Indian Biotech Company’s Nutraceutical Compound Shows Promising Use An Adjuvant To Treat COVID-19 In Randomized Clinical Trial.
Date : 03-July-2021 | News Article |
Vedicinals Pvt Ltd, a German-Indian biotech company based in Pune, India has recently announced the results of a WHO registered randomized clinical trial using its Indian regulatory authority approved nutraceutical compound called Vedicinals9.
The clinical trial which involved 124 patients with almost half using the nutraceutical product alongside standard approved COVID-19 treatment protocols showed better clinical outcomes including faster viral clearance, accelerated repair of lung damage, prevention of severe COVID-19 disease progression, improvements of various key biomarkers such as IL-6 and CRP, faster resolution of clinical symptoms such as fever, cough, fatigue etc and also organ protection. http://vedicinalsinternational.com/human-clinical-trials/
Yogendra Kumar Choudhary, Chief Research Officer at Vedicinals Pvt Ltd and CEO at Ethix Pharma Pvt Ltd commented, “The study demonstrated that 58% of patients in the Vedicinals-9 treatment group were discharged from hospital in the first 4 to 7 days of testing positive compared to the 37% standard care treatment group with improvement to 77.05% of normal X-ray findings in 12 days. Comparing the two treatments, a clear significant (p<0.05) difference was seen in the resolution of most symptoms, including fever, dry cough, fatigue, myalgia, sore throat, hypoxia, and dyspnea. The significant improvement (p<0.05) in the prognostic, inflammatory, and immunomodulatory biomarkers assessed as the change from baseline (CFB) to day 5, 12, and 45 in CRP, Total Antibody, IL-6 and change from baseline (CFB) to day 12 and 45 in Ferritin, D-dimer, CD4+ T cell, CD8+ T cell, CD19+ B cell, CD16+/CD56+ NK cell were reported in our randomized, open-label, multi centre, exploratory, Phase II b trial in mild to moderate COVID-19 patients. Overall, the early discharge, improved symptomatology and biomarkers indicate a possible positive effect for Vedicinals-9 as an add-on therapy for the management of COVID-19.”
A long-term evaluation of patients treated with Vedicinals9 showed that most had not developed long-term health complications typically associated with Long COVID.
Vedicinals9 consists of 9 bioactive molecules including Baicalin, Quercetin, Luteolin, Rutin, Hesperedin Curcumin, Epigallocatechin Gallate, Piperine, Glycyrrhizin. All these 9 bioactive molecules were selected based on silico studies, meta-analysis of past published studies, various studies on their drug target pathways and also their ability to be able to correct or stop various human host cellular pathways disruptions caused by the SARS-CoV-2 coronavirus. Details of these are found in the Vedicinals9 white paper. http://vedicinalsinternational.com/whitepaper/
These 9 bioactive molecules also have supporting published studies conducted by other research teams showing their individual efficacy against the SARS-CoV-2 coronavirus. http://vedicinalsinternational.com/bioactive-molecules-in-vedicinals-9/
Vedicinals9 has already gone thru extensive safety studies including toxicity and myocardial infarction studies involving Sprague Dawley Rats. The studies not only showed that Vedicinals9 was a safe product but there was actually data showing that VEDICINALS® 9 provided cardio protective benefits including significant protection of heart muscle tissues, blood vessels and the cardiovascular system.
Vedicinals9 has already been used in a variety of hospital settings throughout India with positive results and is now available throughout the country at leading hospitals, clinics, pharmacies and also through Vedicinals own online shop.
The product is being sold at a net price of about US$135 for the Indian market for a set of 14 doses. This is a merely an introductory price for the next few months to help as many locals access the product at an affordable price. The product is priced much higher in overseas markets.
The product is currently undergoing observational clinical studies in Columbia, Brazil, Iran and Pakistan. A larger randomized human clinical trial is being planned for the United States in the state of Oregon and also in UK.
The product is also undergoing regulatory approval as a nutraceutical supplement in Japan, Thailand, Australia, Indonesia and Singapore.
A major deal is currently underway for one of the largest nutraceutical brands in the United States to develop the same product based on OEM and license of formulation agreement.
Prakash Salunke, Managing Director of Vedicinals Pvt Ltd said, “As of Today (21st June 2021) our product Vedicinals-9 is certified as a nutraceutical product in India by the FSSAI. Our FSSAI License no 10020028000199. As a result of the conclusion of our WHO registered randomized human clinical trial with results reported to both CTRI India ((trial number CTRI – CTRI/2020/10/028364) as will a WHO, we are in the midst of upgrading our certification to that as Food For Specific Medical Purpose (FSMP) which will soon be granted by the FSSAI. Our next obvious step is to continue further studies and trials in order to meet the requirements for compliance and certification of VEDICINALS-9 as a Phyto-pharmaceutical product. We are already receiving an overwhelming response for Vedicinals9 due to its efficacy and are now in the midst of making preparations to scale up production along with our partners.”
Joachim Gerlach, Chairman of Vedicinals Pvt Ltd added, “My main motivation to dedicate so much time and effort into the development of an adjuvant COVID THERAPEUTIC product is part of our corporate philosophy of long-lasting and genuine care for people’s wellbeing. Apart from vaccines, it is very important to also provide therapeutic solutions in order to fight this pandemic and the Long Covid conditions. I stand personally guarantee the honest and scientifically sound methods by which our company operates and the amount of scientific scrutinity we had gone through in the last 15 months to ensure that we have product that has efficacy against the COVID-19 disease and that is backed by scientific research and data. ”
Vedicinal9 as an adjuvant to treat COVID-19 will also put India back on the map again as a leading hub for pharmaceutical and nutraceutical development and production.
The product is also considered effective against emerging SARS-C0V-2 variants based on computation docking studies, studies of its individual constituents against the SARS-CoV-2 coronavirus new variants and also based on informal observation trials conducted.
From the clinical studies, it was also found that Vedicinals9 also protects from any harmful effects from the various drugs used in approved standard treatment protocols in India.