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Vedicinals, a German-Indian biotech company based in Pune, has announced the results of a WHO registered randomized clinical trial using its DCGI approved nutraceutical compound called Vedicinals-9.
The clinical trial involved 124 patients. Almost half used the nutraceutical product alongside standard approved Covid-19 treatment. The patients 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.
Yogendra Kumar Choudhary, chief research officer, Vedicinals and CEO at Ethix Pharma said, “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. Overall, the early discharge, improved symptomatology and biomarkers indicates 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 Vedicinals-9 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.
It is already been used in hospital settings throughout India with positive results and is now available throughout the country.
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.
Prakash Salunke, managing director, Vedicinals said, “Vedicinals-9 is certified as a nutraceutical product in India by the FSSAI via license No. 10020028000199. 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 overwhelming response for Vedicinals-9 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, “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 scrutiny 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, he added.
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