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

BackgroundCoronavirus 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 patien...

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Published in:	Curēus (Palo Alto, CA) Vol. 15; no. 7; p. e42484
Main Authors:	Giang, Tran Van, Hoa, Le Nguyen Minh, Hien, Tran Thi, Cuong, Quach Duy, Cap, Nguyen Trung, Lam Vuong, Nguyen, Thach, Pham Ngoc
Format:	Journal Article
Language:	English
Published:	Palo Alto Cureus Inc 26-07-2023 Cureus
Subjects:	COVID-19 vaccines Disease transmission Double-blind studies Drug dosages Epidemiology/Public Health Garlic Good Manufacturing Practice Herbal medicine Hospitals Infections Infectious Disease Ingredients Integrative/Complementary Medicine Medicine Pharmacy Respiratory diseases Severe acute respiratory syndrome coronavirus 2 Tropical diseases Viral infections Vietnam
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Summary:	BackgroundCoronavirus 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.MethodsThis 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).ResultsSixty 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.ConclusionsTD0068 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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2168-8184 2168-8184
DOI:	10.7759/cureus.42484