Research Project
Medical Cannabis Through Clinical Trials”
BioData Research Project Terms and Conditions
1) Crowdfunding terms and conditions
The Study shall be funded with funds raised via a non-investment, reward based, crowdfunding model (“the Crowdfunding Model”). A successful applicant and Participating Patient will be rewarded with Medical Cannabis for his/her monthly contribution as detailed herein.
1.2 A once off non - refundable administration fee of R150 (one hundred and fifty rand) shall be payable by you before this application can be processed.
A monthly contribution towards the Crowdfunding Model of R1100 (one thousand one hundred rand) shall be payable by a participating patient who shall, in turn be rewarded with a SAHPRA approved medical cannabis research package.
1.4 Failure to effect the monthly contribution towards the Crowdfunding Model will result in non-delivery of the associated monthly reward.
1.5 A Participating Patient’s participation in the Study and consequent contribution to the Crowdfunding Model can be terminated by either party at any time on written notice to the other party. Should a Participating Patient wish to so terminate, notice may be sent to: info@biodataresearch.co.za.
1.6 Patients will be reimbursed R150 for their time.
2) Data Protection
2.1 The Sponsors and Investigators will only use the Participating Patient’s personal information as set out in the Study or as required by applicable regulations. The Sponsors and Investigators may disclose personal information to their service providers and agents under confidentiality agreements.
2.2 The Sponsors and Investigators will retain personal information for as long as necessary, having regard to applicable legislation.
2.3 A Participating Patient has a right to access personal data held by the Sponsors and Investigators. A copy of such personal data may be requested on payment of a fee determined by the Sponsors and Investigators.
2.4 The Sponsors and Investigators may transfer a Participating Patient’s personal data to or process it in other countries thathave equivalent data protection legislation to that in South Africa. The Sponsors and Investigators shall use reasonable measures to ensure that personal data, is protected to standards that are applicable in South Africa.
2.5 With the Participating Patients’ consent, the Sponsors, Investigators and their agents and service providers, will use personal information:
2.6 to comply with legal or regulatory obligations;
2.7 to perform applicable checks and conduct the relationship with you; and
2.8 for analysis, marketing (to which you have not opted out), research assessment.
2.9 The Sponsors and Investigators will treat personal information as confidential and not disclose it to third parties, except:
- where legally compelled to do so;
- where a public duty to disclose exists;
- where the interests of the Sponsors or Investigators require disclosure; or
- where disclosure is made at your request or with your consent.
2.10 The Sponsors and Investigators shall not be liable for any loss or damage where information is disclosed or withheld pursuant to lawful order or otherwise in accordance with applicable
legislation.
3) Terms & Conditions in
In respect of the Study
Project Title: To investigate the replacement of Opioids with Medical Cannabis for pain management within the South African population.
“Investigator(s)”: (Principal Investigator) Dr Shiksha Gallow
(Co- Principal Investigator) Dr Regina Hurley
(Other Investigators) Dr Ahmed Jamaloodeen, Dr Omphemetse Mathibe, Dr Xavagne Leigh Fransman, & Dr Marian Tupy
“Study” shall mean all action required to be taken and necessary to be performed by the Investigators and Sponsors)/(in determining the effects of opioid use vs medical cannabis use on quality of life in respect of patients suffering from chronic pain).If you would like more information about the goals or scientific aspects of this Study please contact info@biodataresearch.co.za.
“Participating Patient/s” shall mean a patient/s participating in this Study on a voluntary and application only basis, completely out of their own free will after having fully considered, understood and accepted any potential benefits and risks that may be associated with the Study.
3.1 Purpose: The purpose of this Study is to examine, over a period of 12 months, the difference in opiate use patterns and its effects on the quality of life in Participating Patients suffering from chronic pain, by replacing the opioids with medical cannabis.
The purpose of this Study is to examine, over a period of 12 months, the difference in the quality of life and effects on chronic pain levels of Participating Patients, by using medical cannabis as an alternative to traditional opioid use.
Participating Patients shall be treated and managed by the doctor specifically assigned and communicated to them by the Investigator. The doctors are located at any 1 of 5 sites in South Africa namely: Kwazulu Natal, Gauteng, Eastern Cape, Western Cape or Mpumalanga. All of the communication will be done online due to Covid-19 regulations.
There will be a total of 1000 Participating Patients. Patients will be recruited from all 5 sites.
The “Sponsors” of this Study are Labat Africa, a JSE listed organization.
