Vopec’s ICMR-endorsed human study for Siddha formulation ‘Amrta Kaurna’ shows positive immune system response in COVID-19 patients
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Nandita Vijay, Bengaluru
August 06 , 2020
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Vopec Pharmaceuticals has completed the ICMR-endorsed clinical trials on its Siddha formulation ‘Amrta Kaurna’ syrup and the study has shown positive immune system response in COVID-19 patients. The proprietary formulation of 5 native Indian herbs is viewed to be a potential therapeutic remedy for the SARS CoV-2 virus by enhancing the immune system response.
This, according to the company, is one of India’s first COVID-19 drugs in Siddha medicine. The clinical trial, registered with ICMR, was approved for a 42-patient human study in June at the Bangalore Medical College and Research Institute (BMCRI) on COVID-19 patients. Notable results for the Amrta Karuna treatment group compared to the control showed significant reduction in hospital quarantine: 5.8 versus 8.1 days which is a 28% decrease. The RT-PCR showed negative on day 7 at 71.42% versus 42.85%. There was a significant reduction in CRP inflammatory levels which reduced the LDH tissue damage levels. The TLC which is the immune system strength was within normal range on day 14.
Dr C R Jayanthi, principal investigator and dean, BMCRI, noted that the results of the study clearly indicated Amrta Karuna syrup proved to have a favourable influence on the immune system in quarantined COVID-19 subjects as compared to the control subjects.
With no specific treatments for COVID-19 and preventive vaccines still being explored, the situation demands development of effective antivirals for prophylaxis and treatment. During the COVID-19 outbreak, the Ayush advisory proposed therapeutic guidelines to manage the viral infection. Coincidentally, all the ingredients in the government guidelines have been used in our formulation, stated Ramukrishnan Karnan, director, Vopec Pharmaceuticals.
Based on in-silico models, Dr M G Dinesh, research head, Vopec told Pharmabiz that the phyto-constituents in Amrta Karuna act on ACE2-Spike interaction, inhibiting the entry of the virus into the host cell, and on NSP15 protein to prevent its replication. Pre-clinical in-vitro studies demonstrated the safety and efficacy of Amrta Karuna and confirmed its potential as an immunomodulatory agent against dengue, H1N1 and H5N1 viruses. Confirmatory in-vitro studies in the US are underway on the SARS-CoV-2 virus through Agastiya Biotech in California.
“Our clinical trial proves the antiviral and immunomodulatory therapeutics of Amrta Karuna. Its mechanism is attributed to the 5 anti-viral herbs from the 5,000-year old Indian medicine system. Besides being anti-viral, the five herbs also have strong immunomodulatory therapeutics,” said Dr Baskaran Pillai, chairman, Vopec.
“Herbal formulations have scalability and other issues. So, Vopec currently has a small molecule under research to circumvent these problems. We invite pharmaceuticals, hospitals and researchers to partner with us in our fight against the pandemic,” he added.
Vopec recently licensed Amrta Karuna to US based Nambu Botanicals.
The three decade old Vopec is a licensed Siddha and ayurvedic pharmaceutical manufacturer founded by Kannan, former director, Tamil Nadu drugs control department. Dr. Pillai acquired Vopec in 2013 to create new medicine for the 21st century through combining western biotech and traditional Indian therapeutics.
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