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FDA approves first herbal drug for COVID-19 clinical trial

FDA approves first herbal drug for COVID-19 clinical trial

The Food and Drug Administration (FDA) has approved Cryptolepis sanguinolenta, also known locally as Nibima, for clinical trials for the treatment of COVID-19.

The trials will take place at two different locations, according to the statement.

This was announced in a press release issued on Monday, February 1, 2021, and signed by FDA Chief Executive Officer, Mrs. Delese A.A. Darko.

The Authority stated that the approval was granted in January 2021.

The herbal medicine was submitted by the “School of Public Health at Kwame Nkrumah University of Science and Technology, (KNUST), which submitted a clinical trial application in September 2020,” according to the statement.

“In Ghana, the Food and Drugs Authority (FDA) and the National Medicine Regulatory Agency (NMRA) have approved a herbal medicine.”

Also read: Adhere to COVID-19 safety protocols – Akufo-Addo

The herbal medicine was submitted by the “School of Public Health at Kwame Nkrumah University of Science and Technology, (KNUST), submitted a clinical trial application in September 2020,” according to the statement.

“The Food and Drugs Authority (FDA), Ghana’s National Medicine Regulatory Agency (NMRA), has approved Cryptolepis sanguinolenta, locally known as Nibima, for clinical trials in January 2021.”

“In the search for a treatment for the ongoing COVID-19 pandemic, researchers from the Kwame Nkrumah University of Science and Technology’s (KNUST) School of Public Health submitted a clinical trial application in September 2020 to assess the safety and efficacy of Cryptolepis sanguinolenta as a potential COVID-19 treatment.”

This follows the findings of laboratory studies conducted by the KNUST research team, which point to potential clinical benefits.”

The Authority also stated that the authorization was granted after a “detailed assessment.”

It insisted on doing so in accordance with Section 150-166 of the Public Health Act of 2012. (Act 851).

“After a thorough review of the application, the FDA granted the necessary regulatory authority for the trial’s conduct in accordance with the mandate outlined in Part 8 (Section 150-166) of the Public Health Act 2012 (Act 851), which gives the Authority the legal authority to regulate clinical trials of drugs, herbal medicinal products, cosmetics, or medical devices.” The trial will take place in two locations.”

Below is the full press statement from FDA

 

 


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