Effectiveness of Gallecina® oral capsules, a fortified garlic extract, as adjuvant therapy in hospitalized patients with coronavirus disease 2019 (COVID-19): A triple-blind randomized controlled clinical trial

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 co-administered 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, a fortified garlic extract, as adjunctive therapy to improve the clinical status and symptoms in non-critically ill patients hospitalized for COVID-19. Methods This triple-blind randomized, placebo-controlled clinical trial was conducted on non-critically ill patients with COVID-19 hospitalized in the non-intensive care wards of Imam Hasan Hospital. Patients received remdesivir plus 90 mg Gallecina® capsule or a placebo every 8 h for five 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 (p=0.04), it was within the normal range for both groups. The proportion of patients necessitating supplemental oxygen for at least one 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 (p=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 non-critically ill COVID-19 patients may warrant further investigation. Clinical trial registration IRCT20201111049347N1. https://en.irct.ir/trial/52245 Date of first registration 16/04/2021

Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial.

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 (P = 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 (P = 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.