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FDA approves first herbal medicine for clinical trial on COVID-19 treatment

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The Food and Drugs Authority (FDA) has approved a herbal medicine known as Cryptolepis sanguinolenta locally known as Nibima for clinical trials for the treatment of COVID-19.

It added that the trials will be conducted at two sites.

This was made known in a communiqué issued on Monday, February 1, 2021, and signed by Chief Executive Officer of FDA, Mrs. Delese A.A. Darko.

According to the Authority, the approval was granted in January 2021.

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

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“The Food and Drugs Authority (FDA), The National Medicine Regulatory Agency (NMRA) in Ghana, has approved a herbal medicine, 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 School of Public Health at the Kwame Nkrumah University of Science and Technology, (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 research team which points in the direction of possible clinical benefits.”

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The Authority added that it gave the authorization after “detailed assessment.”

It insisted that it did so under (Section 150-166) of the Public Health Act 2012 (Act 851).

“The FDA after a detailed assessment of the application gave the requisite regulatory authority for the conduct of the trial as per the mandate outlined under Part 8 (Section 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 at two sites.”

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Below is the full press statement from FDA

6b5861fe 4c59 4cbd b50f cdb3549cf275 - FDA approves first herbal medicine for clinical trial on COVID-19 treatment

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