Department of Biochemistry, Hamdard Institute of Medical Sciences and Research and associated HAHC Hospital, New Delhi, India.
Department of Microbiology, Hamdard Institute of Medical Sciences and Research and associated HAHC Hospital, New Delhi, India.
Phytother Res. 2022 Sep;36(9):3632-3643. doi: 10.1002/ptr.7531. Epub 2022 Jul 5.
COVID-19 is arguably the biggest health crisis the world has faced in the 21st century. Therefore, two of the polyherbal formulations, Infuza and Kulzam were assessed for the prevention of COVID-19 infection as a repurposed medication. Four hundred seven high-risk subjects were recruited in the present open-label randomized controlled clinical trial for eligibility. After assessment for eligibility, remaining 251 subjects were randomized to the test and control groups. Further, 52 high-risk subjects in Infuza, 51 in Kulzam, 51 in Infuza & Kulzam and 53 in control group completed the 14 days of intervention/assessment. The phenotyping of lymphocytes at baseline (0 day) and after 14 days of treatment was carried out by flow cytometry assays. A total of 15.09% high-risk subjects in control group turned positive as compared to only 7.69% in Infuza, 3.92% in Kulzam and 1.96% in Infuza & Kulzam groups. The rate of conversion to COVID-19 infection in Infuza & Kulzam group was minimal and statistically significant as compared to control group (p0.017). No significant changes in phenotype of lymphocytes (T, B, NK cells), absolute lymphocyte count and cytokine levels were found in study groups. However, there was a decreasing trend of hs-CRP level in high-risk subjects after intervention of polyherbal formulations for 14 days. The combination of Infuza and Kulzam may synergistically prevent COVID-19 infection in high-risk subjects of COVID-19.
COVID-19 是 21 世纪全球面临的最大健康危机之一。因此，我们评估了两种复方草药制剂——Infuza 和 Kulzam，将其作为一种重新定位的药物用于预防 COVID-19 感染。本开放性标签随机对照临床试验共招募了 407 名高风险受试者，以评估其入组资格。经过资格评估，剩余的 251 名受试者被随机分配到试验组和对照组。此外，52 名高风险受试者接受 Infuza 治疗，51 名高风险受试者接受 Kulzam 治疗，51 名高风险受试者接受 Infuza 和 Kulzam 联合治疗，53 名高风险受试者接受对照组治疗，共完成了 14 天的干预/评估。通过流式细胞术检测，在基线（0 天）和治疗 14 天后对淋巴细胞进行表型分析。对照组中有 15.09%的高风险受试者检测结果呈阳性，而 Infuza 组、Kulzam 组和 Infuza+Kulzam 组中分别只有 7.69%、3.92%和 1.96%的高风险受试者检测结果呈阳性。与对照组相比，Infuza+Kulzam 组的 COVID-19 感染转化率最低，且具有统计学意义（p<0.017）。在研究组中，未发现淋巴细胞表型（T、B、NK 细胞）、绝对淋巴细胞计数和细胞因子水平有显著变化。然而，在高风险受试者接受 14 天复方草药制剂干预后，hs-CRP 水平呈下降趋势。Infuza 和 Kulzam 的联合使用可能协同预防 COVID-19 高风险人群的 COVID-19 感染。