3.2 Study Procedure: Once an application to be a Participating Patient has been reviewed and accepted by the Sponsors and Investigators, in their sole discretion and according to acceptance criteria determined by them in their sole and absolute discretion, and the Participating Patient has completed, signed and provided all documentation and information necessary and as may be required in terms of the Study and any applicable law or legislation the Participating Patient will be required to complete six questionnaires during an initial assessment which shall determine the medical cannabis prescription requirements of a particular Participating Patient.
The Participating Patient will be required to answer questions in respect of, amongst others, his/her socio-demographic data, cannabis usage history and patterns, primary pain conditions, opioid dosage and usage, pain metrics and quality of life.
Over the duration of the Study and excluding the initial assessment, a Participating Patient will be required to answer questions as determined by the Sponsors and Investigators in respect of, amongst others, his/her opioid dosage and usage, pain metrics, and quality of life.
3.3 “Risks & Discomforts”: As is the case with the trial of any new medication or similar study, there are a number of potential risks, discomforts and side effects that may be associated with the use of medical cannabis and consequently by participating in this Study which are noted hereunder.
3.4 “Potential Side Effects” may include but are not limited to: drowsiness, light-headedness, confusion, disorientation, loss of co-ordination, fainting, dizziness, increased or decreased heartbeat, loss of contact with reality, headache, nervousness, panic attacks, paranoia, hallucinations, inability to maintain balance, throat irritation, nausea, vomiting.
Long term medical cannabis use may: trigger or aggravate a pre-existing mood disorder (whether known or unknown to the Participating Patient), reduce fertility, lead to higher tolerance or cause addiction and ceasing use of cannabis after long terms use could cause withdrawal symptoms.
3.5 Drug Interactions: Medical cannabis use may affect the interaction of other medications.
The use of cannabis and resultant effects of its active component Tetrahydrocannabinol (“THC”) may be increased by the use of and when combined with certain antidepressants (Fluoxetine, Fluvoxamine, Nefazodone), antacids (Cimetidine, Omeprazole), antibiotics (Clarithromycin, Erythromycin), anti-fungals (Itraconazole, Fluconazole, Ketoconazole, Miconazole), calcium channel blockers used for high blood pressure and heart disease (Diltiazem, Verapamil), HIV protease inhibitors (Ritonavir) Amiodarone, and Isoniazid.
Other drugs that may mitigate the effects of THC include but are not limited to: Rifampicin, Carbamazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Troglitazone, and Saint John’s Wort.
3.6 WARNING: Women capable of bearing children shall be responsible for following strict contraceptive measures while participating in this Study. If a Participating Patient falls pregnant during the Study, she is required to notify the Investigators immediately. Participating in this study could potentially increase risk or harm to an unborn baby.
3.7 Benefits: Any potential benefits associated with this Study are not yet known and determining benefits associated with the use of medical cannabis for the purposes of chronic pain relief forms part of the Purpose of the Study.
3.7 Privacy & Confidentiality: Your information will be stored in a PIPA (Personal Information Protection Act) compliant electronic medical record system.
The treating physician will have access to your electronic chart.
All access to patient charts is logged and stored. Your name or any other identifying or private information will not be shared with others without your permission, nor will it appear in any reports or articles published as a result of this study. You will be given a unique anonymous identifier for data tracking.
3.8 Conflicts Of Interest: Several parties involved in this Study may reasonably be perceived to have conflicts of interest relating to the outcomes of this Study.
The Sponsors are all actively engaged in the medical cannabis industry and may materially benefit or be harmed by the results of this Study.
The results of this Study will not be sold or commercialized in any way.
3.9 Withdrawal/Removal from the Study: A Participating Patient may withdraw from participating in the Study at any time for any reason and without consequence.
The Sponsors or the Investigators may revoke a Participating Patient’s approval to participate in the Study and consequently remove such Participating Patient from the Study at any time, for any reason and without consequence.
3.10 Compensation: There shall be no monetary or other form of compensation payable to a Participating Patient for participating in the Study, rather, the medical cannabis prescribed and provided to a Participating Patient in connection with this Study shall be in accordance with the crowdfunding option selected by a Participating Patient.
If you have any ethical concerns relating to this Study, please contact the Chair of the Research Ethics Board at SAHPRA ethics@sahpra.co.za.
3.11 Informed Consent: By signing below you acknowledge the risks associated with medicinal cannabis. Additionally, you agree to give the Biodata research team informed consent to access the following:
- Anonymous information from the following questionnaires.
- Medical history, cannabis usage, and sociodemographic.
- Opioid Dosage - current opiate dosage, measured (or converted) in morphine equivalents based on McMaster University Opiate Manager.
