Covid-19 Treatment: FDA Approves First Herbal Medicine For Clinical Trial
Researchers from the School of Public Health at the Kwame Nkrumah University of Science and Technology (KNUST) have been given the approval to commence clinical trials on 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 has explained that the researchers submitted a clinical trial application in September 2020 to assess the safety and efficacy of the herb.
“The FDA, after detailed assessment of the application gave the requisite regulatory authorization 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 two sites,” FDA said in a statement.
It further noted that the approval comes on the back of results from laboratory studies conducted by the KNUST research team which points in the direction of possible clinical benefits.
“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 statement said.
Below is the FDA statement:
