Thiruvananthauram-based Pankajakasthuri Herbals India has claimed promising interim clinical trial results for ZingiVir-H, a herbo-mineral drug made of a blend of seven ingredients, among patients suffering from Covid-19.

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, says Dr J Hareendran Nair, Founder of Pankajakasthuri Herbal Research Foundation, who developed ZingiVir-H.

“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,” he added.

Cytotoxicity tests on human cells

ZingiVir-H tablets had obtained the Drugs Licence 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 proved harmless, the clinical trial registration was obtained from the Clinical Trial Registry of India. Thereafter, the drug was placed in Randomised Single Blind Placebo Controlled Multi-Center Clinical Trial as per World Health Organisation’s ICH-GCP standards at various medical colleges with approvals from respective ethical committees.

Clinical trials are underway among 112 patients as an adjunct therapy for the pandemic, as well as among 135 additional patients as a standalone 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 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 positive for five to 11 days.

Positive results, trial on

“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’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 five-member independent peer data monitoring committee (DMC). These included: 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.

Data-monitoring committee

Other were Dr KP Poulose, Former Professor, Kottayam Medical College, and George Washington University, US, and Chief Physician, SUT Hospitals, Thiruvananthapuram; Dr KG Raveendran, Retired Medical Director, The Arya Vaidya Pharmacy, Coimbatore; Dr VS Sugunan, former Scientist C and Group Leader, Viral Hepatitis Laboratory, Rajiv Gandhi Center for Biotechnology, Thiruvananthapuram; and Dr Asha Kamath, Associate Director, Professor and Head, Department of Data Science, Manipal Academy of Higher Education.

Dr Hareendran Nair thanked the R&D head of Pankajakasthuri, Dr Shan Sashidharan, and the Clinical Trial Coordinator, Dr KP Srinivasakumar, Head, Clinical Operations, Institute of Biology and Clinical Research, and others associated with it. After the peer reviews 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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