All India Institute of Ayurveda (AIIA), New Delhi has declared their association with Nisarga Biotech Pvt Ltd, which is a parent company of Nisarga Herbs for conducting a double-blind, placebo controlled, randomized trial at ESIC Medical College and Hospital, Faridabad. Prof. (Dr.) Tanuja Nesari, MD, PhD, Director of AIIA, would be the Principal Investigator along with Dr. Asim Sen, Dean ESIC medical college and hospital, Faridabad would be the co-investigator with team of 6 doctors from AIIA and ESIC.

Nisarga is the 1st Indian Ayurveda company to work along with AIIA, for studying their proprietary neem extract formulation in the prevention of COVID-19 in 250 participants. The study is entitled as ‘Prophylaxis with Neem Capsules (AzadirachtaIndica) in Healthcare Personnel and Relatives in Contact with COVID-19 Patients’ is intended primarily to assess the preventative effect of neem capsules in participants coming in close contact with COVID- 19 patients. The first step of enrolment for this Human trials has started already from 7th August in which the formulation would be tested and studied on 250 participants and it would be a double-blind trial in which 125 participants will be using their proprietary Neem capsules where as the other 125 participants will take blank capsules for 28 days. The drug will be administered for 28 days and followed with an observation period of 28 days and then evaluate the effect of the capsules in comparison with the blank capsules administered.

The meaning of double blind trial is that neither the doctor nor the patient knows what the participant is taking Neem or blank capsules. Thus avoiding any bias evaluation of effect of Neem. Girish Soman, Founder and CEO of Nisarga Biotech Pvt Ltd said that there are few big companies who are carrying out clinical trials through ayurvedic formulations however Nisarga is the 1st manufacturer to perform this trial with its own funds in partnership with India’s apex Ayurveda Hospital and Institute, All India Institute of Ayurveda that is known for research in Ayurveda in a modern technique. Their Neem formulation might prove to be an effective antiviral in preventive use, and they are seeking strategic funding for further research for introducing it as a standard drug.

He further added that Neem is a known antiviral plant, which is used in Ayurveda for several diseases like fever, herpes virus and to purify blood due to its free radical scavenging properties. Ayurveda has huge contribution in prophylaxis of numerous diseases. The rationale for selecting Neem formulation is totally based on prior anti-viral, anti-inflammatory and antioxidant effects of Neem in pre-clinical studies, along with molecular docking studies confirming the binding of neem components to viruses.

Therefore, they are eager to start this study to evaluate its clinical effect for prevention of COVID-19 in front line medical and non-medical staff at ESIC Hospital Faridabad, by a standardised extract made by Nisarga, also being researched by them in association with a US based University of Texas San Antonio at the cancer research center. This trial might result in an affordable treatment option as everyone is talking about learning to live with COVID-19. Neem formulation is the proprietary Ayurvedic formulation from Nisarga’s healthy pipeline comprising of several Ayurvedic drugs that targets neurological ailments, immune disorders, cancer, inflammation, and metabolic diseases, to enter clinical development. Nisarga Herbs has been marketing these products in India and with multiple distribution partners in overseas too.

The All India Institute of Ayurveda (AIIA) is conceived as an Apex Institute for Ayurveda. Its objective is to bring a synergy between Traditional Wisdom of Ayurveda with Modern tools and technology. The institute offers doctoral and postgraduate courses in Ayurveda and focuses on essential research of Ayurveda, drug development with standardization, scientific authentication and safety evaluation of Ayurvedic medicine. The institute also has a 200-bed referral hospital for assisting clinical research. The Institute will soon have 25 Specialty Departments and twelve clinics along with 8 inter-disciplinary research laboratories in which various Scholars can have access for PG & Ph.D. programs every year.

The hospital would be equipped with state of the art modern diagnostic tools and techniques, which will be used in teaching, training and research. The patient care will be conducted primarily by Ayurveda of tertiary level. This institute will have an international collaborative Centre for global promotion as well as research in Ayurveda. ESIC Medical College & Hospital, Faridabad is the leading Medical Institutions under Ministry of Labour & Employment, Govt. of India. It has more than 500 bedded multi-specialty hospital attached to the College. It was started in 2013 and became operational in 2014 with the objectives of offering world class healthcare facilities to the poor workers.

Source: Outlook