- Brief Pain Inventory (BPI).
- EQ-5D on quality of life.
- Pharmaceutical records on opiate usage for duration of the study.
About the BIODATA
Research Project
A progressive venture between Biodata (A division of Labat Healthcare), Medical Cannabis SA and ONQ Clinical Research Organisation will commence a research project to develop relevant data in support of its future clinical trials for pain management, anxiety and sleep disorders. “It’s being called South Africa’s first real-world study of medical cannabis and researchers at Biodata, ONQ Clinical Research Organisation and Medical Cannabis SA predict that it will provide much-needed insight into the link between cannabis genetics and patient outcomes".
Led by Dr. Shiksha Gallow the principal investigator, the medical cannabis real-world evidence (MC-RWE) study will involve a minimum of 1,000 participants whose medical cannabis use will be observed over a period of time. It is further predicted that the research project will be extended to a significantly increased sample size should the initial results show a high level of success. Participants in the study will be able to access a range of medical cannabis flower and oils that have consistent genetic, chemical, cannabinoid, and terpene profiles, which will address an ongoing issue with anecdotal evidence.
Biodata will conduct the research by way of a Crowd Funded Project and the aim is to create funding to support the costs of running the research program which will assist with creating substantial observational and case studies data and to fund future clinical trials. The resultant outcome would be to ensure legal access to natural occurring medicines like cannabis to the South African public as a whole.
All cannabis is sourced from fully compliant South African Health Products Authority approved and licensed facilities.
Our Team of Medical Professionals
Principle Investigators
Dr Shiksha Gallow
Principle Investigator
Dr Gallow is the Medical Director and Clinical Trial Executive of Biodata which is part of the JSE listed Labat Healthcare. She has vast academic qualifications in both the medical sector, public health and strategic management.
Dr Gallow is registered with the HPCSA in Clinical Pathology as a Medical Scientist. She is also a registered Professional Natural Scientist with the SACNASP. Additionally, Dr Gallow is registered as an Ethnomedicine Medical Practitioner with EPASA as well as an Ayurvedic Practitioner and is also a registered Dr with the ANHA. Furthermore, Dr Gallow is a Medical Cannabis Practitioner registered with the Society of Cannabis Clinicians in the UK.
She holds a Masters Degree in Medical Science (MMedSci), a Masters in Medicine in Public Health Medicine (MMed MPH), Masters in Business Admin (MBA), and a PHD. She is currently completing a second PHD in the health profession with cannabinoids and prostate cancer. Furthermore, she completed her Clinical Pathology medical board exam Cum Laude (the most distinguished in the country of South Africa at the time). She has also completed a Medical Cannabis accredited qualification with the University of Washington Medical School, and has completed her Diploma in Medical Cannabis with Centre of Excellence Cum Laude. The Universities she obtained her degrees include, Durban University, University of Roehampton UK, Open University UK, Milton Keynes University UK, University of Washington Medical School, UNISA and the MBA was affiliated with Milton Keynes University UK. To add to her educational profile Dr Gallow is also a qualified trainer, assessor and moderator with SETA and ETDP SAQA, as well as a Prince 2 Practitioner registered with APMG. Dr Gallow has also recently published two academic books internationally one in the field of Medicine and the other in Business Science. She has published many articles in various journals, in the health, medicine and business sciences.
Dr Regina Hurley
Co-Principle Investigator
Dr Hurley is an American Board-Certified Anesthesiologist, Fellowship American Pediatric Anesthesiologist and American State Licensed Medical Cannabis Physician as well as South African HPCSA Registered Specialist Anesthesiologist, former HOD Amajuba district anesthesia Department, Current practicing anesthesiologist at Mediclinic and Chairperson Hospital Clinical Performance Committee Mediclinic. Dr Hurley’s cannabis lectures are accredited by the South African Medical Association for educating other professionals. She is a previous Cannabis Expo Speaker and has been featured in numerous newspaper articles and educational blogs.
Investigators
Dr. Sello Seahloli
Executive Director of ONQ research
Dr Seahloli has over 20 years’ experience in the clinical research field and medical writing. He started his career in 1995 with Schering Plough South Africa in medical / pharmaceutical marketing and clinical research. Dr Seahloli holds a B.Sc. in Medical Sciences specialising in Haematology, M.Sc. degree in Medicine specialising in Haemato-Oncology and a Ph.D. in clinical research. Dr Seahloli was a member of the Association of Clinical Research Professionals, Washington DC. and is currently a member of the South African Clinical Research Association and Med Bay.
