A randomised, double-blind, placebo-controlled evaluation of polyphenol-based standardised cinnamon bark extract in patients with mild-to-moderate COVID-19

Abstract

Objectives

To evaluate the efficacy and safety of oral supplementation of polyphenol-based standardised cinnamon bark extract (IND02) capsules to ‘standard of care’ (SoC) in mild-to-moderate patients with coronavirus disease (COVID-19) in a randomised double-blind, placebo-controlled study.

Design and methods

A total of 118 participants (aged 18–60 years, both sexes) were randomised to have 15 days of regimen of IND02 or placebo capsules in two stages: a loading dose of 3 g/d for the initial three days and a maintenance dose of 1.5 g/d for the subsequent 12 days. Efficacy and safety outcome measures were based on guidelines issued by ‘Ministry of Health and Family Welfare, Government of India’.

Results

All patients in both treatment groups showed clinical recovery and improvement without significant differences between the groups. The number of patients with negative COVID-19 status and having enhanced (>2% increase) oxygen saturation (SpO₂) was significantly (P = 0.039 and P = 0.049, respectively) higher in the IND02 supplemented group (vs. Placebo), but no significant differences in other outcome measures between the groups. No serious adverse events, deaths, or treatment-related adverse effects were observed. None of the patients in either group required discontinuation of treatment or ventilation support, progressed to a severe stage, or had changes in vital signs or laboratory examination results.

Conclusion

IND02 supplementation with SoC in COVID-19 patients with mild-to-moderate symptoms was safe and well-tolerated, with improved oxygen saturation and an increased number of patients achieving negative status for clinical recovery and improvement.