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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 - 20/04/22

Doi : 10.1016/j.biopha.2022.112729 
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 
b Department of Pharmacognosy and Pharmaceutical Biotechnology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran 
c 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 

Corresponding authors.

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Abstract

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, anti-inflammatory, 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 intervention group was significantly accelerated. The mean treatment duration of patients in the intervention group was 4.9 days less than the control group. In addition, no patients in the intervention group were hospitalized compared to 28% of the control group needed to be hospitalized.

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Graphical Abstract




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Highlights

Saliravira® is a natural medicine; composed of Echinacea purpurea, Glycyrrhiza glabra, Rheum palmatum, Hyssopus officinalis, Rosmarinus officinalis, and Panax ginseng.
Saliravira® has the potential to act as an antiviral, anti-inflammatory, and immune-enhancing agent for treatment of COVID-19.
Toxicity studies on mice did not show significant difference between control and intervention groups.
Clinical trial results indicated, viral loads of the patients in the intervention group on the 8th day after the start of treatment was significantly lower in comparison to the control group.

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Keywords : COVID-19, Saliravira, Antiviral agent, Immune-enhancing, Outpatient, Herbal medicine


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