The biggest cannabis medicinal clinical trial in South Africa is conducted by a research facility called BioData.The trial is being led by Dr. Shiksha Gallow as the principal investigator.
In this week’s Business of Health Gisele Wertheim Aymes spoke to Dr. Shiksha Gallow, the Medical Director of BioData about this groundbreaking clinical trial. BioData is a division of Labat Health in partnership with ONQ Clinical Research Organization and Medical Cannabis S.A.
“Bio Data about a month ago, we just received, the first farmers’ ethics approval for the first medical cannabis study in South Africa, which is really exciting and huge. We look at the use of cannabis for pain management and that’s what biodata is currently doing”. Dr Shiksha Gallow
Medicinal Cannabis in South Africa
The clinical trial seeks to understand the side effects of cannabis used in pain management, anxiety, and stress disorders. Innumerable benefits are resulting from this research; practitioners and researchers alike are anxiously waiting.
“There’s a lot of studies that’s been done. I’ve actually been working with my partners in Canada, who did a similar study as well. What we wanted to look at in a South African context, using the South African population and just getting enough information. It’s important to research so doctors and scientists can evaluate the potential, benefits, and harm of the medication.
As you know with cannabis there’s a huge stigma attached to it. Would it be banned previously and doctors are resistant to prescribing it as they don’t know enough about it? So, by doing a study like this that is proudly South African, our doctors will see. Here’s a study that was done; this is what our population looks like in regards to pain management. Does it work? Doesn’t it work? And they will feel less uncertain about the medicine and they will show them further recent evidence in South Africa”.
The aforementioned research project will also identify viable alternative pain, stress, and anxiety treatment avenues that can not only benefit the well-being and wellness of South Africans, but most importantly which can contribute billions to the country’s gross domestic product (GDP) in agricultural and health services revenue generated by the accredited SAHPRA facilities and service providers.
The medical cannabis real-world evidence study will be based on 1000 participants; in which their personal medicinal cannabis usage will be observed over a certain time frame. Participants in the study will be able to access a wide range of medical cannabis flowers and oils that have consistent genetic, chemical, cannabinoid, and terpene profiles, which will address ongoing concerns with anecdotal evidence.
Dr Gallow explained:
“We’re looking to recruit 1000 patients and of those 1000 patients, we are looking at full visits for us to collate the results for the entire year. So, we’d obviously recruit patients within the year and have a group of doctors, there are about six doctors that will be prescribing medical cannabis-specific for each patient. The treatment protocol we call micro-dosing will be specific to each patient based on their tolerance and pain levels. They’ll have to fill in questionnaires and evaluate all that data and write everything up and provide reports”
The future of medical cannabis
The envisaged objective of this clinical trial project is to help South Africans gain legal access to medicinal cannabis for personal usage and consumption. This will mostly occur from South African Health Products Authority accredited facilities as part of the pain management process.
Watch The Video
The video interview contains the full dialogue of this interview, and you can watch it below.