Abhyankar Mahesh, Kadam Dilip, Reddy P Raghavendra, Siddiqui Mohammed Zaki, Ratheesh M, Jagmag Tariq, Tilwani Jayesh
Internal Medicine, Glowderma Lab Private Limited, Mumbai, IND.
Internal Medicine, Care Multispeciality Hospital, Pune, IND.
Cureus. 2023 Mar 7;15(3):e35881. doi: 10.7759/cureus.35881. eCollection 2023 Mar.
Introduction Coronavirus disease 2019 (COVID-19) is a serious concern of the new era. Along with antiviral synthetic medications, there is a need to discover efficacious herbal antiviral medicines with minimum side effects in patients against COVID-19. This study aimed to assess the efficacy and safety of Imusil® among patients with mild COVID-19. Methods A prospective, randomized, multicenter, open-label, interventional study was conducted in patients with mild COVID-19 infection. Patients received either Imusil one tablet four times a day (seven days) along with the standard of care (SoC) or only SoC. The study endpoints were reverse transcription-polymerase chain reaction (RT-PCR) negativity, changes in cycle threshold (CT), clinical improvement, change in blood inflammatory indexes, and safety assessment. Results A total of 100 patients were enrolled, and 98 received at least one dose of treatment. The median age of patients was 36.0 years, and 58 were males. By day 4, 85.4% of patients in the Imusil+SoC group tested negative for RT-PCR compared to 64% of patients exhibiting the same outcome in the SoC group (P=0.0156). After eight days, clinical improvement was observed in all patients from the Imusil+SoC group, while in the SoC group, clinical improvement was observed in 94.0% of patients (P=0.4947). During follow-up visits, the average C-reactive protein (CRP) levels decreased from baseline in both treatment groups. The decrease in the levels of CRP (-7.3 mg/dL versus -5.5 mg/dL), D-dimer (-231.0 ng/mL versus -151.6 ng/mL), and interleukin 6 (IL-6) (-2.3 pg/mL versus -2.0 pg/mL) at eight days was comparatively higher in the Imusil+SoC group versus the SoC group. There were no serious treatment-emergent adverse events in the drug arm. Conclusion Imusil provides effective antiviral activity and safety in mild COVID-19 patients. Imusil ensures faster RT-PCR negativity and clinical improvement and ensures effective reduction of inflammatory markers such as CRP, D-dimer and interleukin 6.
引言 2019 冠状病毒病（COVID-19）是新时代备受关注的问题。除了抗病毒合成药物外，还需要研发对 COVID-19 患者副作用最小的有效草药抗病毒药物。本研究旨在评估伊姆西尔（Imusil®）在轻度 COVID-19 患者中的疗效和安全性。方法 对轻度 COVID-19 感染患者进行了一项前瞻性、随机、多中心、开放标签的干预性研究。患者接受伊姆西尔，每天四次，每次一片（共七天），同时接受标准治疗（SoC），或仅接受标准治疗。研究终点包括逆转录聚合酶链反应（RT-PCR）阴性、循环阈值（CT）变化、临床改善情况、血液炎症指标变化以及安全性评估。结果 共招募了 100 名患者，98 名患者接受了至少一剂治疗。患者的中位年龄为 36.0 岁，男性 58 名。到第 4 天，伊姆西尔 + SoC 组中 85.4% 的患者 RT-PCR 检测呈阴性，而 SoC 组中这一比例为 64%（P = 〉0.0156）。八天后，伊姆西尔 + SoC 组的所有患者均出现临床改善，而 SoC 组中 94.0% 的患者出现临床改善（P = 0.4947）。在随访期间，两个治疗组的平均 C 反应蛋白（CRP）水平均较基线下降。八天时，伊姆西尔 + SoC 组的 CRP（-7.3 mg/dL 对 -5.5 mg/dL）、D-二聚体（-231.0 ng/mL 对 -151.6 ng/mL）和白细胞介素 6（IL-6）（-2.3 pg/mL 对 -2.0 pg/mL）水平下降幅度相对高于 SoC 组。药物组未出现严重的治疗突发不良事件。结论 伊姆西尔在轻度 COVID-19 患者中具有有效的抗病毒活性和安全性。伊姆西尔可确保更快实现 RT-PCR 阴性和临床改善，并有效降低 CRP、D-二聚体和白细胞介素 6 等炎症标志物水平。