Dr Ahmed Jamaloodeen
Registered HPCSA Medical Doctor
Dr Jamaloodeen is a registered HPCSA Medical Doctor in South Africa and is Director of various companies across various sectors. Dr Jamaloodeen is a permitted hemp farmer in Newcastle in KZN practicing eco-farming and organic farming on 5000 hectares using the latest technology and artificial intelligence. Dr Jamaloodeen is the National Treasurer of CDCSA, Vice -Treasurer of CSCKZN and an AFASA member
Dr. Omphemetse Mathibe
MBChB (UP)
A trusted, high performing and experienced clinician with a history of serving patients by successfully diagnosing, treating and managing diseases and complications, with a particular interest in obstetrics and gynaecology, and critical care. Disciplined and confident by nature with extensive experience in hospital and clinical settings.
Dr. Xavagne Leigh Fransman
MBCHB UFS
A dependable and well-rounded clinician with excellent patient rapport. Experienced in both the public and private sector, successfully diagnosing and treating a wide variety of patients while maintaining unwavering professionalism and care. Passionate about women’s health, emergency medicine and the incorporation of safe, registered medical cannabis products in everyday clinical medicine.
Dr Marian Tupy
Medical Doctor: Surgeon
Dr Marian Tupy is a registered medical doctor with the HPCSA. He is a specialist surgeon in Urology. Dr Tupy has obtained his PHD in Urology at the Komensky University in Slovakia. He has many years of experience in medicine and surgery. He has experience in medical cannabis and treating patients with cannabinoids and is registered with the American Medical Marijuana Physicians Association. He is one of the investigators in this Observation Trial, and has a section 21 license with SAHPRA for medical cannabinoids.
Why become a
research participant
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Would you like to explore the possibilities of using cannabis plant material and oils to help manage chronic pain, insomnia, anxiety etc.
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Are you buying untested and potentially toxic cannabis plant material from questionable and/or unreliable sources?
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Would you like to participate in a sanctioned cannabis research project to help develop substantial observational data for the future clinical trials.
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Would you like to obtain premium cannabis from legal and regulated sources on a monthly basis to see if it will assist with your ailment or conditions?
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Do you want access to a qualified and knowledgeable resource to assist with your cannabis use?
Biodata, together with Medical cannabis SA, is offering South African patients the opportunity to register to be a part of this ground-breaking clinical cannabis trial It’s being called South Africa’s first real-world study of medical cannabis, and researchers at Biodata and Medical Cannabis SA predict that it will provide much-needed insight into the link between cannabis genetics and patient outcomes. All cannabis is sourced from fully compliant SAHPRA licensed facilities.
How to become
a research participant
Application
Our team of medical doctors and scientists will evaluate your application to see if you qualify.
Your research number will be a unique way to access the research portal where you can view the different package options, choose your package, fill out questionnaires, make payments and change/update your details if needed.
There are two packages available 1. Medicinal cannabis flower 2. Medicinal cannabis oil. Strain information, COA (Certificate of Analysis) and usage instructions will be available.
Research Packages and
Crowdfunding Contributions
Research Package 1
as prescribed by the doctor
Each compartment contains 0.5 grams of flower
Organically grown in a SAHPRA approved facility.
Research Package 2
Crowdfunding Explained
Crowdfunding is a way to raise funds for a specific cause or project by asking a large number of people to donate money, usually in small amounts, and usually over a period of time. This can also be conducted by way of a subscription. In a new industry such as the Cannabis industry, many countries have followed this model for research due to the large costs of a clinical trial.
It is Biodata’s intention to raise capital via this route, to not only fund part of the research project but to create a fund for controlled and authorised clinical trials. The crowd funders have a mutual interest of ensuring thatCannabis takes it rightful place as a legal and legitimate medicine into the future. The narrative driving the crowdfunding approach is thus to ensure successful implementation of Cannabis and Cannabis products (including THC) as aTraditional Medicine, which is compliant with all regulatory and legal compliances under the Medicines act and the Drug Trafficking act. The crowd investment is per the above narrative and the return on investment is the legitimisation of Cannabis flower and cannabis oils and the replacement product for highly addictive and dangerous opiates for medicinal purposes without legal interference.
