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Prof Matsabisa
Prof Motlalepula Matsabisa is a professor and Director of Pharmacology at the University of the Free State (UFS)

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,” explains Prof Matsabisa. 

This pivotal study, he says, is based on the modification of the World Health Organisation (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?

Prof 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, Prof Matsabisa explains: “PHELA is a herbal product made of four medicinal plants. Traditionally PHELA 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. The clinical trial 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 studies are 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,” Prof Matsabisa says.

Medicinal plants have previously been 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, we still believe rigorous control and efficacy thereof is still to be supported by scientific research and development, says Prof Matsabisa. 

Prof Matsabisa, the current chairperson of the World Health Organisation’s (WHO) Regional Expert Advisory Committee on Traditional Medicines (REACT), adds: “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
“My vision is 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”, concludes Prof Matsabisa.

Prof Matsabisa was recently awarded a Visiting Professorship at the Beijing University of Chinese Medicine (BUCM) in Beijing, 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 the Minister of Health, Dr Joe Phaahla.

News Archive

UFS to monitor the use of ARV-drugs on pregnant women and children
2004-12-08

The University of the Free State (UFS) is to establish a Pharmacovigilance Centre that will monitor the effects of Anti-Retroviral (ARV) drugs on HIV positive pregnant women and children starting early in the new year.

The UFS is one of only two institutions chosen by the Minister of Health, Dr Manto Tshabalala-Msimang, to establish such an ARV monitoring centre.

The other centre will be based at Medical University of South Africa (MEDUNSA) and will concentrate mainly on monitoring the effects of the drugs on adults.

“The establishment of the UFS’s Pharmaconvigilance Centre forms part of government’s Comprehensive Plan on HIV and AIDS, often termed the roll-out plan for ARV drugs. The centre’s primary responsibility will be to specifically monitor the use of these drugs in pregnant women, and children under the age of 13,” said Prof Andrew Walubo of the UFS’s Department of Pharmacology.

“Although most of the side effects of ARV drugs have been identified in other countries, it has now become critical to identify the side effects amongst the South African population. This is important because many people will be exposed to the drugs within a short time. Our aim is so identify the most common side effects and make recommendations for the prevention thereof. The centre will help in detecting the risk of using anti-retroviral drugs in pregnancy and children, and prevention of adverse drug reactions,” said Prof Walubo.

According to Prof Walubo 12 drugs will be monitored – these drugs will be selected according to the patient’s profile.

The centre will comprise of two components: A pregnancy registry, which will focus on a new-born child up until two months and a pediatric registry, which will focus on children who are born of mothers who used ARV drugs and children using ARV drugs.

According to Prof Walubo, the Pharmaconvigilance Centre will also be responsible for offering relevant technical advice, training and selected research on ARV drugs in these patients.

The centre will be fully sponsored by the national Department of Health. It will be based in the UFS’s Faculty of Health Sciences, Department of Pharmacology, and will be run in collaboration with experts from different departments in the faculty.

Media release
Issued by: Lacea Loader
Media Representative
Tel: (051) 401-2584
Cell: 083 645 2454
E-mail: loaderl.stg@mail.uovs.ac.za
8 December 2004

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