Hamdard Laboratories starts proof of concept clinical trial for its two immunity boosting medicines, to prevent infection of COVID-19 in high-risk subjects

New Delhi: Hamdard Laboratories (Medicine Division), a progressive research-based health and wellness organization, announced that it has received all the regulatory approvals to begin the proof of concept clinical trial for its Infuza and Kulzam drugs to prevent COVID-19 infection. A research team from Hamdard Institute of Medical Sciences and Research (HIMSR) is going to start the clinical trial at HAH Centenary Hospital, New Delhi, to evaluate the efficacy of these drugs for the prevention of COVID-19 infection in high-risk subjects.

The research group is working on a randomized, parallel group clinical trial for the repurposing of two popular Hamdard Medicines i.e. Infuza and Kulzum for the prevention of COVID-19 infection at HAHC hospital which conducts more than 100 COVID-19 tests per day. The Department of Microbiology at HIMSR & HAHC Hospital have a Biosafety Levels -2 (BSL-2) laboratory dedicated to RT-PCR testing for COVID-19 by CBNAAT technique. The testing process is certified by National Accreditation Board for Testing and Calibration Laboratories (NABL) an\d Indian Council of Medical Research (ICMR). Free antigen testing is also supported by Delhi Government at HAH Centenary Hospital. The Department is also equipped for COVID-19 serology testing.

Mr. Asad Mueed, Executive Trustee, Hamdard Laboratories India (Medicine Division) said “COVID-19 is arguably the biggest health crisis the world has faced in the 21st century. Hamdard Laboratories India (Medicine division) is working on the best of their capacity to face this pandemic. A research group of Hamdard Institute of Medical Sciences and Research (HIMSR) that comprises an Allopathic doctor, Unani Hakim, Microbiologist and Biochemist is working on a randomized, parallel group clinical trial for the repurposing of two popular Hamdard Medicines i.e. Infuza and Kulzum for the prevention of COVID-19 infection. Infuza has been used in the prevention and treatment of common cold and epidemic flu and popularly used for decades. Unani preparations that have immunomodulatory effects may be very helpful to combat against infectious diseases. Kulzum is one such preparation with chemical constituents like eucalyptol, menthol, thymol, eugenol, and l-limonene and these have anti-inflammatory, anti-microbial and most importantly immunomodulatory activities”

“We have completed the manufacturing of Infuza and Kulzum drugs as per GMP regulations and their quality is validated by using advanced techniques like HPTLC, and GC-MS” said Mr Santosh Joshi, Head, Research & Development, Hamdard Laboratories (Medicine Division).

“Over the next week, we are going to start the clinical trial at HAH Centenary Hospital, New Delhi to evaluate the efficacy of these drugs for the prevention of COVID-19 infection in high risk subjects”, said Dr. G. N. Qazi, Chief Executive Officer, Hamdard Institute of Medical Sciences and Research and associated HAH Centenary Hospital. “The study concept is approved by ‘Special Project Approval Committee’, Ministry of AYUSH and it is also cleared by Institutional Ethics Committee. The trial is registered in Clinical Trial registry of India, Indian Council of Medical Research and the registration number is CTRI/2020/08/027222” added Dr. Qazi.

The clinical trials are an important part of India’s battle in fighting the novel coronavirus. In such unprecedented times, having a strong immune system is the ideal preventive measure while individuals practice social distancing. Hamdard products are developed with natural formulations that combine the benefits of time-tested herbs for strengthening overall immunity, which may be helpful in minimizing the impact of the COVID-19 virus through the development of specific antibodies. Effective adjunct therapy will push up innate immune capability and facilitate the development of specific antibodies to fight against coronavirus infections.