Thiruvananthapuram, 9 July, 2020: Pankajakasthuri Herbals India Private Limited (PKHIL) today announced promising interim clinical trial results for ZingiVir-H among patients suffering from COVID-19. Developed by Dr. J. Hareendran Nair, Founder of Pankajakasthuri Herbal Research Foundation, ZingiVir-H is a herbo-mineral drug made of a blend of seven ingredients. With the announcement, the company hopes to reiterate the tremendous potential of Ayurveda as a cost-effective and scalable solution to critical health conditions such as COVID-19.
Dr. J. Hareendran Nair, Founder and Managing Director, PKHIL, said, “Ayurveda has a long and storied tradition of helping treat a wide range of conditions, from everyday allergies to more complex ones such as autoimmune diseases. During such unprecedented times as now, where our immunity is critical to fighting a disease that has become a global pandemic, we believe that Ayurveda has the power to help develop an effective, cost-efficient and scalable treatment.”
Clinical trials of ZingiVir-H, Pankajakasthuri’s new drug, are underway among 112 patients as an adjunct therapy for the pandemic as well as among 135 additional patients as a stand-alone treatment in a double-blind study. The trials are progressing in 96 of the patients undergoing adjunct therapy. Out of these, the results of 42 patients are being published as an interim report. Among the 42 patients, 22 were treated with ZingiVir-H and 20 were treated with a placebo. It was found that all the 22 patients treated with ZingiVir-H were discharged on the fourth day after real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR). The remaining 20 patients in the control group who received placeboes continued to be COVID-19+ve for 5 to 11 days.
“The results so far have been very positive and the trial is continuing,” said Dr. Nair. “We are equipped to provide the tablet as a treatment for COVID-19 across India and will collaborate with government bodies to ensure effective and quick distribution once the drug is approved. After this, we would also like to extend the treatment to regulators around the world for their respective countries. It is especially important to know that the use of the drug as a prophylactic treatment means that ZingiVir-H can help prevent the spread of COVID-19 and thereby prevent community transmission.”
ZingiVir-H tablets had obtained the Drugs License of the Government of Kerala and underwent cytotoxicity tests on human cells at the Rajiv Gandhi Center for Biotechnology and CSIR-NIIST at Thiruvananthapuram. After the animal studies were proved to be harmless, the clinical trial registration was obtained from the Clinical Trial Registry of India (CTRI). Thereafter, the drug was placed in Randomized Single Blind Placebo Controlled Multi-Center Clinical Trial as per World Health Organization (WHO)'s ICH-GCP standards at various medical colleges with approvals from respective ethical committees.
ZingiVir-H's clinical trial is being conducted similar to the testing protocols in modern medicine. The results will be published after completion of the clinical trials and blood tests, including CRP, ESR, Interleukin, IgG and IgM, have proven the defensive functionality/efficacy of ZingiVir-H.
The interim clinical test results have been evaluated by a 5-member independent peer data monitoring committee (DMC). These included:
· The Chairman of the committee, Dr. V. Raman Kutty, Eminent Epidemiologist and data science expert, Research Director, Amala Cancer Research Centre, Thrissur. He is also a Former Emeritus Professor of Sree Chitra Tirunal Institute for Medical Sciences and Technology and Honorary Chairman, Health Action by People.
· Dr. K. P. Poulose, Former Professor, Kottayam Medical College & George Washington University, USA and Chief Physician, SUT Hospitals, Thiruvananthapuram;
· Dr. K. G. Raveendran, Retd. Medical Director, The Arya Vaidya Pharmacy, Coimbatore;
· Dr. V. S. SUGUNAN, Former Scientist C and Group Leader, Viral Hepatitis Laboratory, Rajiv Gandhi Center for Biotechnology, Thiruvananthapuram; and
· Dr. Asha Kamath, Associate Director, PSPH, Professor & Head, Department of Data Science, Manipal Academy of Higher Education.
Dr. Hareendran Nair also thanked the R&D head of Pankajakasthuri Dr. Shan Sashidharan and the Clinical Trial Coordinator Dr. K. P. Srinivasakumar, Head, Clinical Operations, Institute of Biology and Clinical Research, India, and others associated with it.
After the peer review from the DMC, the test results have been submitted for the approval by the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH).
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