Ugandan-made herbal medicines pass clinical trials - govt scientists

Tazcov, one of the herbal medicines, was developed by scientists from Busitema University, while Vidicine was made by a renowned manufacturer of herbal medicines, Kazire.

Dr Monica Musenero, the Minister of Science, Technology, and Innovation, who was accompanied by researchers, told journalists in Kampala yesterday that the products were tested between March 2023 and July 2024, among 510 adult study volunteers.

The minister explained that the government-funded investigations were done by independent scientists in the country and the products have the potential to manage acute respiratory illnesses.

Uganda registers about 14 million cases of such illnesses annually.

The minister did not reveal the amount of money the government spent to conduct the trials.

"The Phase 2A clinical trial, conducted from March 2023 to July 2024, involved 510 participants aged 18 years and above across nine (9) public health facilities in Kampala who were randomly assigned to receive either the Standard of Care (SOC) alone, SOC+ IMP1 (IMP= Investigational Medicinal Product) or SOC+IMP2,’’ Dr Musenero said

"The study aimed to evaluate the safety and efficacy of these herbal medicines in resolving symptoms and clearing viruses associated with acute respiratory illnesses, including Influenza Type A and B, Covid-19, and Respiratory Syncytial Virus," she added.

The minister also revealed that the researchers found that those who used the products took four days to recover, while for those who used the standard of care, the symptoms resolved after six days. She added that the products cleared the viruses responsible for respiratory illness and the majority of participants did not experience side effects.

In Uganda, like other African countries, herbal medicines remain largely unstandardised and poorly packaged, with some also adulterated with synthetic drugs, according to information from the scientists and the National Drug Authority. Some people also link the products to witchcraft.

As a result, Dr Musenero noted that many herbalists rely on herbal medicines "solely for subsistence", and yet the global market for natural therapeutics (herbal medicines) is highly valued.

A large number of medicinal concoctions derived from medicinal plants have been traditionally used within Ugandan communities, with knowledge passed down through generations.

"Clinical trials aim to bridge this gap by providing scientific validation of herbal remedies, standardising production processes, and improving packaging. When proven effective, these efforts now open new economic opportunities, generate revenue for the country, and enable herbalists to transition from subsistence to commercial production," Dr Musenero said.

The products had already been notified by the National Drug Authority (NDA), an initial approval (marketing authorisation) which the authority gives for local herbal medicines after safety assessment as the products await clinical trials. Notified products are sold as supportive treatment and may not be called a cure.

Trials body

Yesterday’s announcement followed the establishment of the Clinical Trial of Natural Therapeutics (CONAT) platform, which the government and scientists set up to allow for the standardisation of herbal medicines and improve the general health of Ugandans.

CONAT undertakes clinical trials for the "safety, pharmacokinetics (how the body interacts with a drug), efficacy, and effectiveness of herbal medicines".

CONAT is hosted at the Makerere University Lung Institute (MLI), Kampala, Uganda. It has some of the country's leading scientists, such as Prof Pauline Byakika, the Vice Chancellor of Mbarara University of Science and Technology, Prof Bruce Kirenga, the MLI director, and Dr Moses Ocan, the lecturer of Pharmacology and Graduate Coordinator at the Department of Pharmacology and Therapeutics of Makerere University College of Health Sciences.

Dr Ocan told this publication that the results would be published in a scientific journal following the latest announcement by the government.

Dr Musenero said any herbalists willing to have their products tested can approach them. 

WHAT THE TRIAL ENTAILS

Prof Bruce Kirenga, the director of Makerere University Lung Institute, who also doubles as the lead investigator in the trials, said before the product is tried in humans, it has to undergo pre-clinical studies. 

“This includes the assessment of the compounds of the product. This work is done by the Directorate of Government Analytical Laboratory (DGAL),” Prof Kirenga said. “When you give us a product, we have to check what compounds are present. After checking, we examine what those compounds do from the available literature. “Once we correlate the compounds to the literature, we then have some evidence that the product will work. 

Then we now look at your preclinical data – that is the animal studies data, which is done at Makerere University College of Veterinary Medicine, Animal Resources and Biosecurity,” he added. After, he says the product is tested directly on the target infectious agents, such as Coronavirus, in the laboratory to see whether it will kill them. “There is no need to try it on human beings if the virus does not die,’’ Prof Kirenga said. 

For those that pass the test, Prof Kirenga explained that they are convinced the product will work and they risk trying it on human beings in phase 1 trials. “In phase one, you try it on healthy volunteers, people who do not have the target disease. This is to find the safety but also to determine the dose that is enough to kill the pathogen or cure the patient. This requires 15 to 20 people,” he said. 

“In phase two, we start now to look at preliminary efficacy – the usefulness of the drug. In this case, we could go up to 100 or 150 participants. Then we go to phase three, which is a large clinical trial when we now know that the product is likely to work,” he added. However, for Tazcov and Vidicine, Prof Kirenga revealed that they skipped some of the steps because the products were already being used.