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KNUST researchers caution against use of herbal medicine approved by FDA for clinical trials

The COVID-19 clinical trial team at the Kwame Nkrumah University of Science and Technology (KNUST) have warned the public against using Cryptolepis songuinolenta (CS) as a treatment drug for persons infected with the virus.

The scientists say they have taken notice of the excitement of Ghanaians over the announcement made by the Food and Drugs Authority (FDA) that it has approved the CS herbal medicine for phase II clinical trials on COVID-19 patients.

In a statement, the team clarified what it describes as a misinterpretation of the approval as use of CS in Coronavius therapy by the FDA.

“The KNC19 team wishes to inform the public that, the herbal remedy in question has not been approved presently for COVID-19 management but rather for a phase II clinical trial on COVID-19 patients.”

It added that “although preliminary results from our laboratory strongly point in the direction of potential clinical benefits, our team wants to caution the public against the mass use of Cryptolepis sanguinolenta for COVID-19 treatment until there is enough scientific evidence from our clinical study and subsequent market authorization from the FDA.”

The team also reminded the public that, the study is expected to last for three months and that it will provide updates accordingly.

The KNUST COVID-19 clinical trial team called the KNC19 consists of clinicians and scientists across faculties at KNUST, Komfo Anokye Teaching -Hospital (KATH) and other facilities within the Ghana Health Service (GHS).

It is funded by KNUST in collaboration with the Ghana Health Service and the Centre for Plant Medicine Research (CPMR) at Mampong Akuapem.

Clinical trials approval

The Food and Drugs Authority (FDA) approved the CS herbal medicine locally known as Nibima for clinical trials for COVID-19.

These trials will be conducted at two sites following the approval granted in January 2021.

In a statement, The FDA 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″.

“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.”

The Authority added that it gave the authorization after “detailed assessment” explaining that it did so under (Section 150-166) of the Public Health Act 2012 (Act 851).

Source: citinewsroom

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