It is anticipated that the fund will be requesting a monthly investment of R1150 per month from individuals who are interested to invest in their health and the research. The funds will be used to finance the research activities, clinical trials, medical expenses and the administrative costs associated with the normal cost of research operations. Crowdfunding pre-clinical studies is not anew concept and has successfully been used all over Europe. One of the major successes relates to patients with certain disease sufferers like the Oncolytic Virus for patients with Neuroendocrine Tumors. Over R50 Million was raised by family participants of disease sufferers (Nat Med. 2015:21:101-102)
The growing popularity of crowdfunding is a testimony for its successfulness and usefulness in terms of clinical trials. Some of the advantages include:
· Public Interaction – In this regard, Catherine Ferguson, Innovation Project Lead andCancer Research UK, points out that; “One key thing is tangibility. It’s an inherent part of crowdfunding that isn’t inherent in regular funding.” She also adds that, Crowdfunding enables a “more direct relationship with both the researchers and the research.” In addition to this, crowdfunding also enables researchers to create close relationships with donors and can engage with thousands of people on a regular basis.
· Ease and Efficiency – Spreading the idea and the perspectives of clinical studies can be daunting. And when gaining publicity is important for a project to receive sponsorships and donations, crowdfunding can really accelerate the whole process. As a Result, more people will be able to find out about the goals of the research campaign and, therefore, will be able to contribute financially as much as they can.
· Cost-Effectiveness – Additional costs is something that any research company wants to avoid when looking for sponsors. Especially when trials themselves are quite costly.In consequence, using crowdfunding platforms offers cost-efficient ways of finding donors and people ready to support the trial.
· Goal – This process will not only create additional awareness of the benefits of Cannabis, but it will show the public support for the legitimisation of Cannabis as areal replacement for the dangerous opiates on the market currently.
BioData Research Project Terms and Conditions
1) Crowdfunding terms and conditions
The Study shall be funded with funds raised via a non-investment, reward based, crowdfunding model (“the Crowdfunding Model”). A successful applicant and Participating Patient will be rewarded with Medical Cannabis for his/her monthly contribution as detailed herein.
1.2 A once off non - refundable administration fee of R150 (one hundred and fifty rand) shall be payable by you before this application can be processed.
A monthly contribution towards the Crowdfunding Model of R1100 (one thousand one hundred rand) shall be payable by a participating patient who shall, in turn be rewarded with a SAHPRA approved medical cannabis research package.
1.4 Failure to effect the monthly contribution towards the Crowdfunding Model will result in non-delivery of the associated monthly reward.
1.5 A Participating Patient’s participation in the Study and consequent contribution to the Crowdfunding Model can be terminated by either party at any time on written notice to the other party. Should a Participating Patient wish to so terminate, notice may be sent to: info@biodataresearch.co.za.
1.6 Patients will be reimbursed R150 for their time.
2) Data Protection
2.1 The Sponsors and Investigators will only use the Participating Patient’s personal information as set out in the Study or as required by applicable regulations. The Sponsors and Investigators may disclose personal information to their service providers and agents under confidentiality agreements.
2.2 The Sponsors and Investigators will retain personal information for as long as necessary, having regard to applicable legislation.
2.3 A Participating Patient has a right to access personal data held by the Sponsors and Investigators. A copy of such personal data may be requested on payment of a fee determined by the Sponsors and Investigators.
2.4 The Sponsors and Investigators may transfer a Participating Patient’s personal data to or process it in other countries thathave equivalent data protection legislation to that in South Africa. The Sponsors and Investigators shall use reasonable measures to ensure that personal data, is protected to standards that are applicable in South Africa.
2.5 With the Participating Patients’ consent, the Sponsors, Investigators and their agents and service providers, will use personal information:
2.6 to comply with legal or regulatory obligations;
2.7 to perform applicable checks and conduct the relationship with you; and
2.8 for analysis, marketing (to which you have not opted out), research assessment.
2.9 The Sponsors and Investigators will treat personal information as confidential and not disclose it to third parties, except:
- where legally compelled to do so;
- where a public duty to disclose exists;
- where the interests of the Sponsors or Investigators require disclosure; or
- where disclosure is made at your request or with your consent.
2.10 The Sponsors and Investigators shall not be liable for any loss or damage where information is disclosed or withheld pursuant to lawful order or otherwise in accordance with applicable
legislation.
3) Terms & Conditions in
In respect of the Study
Project Title: To investigate the replacement of Opioids with Medical Cannabis for pain management within the South African population.
“Investigator(s)”: (Principal Investigator) Dr Shiksha Gallow
(Co- Principal Investigator) Dr Regina Hurley
(Other Investigators) Dr Ahmed Jamaloodeen, Dr Omphemetse Mathibe, Dr Xavagne Leigh Fransman, & Dr Marian Tupy
“Study” shall mean all action required to be taken and necessary to be performed by the Investigators and Sponsors)/(in determining the effects of opioid use vs medical cannabis use on quality of life in respect of patients suffering from chronic pain).If you would like more information about the goals or scientific aspects of this Study please contact info@biodataresearch.co.za.
