Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial
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 eff...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-01-01
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| Series: | Current Therapeutic Research |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0011393X23000097 |
| _version_ | 1797799157968142336 |
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| author | Mohammad Reza Taghavi, MD Taraneh Tavanaei Tamanaei, MD Mohammad Bagher Oghazian, PharmD, BCPS Erfan Tavana, MD Samaneh Mollazadeh, PhD Parastoo Niloofar, MSc Sahar Oghazian, MD Amin Hoseinzadeh, BSc Amirmohammad Hesari, BSc Mohammad Ansari Mohseni, PharmD Sina Rezaei, PharmD Mahdi Haresabadi, MSc, PhD |
| author_facet | Mohammad Reza Taghavi, MD Taraneh Tavanaei Tamanaei, MD Mohammad Bagher Oghazian, PharmD, BCPS Erfan Tavana, MD Samaneh Mollazadeh, PhD Parastoo Niloofar, MSc Sahar Oghazian, MD Amin Hoseinzadeh, BSc Amirmohammad Hesari, BSc Mohammad Ansari Mohseni, PharmD Sina Rezaei, PharmD Mahdi Haresabadi, MSc, PhD |
| author_sort | Mohammad Reza Taghavi, MD |
| collection | DOAJ |
| description | 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 (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. |
| first_indexed | 2024-03-13T04:14:49Z |
| format | Article |
| id | doaj.art-a18e79a39d104e909db95282a92feec8 |
| institution | Directory Open Access Journal |
| issn | 0011-393X |
| language | English |
| last_indexed | 2024-03-13T04:14:49Z |
| publishDate | 2023-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Current Therapeutic Research |
| spelling | doaj.art-a18e79a39d104e909db95282a92feec82023-06-21T06:50:45ZengElsevierCurrent Therapeutic Research0011-393X2023-01-0198100699Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical TrialMohammad Reza Taghavi, MD0Taraneh Tavanaei Tamanaei, MD1Mohammad Bagher Oghazian, PharmD, BCPS2Erfan Tavana, MD3Samaneh Mollazadeh, PhD4Parastoo Niloofar, MSc5Sahar Oghazian, MD6Amin Hoseinzadeh, BSc7Amirmohammad Hesari, BSc8Mohammad Ansari Mohseni, PharmD9Sina Rezaei, PharmD10Mahdi Haresabadi, MSc, PhD11Clinical Research Development Unit, Imam Hassan Hospital, North Khorasan University of Medical Sciences, Bojnurd, Iran; Department of Infectious Diseases, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, IranDepartment of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, IranClinical Research Development Unit, Imam Hassan Hospital, North Khorasan University of Medical Sciences, Bojnurd, Iran; Department of Internal Medicine, Faculty of Medicine, North Khorasan University of Medical Sciences, Bojnurd, Iran; Address correspondence to: Mohammad Bagher Oghazian, PharmD, BCPS, Clinical Research Development Unit, Imam Hassan Hospital, Kilometer 4 of Arkan Road, Bojnurd 94531-55174, Iran.Student Research Committee, North Khorasan University of Medical Sciences, Bojnurd, IranNatural Products and Medicinal Plants Research Center, North Khorasan University of Medical Sciences, Bojnurd, IranClinical Research Development Unit, Imam Hassan Hospital, North Khorasan University of Medical Sciences, Bojnurd, IranClinical Research Development Unit, Imam Hassan Hospital, North Khorasan University of Medical Sciences, Bojnurd, IranStudent Research Committee, North Khorasan University of Medical Sciences, Bojnurd, IranStudent Research Committee, North Khorasan University of Medical Sciences, Bojnurd, IranResearch and Development Center, Samisaz Pharmaceutical Company, Toos Industrial Zone, Mashhad, IranResearch and Development Center, Samisaz Pharmaceutical Company, Toos Industrial Zone, Mashhad, IranDepartment of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, IranABSTRACT: 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.http://www.sciencedirect.com/science/article/pii/S0011393X230000972725 |
| spellingShingle | Mohammad Reza Taghavi, MD Taraneh Tavanaei Tamanaei, MD Mohammad Bagher Oghazian, PharmD, BCPS Erfan Tavana, MD Samaneh Mollazadeh, PhD Parastoo Niloofar, MSc Sahar Oghazian, MD Amin Hoseinzadeh, BSc Amirmohammad Hesari, BSc Mohammad Ansari Mohseni, PharmD Sina Rezaei, PharmD Mahdi Haresabadi, MSc, PhD Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial Current Therapeutic Research 2725 |
| title | Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial |
| title_full | Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial |
| title_fullStr | Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial |
| title_full_unstemmed | Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial |
| title_short | Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial |
| title_sort | effectiveness of fortified garlic extract oral capsules as adjuvant therapy in hospitalized patients with coronavirus disease 2019 a triple blind randomized controlled clinical trial |
| topic | 2725 |
| url | http://www.sciencedirect.com/science/article/pii/S0011393X23000097 |
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