Attenuation of serum inflammatory cytokines in hospitalized COVID-19 patients treated with NRICM101: A preliminary observational study

Background: SARS-CoV-2 infection can induce a hyperinflammatory response through excessive cytokine release, contributing to disease severity and mortality. NRICM101, a government-endorsed multi-herbal traditional Chinese medicine formula, has shown promising immunomodulatory and antiviral effects in preclinical studies. However, clinical evidence on its effect on inflammatory biomarkers in COVID-19 patients remains limited. Methods: To evaluate the clinical effects of NRICM101, we conducted a prospective observational study with non-randomized treatment allocation based on patient consent. A total of 51 hospitalized patients infected with the Alpha variant of SARS-CoV-2 in northern Taiwan (April–June 2021) were included. Fourteen patients received NRICM101 in addition to standard supportive care, while 37 received standard care alone. Serum cytokines—IL-6, IL-16, IP-10, MCP-1, and PDGF-BB—were measured using multiplex immunoassay. Clinical data including disease progression, oxygen requirement, length of hospitalization, and mortality were collected and analyzed. Results: Patients in the NRICM101 group showed significantly lower levels of IL-6 (p = 0.033) and IL-16 (p = 0.040) compared to controls. IP-10 and MCP-1 levels exhibited downward trends without reaching statistical significance. Despite a higher baseline rate of respiratory failure in the NRICM101 group (35.7% vs. 5.4%; P = 0.005), clinical outcomes were comparable between the groups. Conclusions: NRICM101 administration was associated with reduced serum levels of key proinflammatory cytokines, indicating a potential anti-inflammatory effect. Clinical outcomes were comparable between the two groups. NRICM101 may serve as an adjunctive therapy for patients with COVID-19-related hyperinflammation and warrants further evaluation in larger randomized trials.