Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial

The pathogenesis of COVID-19 includes an integrated immune-inflammatory response. Modulation of host immune responses against the SARS-CoV-2 virus might be effective therapeutic management. Various Unani formulations have an immunomodulatory effect. To explore the immunomodulatory effect and safety of Unani polyherbal drug (Tiryaq Wabai) in COVID-19 patients. The current study was a randomized placebo-controlled clinical trial that included 92 mild to moderate COVID-19 patients randomized into two groups. The Unani formulation Tiryaq Wabai (2 gm orally once a day) was used as an intervention for 45 days, while the control group received a placebo. Both groups received standard care treatment. The primary outcome was 50% increment in absolute lymphocyte count (ALC). The secondary outcome was 50% increment in mean lymphocyte percentage, CD4 cells, and CD8 cell count. The mean increase in all the above parameters has also been studied. Relevant statistical tests were used to analyze the effect. A statistically significant improvement in a 50% increase in ALC (p-value, 0.004), lymphocyte percentage (p-value, 0.056), CD4 (p-value, 0.005), and CD8 cell count (p-value, 0.050) was reported. Also, a significant improvement in the mean value of the lymphocyte percentage (p-value 0.0007), ALC (p-value 0.0022), CD4 cell count (p-value 0.0025), and CD8 cell count (p-value 0.0093) was observed after the treatment. One adverse event of mild grade was reported in the placebo group. The analysis of safety parameters (LFT and KFT) was normal for both groups. In mild to moderate COVID-19 patients, Tiryaq Wabai effectively showed immunomodulatory activity by improving ALC count, lymphocyte percentage, CD4, and CD8 cell count. •Unani polyherbal formulation (Tiryaq Wabai) possesses potent immunomodulatory properties. The contents of Tiryaq Wabai have antiviral, anti-inflammatory, antipyretic, antioxidant, immunomodulatory, bronchodilator, neuroprotective, anticancer, and anti-mutagenic properties.•After 45 days of the treatment, the number of patients with increased ALC, lymphocyte percentage, CD4 cell, and CD8 cell count was significantly higher in the intervention group, compared to the placebo.•A significant improvement in the mean value of lymphocyte percentage (p 0.0007), absolute lymphocyte count (p 0.0022), CD4 cells count (p 0.0025), and CD8 cells count (p 0.0093) was observed after the treatment.•No significant adverse events or deranged LFT, KFT test values were repor