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Efficacy of a multiple-indication antiviral herbal drug (Saliravira®) for COVID-19 outpatients: A pre-clinical and randomized clinical trial study

Khorshiddoust et al., Biomedicine & Pharmacotherapy, doi:10.1016/j.biopha.2022.112729, IRCT20201220049771N1
Feb 2022  
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Hospitalization 98% Improvement Relative Risk Recovery time 35% Viral load, day 4 63% no CI Viral load, day 8 33% no CI Saliravira  Khorshiddoust et al.  EARLY TREATMENT  RCT Is early treatment with Saliravira beneficial for COVID-19? RCT 143 patients in Iran (December 2020 - March 2021) Lower hospitalization (p<0.0001) and faster recovery (p<0.0001) c19early.org Khorshiddoust et al., Biomedicine & Ph.., Feb 2022 FavorsSaliravira Favorscontrol 0 0.5 1 1.5 2+
RCT COVID-19 outpatients showing faster recovery and lower hospitalization with Saliravira, an antiviral drug combining oral tablets, a nasal spray, an oral spray, and inhalation, and containing glycyrrhiza glabra, echinacea purpurea, rheum palmatum, hyssopus officinalis, rosmarinus officinalis, and panax ginseng. Baseline details per group are not provided.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
risk of hospitalization, 97.6% lower, RR 0.02, p < 0.001, treatment 0 of 87 (0.0%), control 16 of 56 (28.6%), NNT 3.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
recovery time, 35.0% lower, relative time 0.65, p < 0.001, treatment mean 8.9 (±5.5) n=87, control mean 13.7 (±3.3) n=56.
viral load, 63.0% lower, relative load 0.37, treatment 87, control 56, day 4.
viral load, 33.0% lower, relative load 0.67, treatment 87, control 56, day 8.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Khorshiddoust et al., 17 Feb 2022, Randomized Controlled Trial, Iran, peer-reviewed, mean age 50.1, 39 authors, study period 21 December, 2020 - 1 March, 2021, trial IRCT20201220049771N1.
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Abstract: Biomedicine & Pharmacotherapy 149 (2022) 112729 Contents lists available at ScienceDirect Biomedicine & Pharmacotherapy journal homepage: www.elsevier.com/locate/biopha Efficacy of a multiple-indication antiviral herbal drug (Saliravira®) for COVID-19 outpatients: A pre-clinical and randomized clinical trial study Reza Ramazani Khorshiddoust a, *, Saleh Ramazani Khorshiddoust a, Tahereh Hosseinabadi b, *, Faezeh Mottaghitalab a, *, Farzad Mokhtari a, Fatemeh Azadinia a, Hossein Mozdarani c, Mohammad Shabani d, Hamid Emadi-Kouchak e, Bahram Taheri f, Fatemeh Khani-Juyabad a, Mina Amjadi Kashani a, Arezoo Sadoughi g, Sorour Zamanizadeh g, Hadyeh Maddah g, Maedeh Aminzadeh g, Maryam Khanaki g, Sabereh Saremi g, Anahita Pashaee Rad g, Ali Fatehi h, Melika Ghaznavi Rad a, Masoud Haftbaradaran i, Mehran Khosroshahi i, Mahtab Sadeghi i, Majid Aminnayeri g, Sirous Jafari e, Fereshteh Ghiasvand e, Arash Seifi e, Sara Ghaderkhani e, Seyed Ali Dehghan Manshadi e, Mohammadreza Salehi e, Ladan Abbasian e, Malihe Hasannezhad e, Mohsen Meidani e, Mahboubeh Hajiabdolbaghi e, Zahra Ahmadinejad e, Masoud Parash e, Zahra Sedighi e, Abdorreza Mohammadian e a R&D Group, MIM Pharma, Oslo, Norway Department of Pharmacognosy and Pharmaceutical Biotechnology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran Department of Medical Genetics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran d Department of Biochemistry, School of Medicine, Iran University of Medical Sciences, Tehran, Iran e Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran f Nexus & HSE Center, Amirkabir University of Technology, Tehran, Iran g Aramesh Multi-Professional Pain Clinic, Tehran, Iran h Department of Industrial Engineering and Management Systems, Amirkabir University of Technology, Tehran, Iran i MIM Daroo, Tehran, Iran b c A R T I C L E I N F O A B S T R A C T Keywords: COVID-19 Saliravira Antiviral agent Immune-enhancing Outpatient Herbal medicine Background: The scientific researches on COVID-19 pandemic topics are headed to an explosion of scientific literature. Despite these global efforts, the efficient treatment of patients is an in-progress challenge. Based on a meta-study of published shreds of evidence about compounds and their botanic sources in the last six decades, a novel multiple-indication herbal compound (Saliravira®) has been developed. Based on the antiviral, antiinflammatory, and immune-enhancing properties of its ingredients, we hypothesized that Saliravira® has the potential to act as an antiviral agent, accelerate treatment, and reduce undesirable effects of COVID-19. Methods: In this randomized, controlled, open-label clinical trial, COVID-19 outpatients were included by RT-PCR test or diagnosis of physicians according to the symptoms. Participants were randomly divided into intervention and control groups to receive Saliravira® package plus routine treatments of COVID-19 or routine treatments of COVID-19 alone, respectively. Saliravira® package includes tablets, nasal-sinuses spray, oral-pharynx spray, and inhaler drops. The treatment was for 10 days and followed up till 23 days after admission. Results: On the 8th day, the “mean reduction rates” of viral load of the patients in the intervention group was 50% lower compared to the control group with a p-value < 0.05. The improvement of 10 out of 14 COVID-19 symptoms in the..
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