The All India Institute of Ayurveda (AIIA) in collaboration with Nisarga Biotech Pvt Ltd, a parent company of Nisarga Herbs, will conduct a double-blind, randomised, placebo controlled clinical trial to check the preventative effect of Neem capsules in people who have come in contact with COVID-19 patients.
The study is titled ‘Prophylaxis with Neem Capsules (Azadirachta Indica) in Healthcare Personnel and Relatives in contact with COVID-19 patients’.
Nisarga is the first Indian Ayurveda company to work with AIIA, which will study their proprietary Neem extract formulation for the prevention of COVID-19 in 250 subjects.
Human trials have already started and the formulation will be tested and studied on 250 individuals. This would be a double-blind trial where 125 patients would be using Nisarga’s proprietary Neem capsules while the other 125 would be taking blank capsules for 28 days. The drug will be administered for 28 days followed by the observation period of 28 days and check the effect of the capsules in comparison with the blank capsules.
Girish Soman, founder and CEO of Nisarga Biotech said, “Nisarga is the first manufacturer to conduct this trial with its own funds in collaboration with India’s apex Ayurveda Hospital and Institute. All India Institute of Ayurveda is known for researching Ayurveda in a modern way. Our Neem formulation will prove to be an effective antiviral in preventive use, and we are looking at strategic funding for further research to introduce it as a standard drug.”
Dr Mohini Barde MD and medical director for the trial shared, “The rationale for selecting Neem formulation is based on prior anti-inflammatory, anti-viral, and antioxidant effects of Neem in pre-clinical studies, as well as molecular docking studies that confirm the binding of Neem components to viruses. We are therefore excited to start this study to assess its clinical effect for prevention of COVID-19 in front line medical and non-medical staff at Employees' State Insurance Corporation (ESIC) Hospital Faridabad, with a standardised extract made by Nisarga which is also being researched by them in collaboration with US-based University of Texas San Antonio at the cancer research centre. This trial may lead to an affordable treatment option now that we are talking of learning to live with COVID-19.”
The trials will be conducted in ESIC Medical College and Hospital, Faridabad led by Prof. Dr. Tanuja Nesari, MD, PhD, director of AIIA and Dr. Asim Sen, and Dean ESIC medical college will lead the team of six doctors from AIIA and ESIC.