ESIC Medical College and Hospital, Faridabad and Nisarga Biotech Pvt. Ltd today announced the final data from a pilot, double-blind, randomized, placebo-controlled trial studying prophylactic activity of a proprietary, patent-pending, Neem-leaf extract (Azadirachta Indica A. Juss) of Nisarga Biotech in healthcare personnel and relatives in daily contact with COVID-19 patients. The study was a planned collaboration of ESIC Medical College and Hospital, Faridabad & All India Institute of Ayurveda (AIIA), New Delhi, and was sponsored by Nisarga Biotech Pvt. Ltd, Satara, MS.
The study was conducted in 190 participants of aged 18-60 years at ESIC Medical College and Hospital, Faridabad, between August to December 2020 under the Principal Investigator Prof. (Dr.) Tanuja Nesari, MD, PhD, Director, AIIA & Co Investigator Dr. A. K Pandey ESIC Medical College & Hospital, Faridabad. The study was approved by the Institutional Ethics Committee and registered at Clinical Trial Registry of India (CTRI) and was conducted in accordance with Good Clinical Practice guidelines and according to all applicable local regulatory and ethical requirements.
Results demonstrated the probability of COVID-19 infection in participants receiving Neem capsules 50 mg twice a day for 28-days was reduced to less than half (a relative risk of 0.45) that of participants receiving the placebo, with the effectiveness of Neem capsules being around 55%. Biomarkers and Quality of life (QOL) remained stable in both groups.
Explaining the significance of the results, Dr. Anil Kumar Pandey, MD, Registrar, ESIC Medical College and Hospital, Faridabad, said, “Ayurveda has immense contribution in prophylaxis of various diseases. These study findings are a leap forward for prophylaxis against the COVID 19 specially when there is no specific treatment available for treatment of Covid-19 infection. I am sure it will work great as a preventive as well as additional protection even during the two doses of vaccination where chances of infection are there. Safety is another critical component for prophylactic measures, and we are encouraged to see that the Neem formulation studied in this study has a better and acceptable safety profile.”
“Despite a number of SARS-CoV-2 vaccines gaining marketing authorization, COVID-19 continues to spread, and the majority of Indian population still need effective prophylactic treatment. We are extremely pleased with the outcome of this trial which provides early indications of the potential role of a proprietary, neem-leaf extract from Nisarga Biotech for the prophylaxis of COVID-19,” said Dr. Asim Das, Dean, ESIC Medical College and Hospital.
Girish Soman, Founder and CEO of Nisarga Biotech Pvt. Ltd said, “Nisarga is the first manufacturer to conduct a double-blind placebo-controlled trial for prevention of Covid 19 with comparable efficacy to Vaccines. This is one of the first studies published in peer reviewed international journal in collaboration with two of India’s renowned Ayurveda and medical institutes – AIIA and ESIC Medical College and Hospital, Faridabad. Our Neem formulation has proven to be an effective antiviral in preventive use against COVID-19 with a preventive efficacy rate of 55%. With the second wave hitting the country, our neem formulation is a great alternative for prevention of COVID-19 till the vaccines are widely and easily available in the country.”
The study results have been published in PubMed indexed, peer reviewed journal “Alternative Therapies in Health and Medicine” one of the oldest professional medical journals that covers holistic, natural and alternative medical treatments, in USA and is available online at https://pubmed.ncbi.nlm.nih.gov/33891569/ More information on this clinical study can be found at Clinical Trial Registry of India (CTRI).http://ctri.nic.in. (CTRI/2020/07/026560)