The Department of Pharmacology at the University of the Free State (UFS) and FARMOVS have teamed up to conduct the first South African Health Products Regulatory Authority (SAHPRA)-approved multicentre controlled clinical trial of a plant-based product, PHELA, on mild to moderate COVID-19 patients.
According to Prof Motlalepula Matsabisa, professor and director of Pharmacology at UFS, it is anticipated that the trial will start in early April, with each patient being on treatment for 28 days.
“The main purpose of the clinical trial is to confirm that the product can treat COVID-19 and be registered as a medication for this indication. We believe the medication works as an immune modulator to modulate the cytokine storm due to COVID-19 and also restores and normalises the patient’s immune system. We plan to have 250 patients who suffer from mild to moderate COVID-19,” said Matsabisa.
This pivotal study, he says, is based on the modification of the World Health Organization (WHO) Master protocol for clinical trials. The use of FARMOVS, a wholly owned clinical research company of the UFS Bloemfontein campus, for this clinical trial, was to implement the collaborative initiatives between UFS and FARMOVS on clinical research, training, and other research projects.
What is PHELA?
Matsabisa, deputy president of the South African Society for Basic and Clinical Pharmacology Society (SASBCP), says the development of PHELA has been under stringent scientific scrutiny for its safety in both preclinical and clinical research. The efficacy of PHELA as both an immune modulator and an anti-SARS-COV-2 has been proven in vitro and in vivo with reproducible results conducted by three independent research institutions and a science council.
The Department of Pharmacology and FARMOVS are collaborating on a number of studies to advance clinical research on African Traditional Medicines (ATM).
On the use of PHELA, Matsabisa said: “PHELA is a herbal product made of four medicinal plants. Traditionally it has been claimed for use for a historical disease called muyaga, but recently has been scientifically tested and found effective as an immune modulator and benefiting persons with a compromised immune system.
“The PHELA plants are found in most provinces of South Africa and we have cultivated them to control their growth to produce quality raw materials.
“The SAHPRA-approved clinical trial will be conducted in the Eastern Cape, Northern Cape and Gauteng. It will be conducted by a complement of medical staff and clinicians with vast experience of many active years of clinical trials.
“The study, we believe, is a benchmark for all future traditional medicines clinical trial protocols and studies. The research is expected to start immediately after the product batch manufacturing of the study product, PHELA, is completed and this will be within a month’s time. A lot of good scientific preclinical safety and efficacy research has gone into the development of the study product for it to reach this stage.
“The efficacy studies have shown convincingly that PHELA is an immune reconstitution product and does have an effect in killing the SARS-COV-2 virus and most of its variants. PHELA efficacy, therefore, needs to be confirmed through randomised controlled multicentre clinical trials in COVID-19 patients,” Matsabisa says.
Medicinal plants previously used to eradicate life-threatening viruses
Although medicinal plants have been used to combat previous pandemics such as the Spanish flu, avian influenza and others, rigorous control and efficacy thereof is still to be supported by scientific research and development, adds Matsabisa.
Matsabisa, the current chairperson of the WHO Regional Expert Advisory Committee on Traditional Medicines (REACT), says: “We have better technologies and resources now, which is why we should take the next step in research to promote consumer safety and to offer them effective alternatives. We do the science to aid in building the herbal industry and develop sustained consumer confidence in traditional medicines.”
Africa should lead the way to a healthier future for all
He said his vision was “for Africa to share our valuable resources with the world by developing, and distributing world-class medicinal solutions”.
“We should develop and strengthen the pharmaceutical local production of well-researched, quality, safe and efficacious African traditional medicines as commercial products. We are more than capable of doing so and now is the time to do it. Numerous discussions have taken place where other African countries will join South Africa in conducting multicentre studies in clinical trials for traditional medicines.
“We need to develop or create, based on this current collaborative work with partners like FARMOVS, health centres with a strong focus on African medicines, health products and healing, but in a very strong collaborative initiative with other health systems,” he said.
Matsabisa was recently awarded a Visiting Professorship at the Beijing University of Chinese Medicine (BUCM) in China. He was also recommended to Naledi Pandor, Minister of International Relations and Cooperation, to be part of the India, Brazil and South Africa (IBSA) working group in traditional medicine through his participation in the national department of health technical committee on traditional medicines where he has been appointed by tMinister of Health Dr Joe Phaahla.
Issued by University of the Free State