Researchers from the School of Public Health at the Kwame Nkrumah University of Science and Technology have received approval to commence clinical trials of a potential treatment for COVID-19.
The approval, which was granted by Ghana’s Food and Drugs Authority (FDA) and the National Medicine Regulatory Agency (NMRA), is for the herb Cryptolepis sanguinolenta, known locally as Nibima, Kadze and Gangamau.
The FDA, in a press release, said the approval follows “results from laboratory studies conducted by the KNUST research team which point in the direction of possible clinical benefits.
“The FDA, the National Medicine Regulatory Agency in Ghana, has approved a herbal medicine, Cryptolepis sanguinolenta, locally known as Nibima for clinical trials in January 2021,” the release said.
“In search for a treatment for the ongoing COVID-19 pandemic researchers from the School of Public Health at KNUST, submitted a clinical trial application in September 2020 to assess the safety and efficacy of Cryptolepis sanguinolenta as a potential treatment for Covid-19. This follows results from laboratory studies conducted by the KNUST’s research team which point in the direction of possible clinical benefits,” it said.
Clinical trials involve the test of potential treatments in human volunteers to see whether they should be approved for wider use in the general population.
The potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials.
The FDA statement said the KNUST application received approval after a detailed assessment and the Nibima trial will be conducted on two sites.
It also assured that the sites have the capacity to ensure the safety of participants as well as produce credible scientific data.
“The FDA, after detailed assessment of the application, gave the requisite regulatory authorisation for the conduct of the trial as per 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. The trial will be conducted at two sites,” the release said.
“The research team has over the years been involved in FDA’s stakeholder engagements and capacity building activities and has an in-depth experience as well as the knowledge in international and national regulatory requirements requisite for the effective conduct of clinical trials,” the release noted.