PMID- 37637574 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230829 IS - 2168-8184 (Print) IS - 2168-8184 (Electronic) IS - 2168-8184 (Linking) VI - 15 IP - 7 DP - 2023 Jul TI - Traditional Vietnamese Medicine Containing Garlic Extract for Patients With Non-severe COVID-19: A Phase-II, Double-Blind, Randomized Controlled Trial. PG - e42484 LID - 10.7759/cureus.42484 [doi] LID - e42484 AB - 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. CI - Copyright (c) 2023, Giang et al. FAU - Giang, Tran Van AU - Giang TV AD - Department of Viral and Parasitic Diseases, National Hospital for Tropical Diseases, Hanoi, VNM. AD - Department of Infectious Diseases, Hanoi Medical University, Hanoi, VNM. FAU - Hoa, Le Nguyen Minh AU - Hoa LNM AD - Department of Microbiology and Molecular Biology, National Hospital for Tropical Diseases, Hanoi, VNM. FAU - Hien, Tran Thi AU - Hien TT AD - Department of Viral and Parasitic Diseases, National Hospital for Tropical Diseases, Hanoi, VNM. FAU - Cuong, Quach Duy AU - Cuong QD AD - Department of Viral and Parasitic Diseases, National Hospital for Tropical Diseases, Hanoi, VNM. FAU - Cap, Nguyen Trung AU - Cap NT AD - Emergency Department, National Hospital for Tropical Diseases, Hanoi, VNM. FAU - Lam Vuong, Nguyen AU - Lam Vuong N AD - 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. FAU - Thach, Pham Ngoc AU - Thach PN AD - Emergency Department, National Hospital for Tropical Diseases, Hanoi, VNM. LA - eng PT - Journal Article DEP - 20230726 PL - United States TA - Cureus JT - Cureus JID - 101596737 PMC - PMC10452047 OTO - NOTNLM OT - allium sativum OT - covid-19 OT - garlic OT - herbal OT - sars-cov-2 OT - traditional medicine COIS- The authors have declared that no competing interests exist. EDAT- 2023/08/28 06:42 MHDA- 2023/08/28 06:43 PMCR- 2023/07/26 CRDT- 2023/08/28 04:51 PHST- 2023/07/25 00:00 [accepted] PHST- 2023/08/28 06:43 [medline] PHST- 2023/08/28 06:42 [pubmed] PHST- 2023/08/28 04:51 [entrez] PHST- 2023/07/26 00:00 [pmc-release] AID - 10.7759/cureus.42484 [doi] PST - epublish SO - Cureus. 2023 Jul 26;15(7):e42484. doi: 10.7759/cureus.42484. eCollection 2023 Jul.