28 June 2021 | News
The randomised clinical trial involved 124 patients
Vedicinals, a German-Indian biotech company based in Pune, has recently announced the results of a WHO registered randomised clinical trial using its Indian regulatory authority approved nutraceutical compound called Vedicinals9. The clinical trial involved 124 patients who showed 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, Ethix Pharma commented, “The study demonstrated that 58 per cent of patients in the Vedicinals9 treatment group were discharged from hospital in the first four to seven days of testing positive compared to the 37 per cent standard care treatment group with improvement to 77.05 per cent of normal X-ray findings in 12 days.”
Vedicinals9 consists of nine bioactive molecules including Baicalin, Quercetin, Luteolin, Rutin, Hesperedin Curcumin, Epigallocatechin Gallate, Piperine, Glycyrrhizin. All these nine 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. These nine bioactive molecules also have supporting published studies conducted by other research teams showing their individual efficacy against the SARS-CoV-2 coronavirus.
Vedicinals9 has already gone through safety studies including toxicity and myocardial infarction studies involving Sprague Dawley Rats. 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 $135 for the Indian market for a set of 14 doses. The product is currently undergoing observational clinical studies in Columbia, Brazil, Iran and Pakistan. A larger randomised human clinical trial is being planned for the US in the state of Oregon and also in the 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 US to develop the same product based on OEM and license of formulation agreement.
Prakash Salunke, MD, Vedicinals 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."
Joachim Gerlach, Chairman, Vedicinals 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.”