“Participating Patient/s” shall mean a patient/s participating in this Study on a voluntary and application only basis, completely out of their own free will after having fully considered, understood and accepted any potential benefits and risks that may be associated with the Study.
3.1 Purpose: The purpose of this Study is to examine, over a period of 12 months, the difference in opiate use patterns and its effects on the quality of life in Participating Patients suffering from chronic pain, by replacing the opioids with medical cannabis.
The purpose of this Study is to examine, over a period of 12 months, the difference in the quality of life and effects on chronic pain levels of Participating Patients, by using medical cannabis as an alternative to traditional opioid use.
Participating Patients shall be treated and managed by the doctor specifically assigned and communicated to them by the Investigator. The doctors are located at any 1 of 5 sites in South Africa namely: Kwazulu Natal, Gauteng, Eastern Cape, Western Cape or Mpumalanga. All of the communication will be done online due to Covid-19 regulations.
There will be a total of 1000 Participating Patients. Patients will be recruited from all 5 sites.
The “Sponsors” of this Study are Labat Africa, a JSE listed organization.
3.2 Study Procedure: Once an application to be a Participating Patient has been reviewed and accepted by the Sponsors and Investigators, in their sole discretion and according to acceptance criteria determined by them in their sole and absolute discretion, and the Participating Patient has completed, signed and provided all documentation and information necessary and as may be required in terms of the Study and any applicable law or legislation the Participating Patient will be required to complete six questionnaires during an initial assessment which shall determine the medical cannabis prescription requirements of a particular Participating Patient.
The Participating Patient will be required to answer questions in respect of, amongst others, his/her socio-demographic data, cannabis usage history and patterns, primary pain conditions, opioid dosage and usage, pain metrics and quality of life.
Over the duration of the Study and excluding the initial assessment, a Participating Patient will be required to answer questions as determined by the Sponsors and Investigators in respect of, amongst others, his/her opioid dosage and usage, pain metrics, and quality of life.
3.3 “Risks & Discomforts”: As is the case with the trial of any new medication or similar study, there are a number of potential risks, discomforts and side effects that may be associated with the use of medical cannabis and consequently by participating in this Study which are noted hereunder.
3.4 “Potential Side Effects” may include but are not limited to: drowsiness, light-headedness, confusion, disorientation, loss of co-ordination, fainting, dizziness, increased or decreased heartbeat, loss of contact with reality, headache, nervousness, panic attacks, paranoia, hallucinations, inability to maintain balance, throat irritation, nausea, vomiting.
Long term medical cannabis use may: trigger or aggravate a pre-existing mood disorder (whether known or unknown to the Participating Patient), reduce fertility, lead to higher tolerance or cause addiction and ceasing use of cannabis after long terms use could cause withdrawal symptoms.
3.5 Drug Interactions: Medical cannabis use may affect the interaction of other medications.
The use of cannabis and resultant effects of its active component Tetrahydrocannabinol (“THC”) may be increased by the use of and when combined with certain antidepressants (Fluoxetine, Fluvoxamine, Nefazodone), antacids (Cimetidine, Omeprazole), antibiotics (Clarithromycin, Erythromycin), anti-fungals (Itraconazole, Fluconazole, Ketoconazole, Miconazole), calcium channel blockers used for high blood pressure and heart disease (Diltiazem, Verapamil), HIV protease inhibitors (Ritonavir) Amiodarone, and Isoniazid.
Other drugs that may mitigate the effects of THC include but are not limited to: Rifampicin, Carbamazepine, Phenobarbital, Phenytoin, Primidone, Rifabutin, Troglitazone, and Saint John’s Wort.
3.6 WARNING: Women capable of bearing children shall be responsible for following strict contraceptive measures while participating in this Study. If a Participating Patient falls pregnant during the Study, she is required to notify the Investigators immediately. Participating in this study could potentially increase risk or harm to an unborn baby.
3.7 Benefits: Any potential benefits associated with this Study are not yet known and determining benefits associated with the use of medical cannabis for the purposes of chronic pain relief forms part of the Purpose of the Study.
3.7 Privacy & Confidentiality: Your information will be stored in a PIPA (Personal Information Protection Act) compliant electronic medical record system.
The treating physician will have access to your electronic chart.
All access to patient charts is logged and stored. Your name or any other identifying or private information will not be shared with others without your permission, nor will it appear in any reports or articles published as a result of this study. You will be given a unique anonymous identifier for data tracking.
