The study evaluates the effects of a Neem formulation in a double blind trial, indicating 55% efficacy in prevention of Covid-19.

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In February 2021, ESIC Medical College and Hospital, Faridabad, and Nisarga Biotech Pvt Ltd, revealed the final data from a pilot, double-blind, randomised, placebo-controlled trial studying prophylactic activity of a proprietary, patent-pending, Neem-leaf extract (Azadirachta Indica A. Juss) of Nisarga Biotech in healthcare professionals and relatives of Covid-19 patients.

The study is a collaboration of ESIC Medical College and Hospital & All India Institute of Ayurveda (AIIA), New Delhi, and was sponsored by Nisarga Biotech Pvt Ltd, Satara, Maharashtra.

The study was conducted on 190 participants of age 18-60 years at ESIC Medical College and Hospital, 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. It was approved by the Institutional Ethics Committee (IEC) and registered at Clinical Trials Registry – India (CTRI), and was conducted in accordance with Good Clinical Practice guidelines as per applicable local regulatory and ethical requirements.

The results of the study demonstrated that 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) of that of participants taking the placebo, with the effectiveness of neem capsules being around 55%. Biomarkers and Quality of Life (QOL) remained stable in both groups.

Elaborating on the significance of the results, Dr Anil Kumar Pandey, MD, Registrar, ESIC Medical College and Hospital, says, “Ayurveda has immense contribution in prophylaxis of various diseases. These study findings are a step forward for prophylaxis against Covid-19, especially when there is no specific treatment available for treatment of Covid-19 infection. I am sure it will work well as a preventive measure, as well as, an additional protection even post the two doses of vaccination, which do not rule out chances of infection. Safety is another critical factor for prophylactic measures, and we are encouraged to see that the Neem formulation used in this study has a better and acceptable safety profile.”

“Despite a number of SARS-CoV-2 vaccines gaining marketing authorisation, Covid-19 continues to spread, and the majority of the population still needs 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 for the prophylaxis of Covid-19,” says Dr Asim Das, Dean, ESIC Medical College and Hospital.

Girish Soman, Founder and CEO of Nisarga Biotech Pvt Ltd, says, “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 pioneering studies published in a peer-reviewed international journal in collaboration with two of India’s renowned Ayurveda and medical institutes – AIIA and ESIC Medical College and Hospital. Our Neem formulation has proven to be an efficacious antiviral in preventive use against Covid-19, with a preventive efficacy rate of 55%. With the second wave hitting the country hard, this is a great alternative for prevention of Covid-19 until vaccines are widely and easily available in the country.”