All India Institute of Ayurveda, New Delhi has announced their collaboration with Nisarga Biotech Pvt Ltd, parent company of Nisarga Herbs to conduct a double-blind, randomised, placebo controlled trial at ESIC Medical College and Hospital, Faridabad. Prof. (Dr.) Tanuja Nesari, MD, PhD, Director of AIIA, will be the Principal Investigator and Dr. Asim Sen, Dean ESIC medical college and hospital, Faridabad will be the co-investigator along with team of 6 doctors from AIIA and ESIC. Nisarga is the first Indian Ayurveda company to work with AIIA, who will study their proprietary neem extract formulation for the prevention of Covid-19 in 250 subjects. The study entitled ‘Prophylaxis with Neem Capsules (Azadirachta Indica) in Healthcare Personnel and Relatives in Contact with COVID-19 Patients’ is designed primarily to evaluate the preventative effect of neem capsules in subjects coming in contact with COVID- 19 patients.
The first step of recruitment for this Human trials has already started from 7th August wherein the formulation will be tested and studied on 250 individuals and this would be a double-blind trial where 125 patients would be using their 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. Meaning of double blind is neither the doctor nor the patient knows if he is taking Neem or blank capsules. So any bias in evaluation of effect of Neem is eliminated.
Speaking about it, Girish Soman, Founder and CEO of Nisarga Biotech Pvt Ltd said, “There may be some big companies carrying out clinical trials through ayurvedic formulations but 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.”
“We are excited to launch this study led by Dr. Prof. Tanuja Nesari, MD, PhD, Director, Head and Professor at AIIA, New Delhi. Dr. Nesari has extensive experience in Ayurvedic and modern research and her experience will help in evaluation of proprietary Neem formulation for prevention of Covid-19.” Mr. Girish Soman further added.
Dr. Mohini Barde MD and Medical Director for the trial shared, “Neem is a known antiviral plant used in Ayurveda for various diseases like fever, herpes virus and is known to purify blood due to its free radical scavenging properties. Ayurveda has immense contribution in prophylaxis of various diseases. 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 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 ESIC Hospital Faridabad, with a standardised extract made by Nisarga which is also being researched by them in collaboration with a US based University of Texas San Antonio at the cancer research center. This trial may lead to an affordable treatment option now that we are talking of learning to live with Covid 19.”
Neem formulation is the proprietary Ayurvedic formulation from Nisarga’s robust pipeline that comprises of various Ayurvedic drugs targeting neurological ailments, cancer, immune disorders, inflammation, and metabolic diseases, to enter clinical development. Nisarga Herbs is marketing such products in India and with multiple distribution partners overseas as well.