FDA approves KNUST’s study into COVID-19 possible treatment
The Food and Drugs Authority (FDA) in collaboration with the National Medicine Regulatory Agency (NMRA) has approved a Clinical Trial Application from the Kwame Nkrumah University of Science and Technology (KNUST) to assess the safety and efficacy of a potential treatment for COVID-19.
The herbal medicine, Cryptolepis sanguinolenta, locally known as Nibima, was studied by researchers from the School of Public Health at the Kwame Nkrumah University of Science and Technology (KNUST), and results point in the direction of “possible Clinical benefits”.
Researchers from the School of Public Health at KNUST submitted a clinical trial application to the FDA to assess the herbal medicine as a possible treatment for COVID-19, and the FDA after a detailed assessment of the application gave a ‘requisite’ regulatory authorization for the conduct of the trial.
The approval was according to the mandate outlined under Part 8 (Sections 150 – 166) of the Public Health Act 2012 (Act 851), which gives the Authority the legal mandate to regulate clinical trials of drugs, herbal medicinal products, cosmetics, or medical devices.
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The trial, however, will be conducted at two sites, according to the FDA.
The KNUST research team has over the years been involved in the FDA’s stakeholder engagements and capacity building activities and has in-depth experience in the international and national regulatory requirements necessary for the effective conduct of clinical trials.
However, the study data is yet to prove its usefulness in relation to COVID-19.
This information was released by the FDA on February 1, 2021, to the general public.
