovery and symptomatic cure from COVID-19. The present study investigates the efficacy of a polyherbal formulation, NAOQ19, on the rate of recovery and clinical improvement among COVID-19-infected patients who were not on a ventilator or in intensive care unit. A randomized placebo-controlled study design was adopted for the study. The study enrolled 124 patients with 62 patients included in the NAOQ19 arm and other 62 patients enrolled in the placebo arm along with standard care of treatment. Key outcomes of the study included improvement from COVID-19 based on RT-PCR negative test tested on day 3, 5, 7 and 10, CRP inflammatory rate and drug safety. Data analysis included intention to treat approach. Significance was accepted with a two-sided p value < 0.05 for the outcome measures. The results of the present study demonstrated higher proportion of patients recovering in NAOQ19 arm compared to placebo arm on day 3 (33.8% vs. 8%; p < 0.001). The mean number of days required to turn RT-PCR (Real-time reverse transcriptase-polymerase chain reaction) negative was also lower in NAOQ19 arm by a day compared to placebo arm (5.4 vs. 6.2; p = 0.022). Inflammatory marker CRP (C-reactive protein) significantly reduced in the NAOQ19 arm at exit compared to placebo arm (6.25 mg/L vs. 10.26 mg/L; p = 0.048). Liver function test and kidney function test profiles were within normal limits during exit demonstrating the drug safety. NAOQ19 along with standard care of treatment demonstrated higher percentage of population recovering from COVID-19 in comparison with those who were on standard care of treatment. Trial registration: The trial was also registered in Clinical Trial Registry India with registration number CTRI/2021/10/037423.

中文翻译：

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多草药配方与标准护理对 COVID-19 患者早期康复的疗效：一项随机安慰剂对照试验

2019 年冠状病毒病 (COVID-19) 大流行危机影响了全世界数百万人。突变毒株的相继出现、疫苗接种后的突破性感染和病毒的再感染，使得抗疫和结束疫情变得举步维艰。具有一系列植物化学物质和有效抗病毒特性的天然化合物可以为改善先天免疫力、早期恢复和对症治愈 COVID-19 提供替代解决方案。本研究调查了多草药制剂 NAOQ19 对未使用呼吸机或重症监护病房的 COVID-19 感染患者的康复率和临床改善的功效。该研究采用了随机安慰剂对照研究设计。该研究纳入了 124 名患者，其中 62 名患者纳入 NAOQ19 组，其他 62 名患者纳入安慰剂组并接受标准治疗。该研究的主要结果包括基于第 3、5、7 和 10 天检测的 RT-PCR 阴性结果的 COVID-19 的改善、CRP 炎症率和药物安全性。数据分析包括意向治疗方法。结果测量的双侧 p 值 < 0.05 的显着性被接受。本研究的结果表明，与安慰剂组相比，NAOQ19 组在第 3 天康复的患者比例更高（33.8% vs. 8%；p < 0.001）。与安慰剂组相比，NAOQ19 组的 RT-PCR（实时逆转录酶聚合酶链式反应）转阴性所需的平均天数也缩短了一天（5.4 比 6.2；p = 0.022）。与安慰剂组相比，退出时 NAOQ19 组的炎症标志物 CRP（C 反应蛋白）显着降低（6.25 mg/L vs. 10.26 mg/L；p = 0.048）。退出期间肝功能测试和肾功能测试曲线均在正常范围内，证明了药物安全性。NAOQ19 与标准护理治疗相结合表明，与接受标准护理治疗的人群相比，从 COVID-19 中康复的人群比例更高。试验注册：该试验还在印度临床试验注册中心注册，注册号为 CTRI/2021/10/037423。