3.8 Conflicts Of Interest: Several parties involved in this Study may reasonably be perceived to have conflicts of interest relating to the outcomes of this Study.
The Sponsors are all actively engaged in the medical cannabis industry and may materially benefit or be harmed by the results of this Study.
The results of this Study will not be sold or commercialized in any way.
3.9 Withdrawal/Removal from the Study: A Participating Patient may withdraw from participating in the Study at any time for any reason and without consequence.
The Sponsors or the Investigators may revoke a Participating Patient’s approval to participate in the Study and consequently remove such Participating Patient from the Study at any time, for any reason and without consequence.
3.10 Compensation: There shall be no monetary or other form of compensation payable to a Participating Patient for participating in the Study, rather, the medical cannabis prescribed and provided to a Participating Patient in connection with this Study shall be in accordance with the crowdfunding option selected by a Participating Patient.
If you have any ethical concerns relating to this Study, please contact the Chair of the Research Ethics Board at SAHPRA ethics@sahpra.co.za.
3.11 Informed Consent: By signing below you acknowledge the risks associated with medicinal cannabis. Additionally, you agree to give the Biodata research team informed consent to access the following:
- Anonymous information from the following questionnaires.
- Medical history, cannabis usage, and sociodemographic.
- Opioid Dosage - current opiate dosage, measured (or converted) in morphine equivalents based on McMaster University Opiate Manager.
- Brief Pain Inventory (BPI).
- EQ-5D on quality of life.
- Pharmaceutical records on opiate usage for duration of the study.
About the BIODATA
Research Project
A progressive venture between Biodata (A division of Labat Healthcare), Medical Cannabis SA and ONQ Clinical Research Organisation will commence a research project to develop relevant data in support of its future clinical trials for pain management, anxiety and sleep disorders. “It’s being called South Africa’s first real-world study of medical cannabis and researchers at Biodata, ONQ Clinical Research Organisation and Medical Cannabis SA predict that it will provide much-needed insight into the link between cannabis genetics and patient outcomes".
Led by Dr. Shiksha Gallow the principal investigator, the medical cannabis real-world evidence (MC-RWE) study will involve a minimum of 1,000 participants whose medical cannabis use will be observed over a period of time. It is further predicted that the research project will be extended to a significantly increased sample size should the initial results show a high level of success. Participants in the study will be able to access a range of medical cannabis flower and oils that have consistent genetic, chemical, cannabinoid, and terpene profiles, which will address an ongoing issue with anecdotal evidence.
Biodata will conduct the research by way of a Crowd Funded Project and the aim is to create funding to support the costs of running the research program which will assist with creating substantial observational and case studies data and to fund future clinical trials. The resultant outcome would be to ensure legal access to natural occurring medicines like cannabis to the South African public as a whole.
All cannabis is sourced from fully compliant South African Health Products Authority approved and licensed facilities.
Our Team of Medical Professionals
Principle Investigators
Dr Shiksha Gallow
Principle Investigator
Dr Gallow is the Medical Director and Clinical Trial Executive of Biodata which is part of the JSE listed Labat Healthcare. She has vast academic qualifications in both the medical sector, public health and strategic management.
Dr Gallow is registered with the HPCSA in Clinical Pathology as a Medical Scientist. She is also a registered Professional Natural Scientist with the SACNASP. Additionally, Dr Gallow is registered as an Ethnomedicine Medical Practitioner with EPASA as well as an Ayurvedic Practitioner and is also a registered Dr with the ANHA. Furthermore, Dr Gallow is a Medical Cannabis Practitioner registered with the Society of Cannabis Clinicians in the UK.
She holds a Masters Degree in Medical Science (MMedSci), a Masters in Medicine in Public Health Medicine (MMed MPH), Masters in Business Admin (MBA), and a PHD. She is currently completing a second PHD in the health profession with cannabinoids and prostate cancer. Furthermore, she completed her Clinical Pathology medical board exam Cum Laude (the most distinguished in the country of South Africa at the time). She has also completed a Medical Cannabis accredited qualification with the University of Washington Medical School, and has completed her Diploma in Medical Cannabis with Centre of Excellence Cum Laude. The Universities she obtained her degrees include, Durban University, University of Roehampton UK, Open University UK, Milton Keynes University UK, University of Washington Medical School, UNISA and the MBA was affiliated with Milton Keynes University UK. To add to her educational profile Dr Gallow is also a qualified trainer, assessor and moderator with SETA and ETDP SAQA, as well as a Prince 2 Practitioner registered with APMG. Dr Gallow has also recently published two academic books internationally one in the field of Medicine and the other in Business Science. She has published many articles in various journals, in the health, medicine and business sciences.
