Advancing combination treatment with glycyrrhizin and boswellic acids for hospitalized patients with moderate COVID-19 infection: a randomized clinical trial
RCT with 50 hospitalized COVID+ patients in Egypt, 25 treated with glycyrrhizin and boswellic acid, showing improved recovery with treatment. Glycyrrhizin 60mg and boswellic acid 200mg bid for 2 weeks. NCT04487964 (history)
risk of death, 90.9% lower, RR 0.09, p = 0.05, treatment 0 of 25 (0.0%), control 5 of 25 (20.0%), NNT 5.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 14.
risk of mechanical ventilation, 90.9% lower, RR 0.09, p = 0.05, treatment 0 of 25 (0.0%), control 5 of 25 (20.0%), NNT 5.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 14.
recovery time, 44.0% lower, relative time 0.56, p < 0.001, treatment 25, control 25.
risk of no recovery, 33.3% lower, RR 0.67, p < 0.001, treatment 25, control 25, relative clinical status, day 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gomaa et al., 1 Mar 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Egypt, peer-reviewed, median age 60.0, 5 authors, study period June 2021 - November 2021, average treatment delay 6.0 days, this trial uses multiple treatments in the treatment arm (combined with boswellic acid) - results of individual treatments may vary, trial NCT04487964 (history)
Abstract: Inflammopharmacology (2022) 30:477–486
Advancing combination treatment with glycyrrhizin and boswellic
acids for hospitalized patients with moderate COVID‑19 infection:
a randomized clinical trial
Adel A. Gomaa1
· Hamdy S. Mohamed4 · Rasha B. Abd‑ellatief1 · Mohamed A. Gomaa2 · Doaa S. Hammam3
Received: 4 February 2022 / Accepted: 8 February 2022 / Published online: 1 March 2022
© The Author(s) 2022
Recent evidence points to a potential therapeutic role for glycyrrhizin(GR) and boswellic acids (BA) in the treatment of
COVID-19 but conclusive evidence is lacking. Our aim is to investigate the efficacy of GR + BA versus placebo for the
treatment of hospitalized patients with moderate SARS-CoV-2 or COVID-19 variants infection. The current study is a randomized, double-blind, placebo-controlled, single-center trial. Patients with SARS-CoV-2 or COVID-19 variants diagnosed by
PCR test who were admitted to Sohag University hospital were eligible if they were at least 18 years of age and had moderate
symptoms. Patients were randomly assigned to receive oral GR capsule (60 mg) and BA (200 mg) twice daily for 14 days
or a matching placebo. All patients also received treatment with the institutional protocol for COVID-19. The primary outcome was mortality and time to recovery. Secondary outcome was clinical status score, 14 days after receiving study drugs.
Adverse events from use of study drugs have been evaluated for up to 14 days. The trial is registered at ClinicalTrials.gov
(Identifier NCT04487964). During the 6-month enrollment period (June-November, 2021) only 50 patients (54% women;
median age 60 years, IQR 54–65) met eligibility and were randomly assigned. Evaluation of the primary outcome at 14 days
showed that there were five deaths in the placebo group and no deaths in the GR + BA group. With regard to recovery time,
it was significantly shorter (p = 0.0001) in the group receiving GR + BA capsule compared to the placebo group (median
7.0; IQR 6.0–8.0 days vs. median 12.5; IQR 12–20 days). Clinical status on the ordinal score scale as a secondary outcome
showed a significant difference between the GR + BA group (median (IQR) score, 2 [2–3]) and placebo groups (mean (IQR)
score, 3 [3–5.5]). There was a significant decrease in CRB (p = 0.000041) in GR + BA compared with the placebo group. In
conclusion, this safe, inexpensive, antiviral, immunomodulating and anti-inflammatory combination may be considered for
use in mild to moderate infections of SARS-CoV-2 or COVID-19 variants. The study is limited by the small sample size;
therefore, larger randomized trials are required.
Keywords COVID-19 · Glycyrrhizin · Boswellic aids · Mortality rate · Time to recovery · Clinical status score
BA Boswellic acids
ACE2 Angiotensin-converting enzyme 2
* Adel A. Gomaa
Department of Medical Pharmacology, Faculty of Medicine,
Assiut University, Assiut, Egypt
Department of Plastic Surgery, Faculty of Medicine, Assiut
University, Assiut, Egypt
Department of Pharmacology & Toxicology, Faculty
of Pharmacy, Assiut University, Assiut, Egypt
Department of Internal Medicine, Faculty of Medicine,
Sohag University, Sohag, Egypt
COVID-19 Coronavirus disease 2019
CRB C-reactive protein
HMGB1 High-mobility group box 1 protein
HsGAPDH Human GAPDH
IQR Interquartile rang
NLRP3 Nod-like receptor..
is less effective
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