ABSTRACT
Background: Herbal medicines have been extensively used to treat coronavirus disease 2019 (COVID-19). Garlic, known to exert antiviral and anti-inflammatory effects, can be coadministered with standard treatments to combat COVID-19. Objectives: The aim of the study was to evaluate the efficacy and safety profile of Gallecina oral capsules (Samisaz Pharmaceutical Company, Mashhad, Iran), a fortified garlic extract, as adjunctive therapy to improve the clinical status and symptoms in noncritically ill patients hospitalized for COVID-19. Methods: This triple-blind randomized, placebo-controlled clinical trial was conducted on noncritically ill patients with COVID-19 hospitalized in the nonintensive care wards of Imam Hassan Hospital. Patients received remdesivir plus 90 mg Gallecina capsule or a placebo every 8 hours for 5 days or until discharge. The clinical status, respiratory symptoms, and laboratory parameters were recorded during the study period. Results: Patients were enrolled between April 24 and July 18, 2021. Data from 72 patients in the Gallecina group and 69 patients in the placebo group were analyzed. Oxygen saturation, C-reactive protein levels, and the distribution of respiratory distress and cough were similar between groups on the day of discharge. Although body temperature was significantly lower in the Gallecina group than that in the placebo group on the day of discharge (Pâ¯=â¯0.04), it was within the normal range for both groups. The proportion of patients requiring supplemental oxygen for at least 1 day during the study was significantly reduced in the Gallecina group on days 3 and 4 and the day of discharge (P < 0.05). Gastrointestinal complaints were more prevalent in the Gallecina group than in the placebo group but the difference was not statistically significant (Pâ¯=â¯0.12). Conclusions: There was no significant effect on the primary outcome of clinical status on study day 6. Although the proportion of Gallecina-treated patients who needed supplemental oxygen significantly decreased on days 3 and 4 and the day of discharge, there was no significant difference between the groups on other days. The possible beneficial effects on oxygen requirements in noncritically ill COVID-19 patients may warrant further investigation. (Curr Ther Res Clin Exp. 2023; 84:XXX-XXX). Clinical trial registration: IRCT20201111049347N1.
ABSTRACT
BACKGROUND: Misinformation about the prevalence of COVID-19 vaccines' side effects (SEs) has led to concerns about and mistrust of vaccine safety. Thus, this study aimed to evaluate the prevalence of COVID-19 vaccines' SEs. METHODS: In a cross-sectional survey-based study on the healthcare workers (HCWs) of a tertiary hospital in Iran, the SEs of Sputnik V, Oxford-AstraZeneca, Sinopharm, and Covaxin were evaluated through a face-to-face interview by a researcher-made questionnaire. RESULTS: A total of 368 HCWs received at least one dose of a COVID-19 vaccine. The prevalence of people with at least one SE was higher among those who received the Oxford-AstraZeneca (95.8 %) and Sputnik V (92.1 %) vaccines than those who received Covaxin (70.5 %) or Sinopharm (66.7 %). Following the first and second doses, injection site pain (50.3 % and 58.2 %), body/muscle pain (53.5 % and 39.4 %), fever (54.5 % and 32.9 %), headache (41.3 % and 36.5 %), and fatigue (44.4 % and 32.4 %) were the most common SEs. Overall, SEs were often initiated within 12 h and subsided within 72 h of vaccination. The prevalence of SEs after the first dose of Sputnik V was higher among those aged ≤ 31 years (93.3 %) than those aged > 31 years (80.5 %). In the Sputnik V group, the number of SEs experienced after the first dose was higher in women with underlying diseases than those without such diseases. Furthermore, the body mass index of participants with SEs was lower than that of participants without SEs. CONCLUSION: Compared to Sinopharm or Covaxin, the Sputnik V and Oxford-AstraZeneca vaccines were associated with a higher prevalence of SEs, a greater number of SEs per individual, and more severe SEs.