Traditional Vietnamese Medicine Containing Garlic Extract for Patients With Non-severe COVID-19: A Phase-II, Double-Blind, Randomized Controlled Trial.

Autor:	Giang TV; Department of Viral and Parasitic Diseases, National Hospital for Tropical Diseases, Hanoi, VNM.; Department of Infectious Diseases, Hanoi Medical University, Hanoi, VNM., Hoa LNM; Department of Microbiology and Molecular Biology, National Hospital for Tropical Diseases, Hanoi, VNM., Hien TT; Department of Viral and Parasitic Diseases, National Hospital for Tropical Diseases, Hanoi, VNM., Cuong QD; Department of Viral and Parasitic Diseases, National Hospital for Tropical Diseases, Hanoi, VNM., Cap NT; Emergency Department, National Hospital for Tropical Diseases, Hanoi, VNM., Lam Vuong N; Department of Medical Statistics and Informatics, Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, VNM., Thach PN; Emergency Department, National Hospital for Tropical Diseases, Hanoi, VNM.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2023 Jul 26; Vol. 15 (7), pp. e42484. Date of Electronic Publication: 2023 Jul 26 (Print Publication: 2023).
DOI:	10.7759/cureus.42484
Abstrakt:	Background Coronavirus disease 2019 (COVID-19) is still ongoing with the omicron variant. Low-cost, effective treatments are still needed, particularly in low-to-middle-income countries. This study assessed the safety and efficacy of TD0068, an herbal medicine developed from mainly garlic, for patients with non-severe COVID-19. Methods This is a phase-II, double-blind, randomized controlled trial to compare oral capsule TD0068 and placebo in adults aged 18-65 years with non-severe COVID-19 between September and October 2021. The efficacy outcomes measured included daily cycle threshold (Ct) value from the time of the initial reverse transcription-polymerase chain reaction (RT-PCR) test, time to viral clearance, daily symptom severity score from 15 symptoms of interest, time to symptom resolution, and progression to severe/critical COVID-19. Safety outcomes included adverse events (AEs) and serious adverse events (SAEs). Results Sixty patients were randomized (31 received TD0068, and 29 received a placebo). The two groups were balanced in baseline characteristics: mean age was 39 years, and female was predominant (66%). Daily Ct value (median on days 3, 5, 7, and 9 was 25.7, 30.8, 35.4, and 37.6 in the TD0068 group, and 26.4, 31.2, 36.0, and 37.4 in the placebo group, respectively) and time to viral clearance (median: 10 vs. 11 days in TD0068 and placebo groups) were similar between groups. Daily symptom severity score (median on days 3, 5, 7, and 9 was 2, 2, 1, and 0 in the TD0068 group, and 3, 2, 1, and 1 in the placebo group), and time to symptom resolution (median: seven vs. nine days, respectively) were also comparable between groups. No SAE occurred in the study. Conclusions TD0068 is safe but does not show an effect for non-severe COVID-19 patients. Further research is needed to explore the potential benefits of garlic in other forms or dosages for the treatment of COVID-19. Competing Interests: The authors have declared that no competing interests exist. (Copyright © 2023, Giang et al.)
Databáze:	MEDLINE
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