The Food and Drugs Authority (FDA) expects the clinical trial of the malaria herbal treatment known as Nibima for the treatment of COVID-19 to last two months.
The head of Clinical Trials Department at the FDA, Yvonne Adu Boahene, explained that “the trial duration is for just two months, but medication is taken for seven days of treatment.”
The clinical trials of the repurposed herbal medication will be done at two sites in the Ashanti Region at the Komfo Anokye Teaching Hospital and Kumasi South Hospital.
Mrs. Boahene told Citi News “the FDA is happy about this and is excited, and I think it is a good step for the FDA and Ghana as a whole.”
According to the FDA, after a detailed assessment of the application by researchers from the school of public health at the Kwame Nkrumah University of Science and Technology, it gave the requisite authoriSation for the conduct of the trial.
The researchers in September 2020, submitted the clinical trial application to assess the safety and efficacy of the medicine as a potential treatment for COVID-19 which subsequently received approval in January 2021.
The Centre for Plant Medicine Research (CPMR) had previously recommended 17 herbal medications to the government as a supplementary treatment for the novel coronavirus.
Nine of the 17 recommended herbal remedies were registered products whilst eight others have not yet been approved by the Food and Drugs Authority (FDA).
One of them, Immuno-19, however, contained Cryptolepis Sanguinolenta, which are the Nibima ingredients.
Those recommendations were based on the biological activities of the medicinal plants used in the formulation of the remedies, the status of the product as being FDA registered, the traditional uses of the plant constituents and some chronic toxicity studies and anecdotal clinical data available on the product.