Preliminary evaluation of the efficacy and safety of a traditional poly-herbal preparation “Desadun Kalka” in reducing symptoms and inflammatory mediators in patients with acute COVID-19

Introduction : During the COVID-19 pandemic, many traditional herbal medicines were used to treat patients with COVID-19. We sought to determine the efficacy and safety of a traditional polyherbal preparation-Desadun Kalka (DK) in reducing symptoms and inflammatory mediators in patients with COVID-19 in Sri Lanka. Methods : We conducted a phase 2, randomized, open labelled clinical trial, in hospitalized adult patients with a confirmed SARS- COV-2 infection, enrolled within the ≤ 4 days since onset of symptoms. Those in the treatment arm (n=76) were given 1250mg of DK three times a day orally, starting from the day of recruitment, up to 4 to 5 days (median 4 days, IQR 4 to 5 days) along with the standard treatment, while those in the control arm (n=76) were given standard treatment. Results: Patients in the DK arm and control arm had similar baseline characteristics except for those in the DK arm having significantly lower (p=0.007) Ct values for SARS-CoV-2 specific RT-qPCR than those in the control arm. DK was well tolerated, and no adverse events were reported. Patients in the DK arm were significantly less likely to have symptoms of a cold (p=0.006) and cough (p=0.006) on day 8 since onset of illness compared to the control group and had a significantly shorter duration of a cough (p=0.006). The CRP levels (p=0.001) and the serum IL-6 levels (p<0.0001) were significantly lower on day 8 of the illness in those who were in the DK arm compared to those in the control arm, while there were no differences in other clinical features, or haematological or biochemical parameters in the DK vs control group. Conclusion : DK appears to have some effect in reducing symptoms and inflammatory mediators in patients with COVID-19 and it would be important to further evaluate the efficacy and mechanisms of action. Trial registration: the trial was registered at the Sri Lanka Clinical trial registry on the 1st of March 2021, International Clinical Trial Registration Platform (SLCTR/2021/005: https://slctr.lk/trials/slctr-2021-005 )