Dr Regina Hurley
Co-Principle Investigator
Dr Hurley is an American Board-Certified Anesthesiologist, Fellowship American Pediatric Anesthesiologist and American State Licensed Medical Cannabis Physician as well as South African HPCSA Registered Specialist Anesthesiologist, former HOD Amajuba district anesthesia Department, Current practicing anesthesiologist at Mediclinic and Chairperson Hospital Clinical Performance Committee Mediclinic. Dr Hurley’s cannabis lectures are accredited by the South African Medical Association for educating other professionals. She is a previous Cannabis Expo Speaker and has been featured in numerous newspaper articles and educational blogs.
Investigators
Dr. Sello Seahloli
Executive Director of ONQ research
Dr Seahloli has over 20 years’ experience in the clinical research field and medical writing. He started his career in 1995 with Schering Plough South Africa in medical / pharmaceutical marketing and clinical research. Dr Seahloli holds a B.Sc. in Medical Sciences specialising in Haematology, M.Sc. degree in Medicine specialising in Haemato-Oncology and a Ph.D. in clinical research. Dr Seahloli was a member of the Association of Clinical Research Professionals, Washington DC. and is currently a member of the South African Clinical Research Association and Med Bay.
Dr Ahmed Jamaloodeen
Registered HPCSA Medical Doctor
Dr Jamaloodeen is a registered HPCSA Medical Doctor in South Africa and is Director of various companies across various sectors. Dr Jamaloodeen is a permitted hemp farmer in Newcastle in KZN practicing eco-farming and organic farming on 5000 hectares using the latest technology and artificial intelligence. Dr Jamaloodeen is the National Treasurer of CDCSA, Vice -Treasurer of CSCKZN and an AFASA member
Dr. Omphemetse Mathibe
MBChB (UP)
A trusted, high performing and experienced clinician with a history of serving patients by successfully diagnosing, treating and managing diseases and complications, with a particular interest in obstetrics and gynaecology, and critical care. Disciplined and confident by nature with extensive experience in hospital and clinical settings.
Dr. Xavagne Leigh Fransman
MBCHB UFS
A dependable and well-rounded clinician with excellent patient rapport. Experienced in both the public and private sector, successfully diagnosing and treating a wide variety of patients while maintaining unwavering professionalism and care. Passionate about women’s health, emergency medicine and the incorporation of safe, registered medical cannabis products in everyday clinical medicine.
Dr Marian Tupy
Medical Doctor: Surgeon
Dr Marian Tupy is a registered medical doctor with the HPCSA. He is a specialist surgeon in Urology. Dr Tupy has obtained his PHD in Urology at the Komensky University in Slovakia. He has many years of experience in medicine and surgery. He has experience in medical cannabis and treating patients with cannabinoids and is registered with the American Medical Marijuana Physicians Association. He is one of the investigators in this Observation Trial, and has a section 21 license with SAHPRA for medical cannabinoids.
Why become a
research participant
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Would you like to explore the possibilities of using cannabis plant material and oils to help manage chronic pain, insomnia, anxiety etc.
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Are you buying untested and potentially toxic cannabis plant material from questionable and/or unreliable sources?
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Would you like to participate in a sanctioned cannabis research project to help develop substantial observational data for the future clinical trials.
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Would you like to obtain premium cannabis from legal and regulated sources on a monthly basis to see if it will assist with your ailment or conditions?
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Do you want access to a qualified and knowledgeable resource to assist with your cannabis use?
Biodata, together with Medical cannabis SA, is offering South African patients the opportunity to register to be a part of this ground-breaking clinical cannabis trial It’s being called South Africa’s first real-world study of medical cannabis, and researchers at Biodata and Medical Cannabis SA predict that it will provide much-needed insight into the link between cannabis genetics and patient outcomes. All cannabis is sourced from fully compliant SAHPRA licensed facilities.
How to become
a research participant
Application
Our team of medical doctors and scientists will evaluate your application to see if you qualify.
Your research number will be a unique way to access the research portal where you can view the different package options, choose your package, fill out questionnaires, make payments and change/update your details if needed.
There are two packages available 1. Medicinal cannabis flower 2. Medicinal cannabis oil. Strain information, COA (Certificate of Analysis) and usage instructions will be available.
Research Packages and
Crowdfunding Contributions
Research Package 1
as prescribed by the doctor
Each compartment contains 0.5 grams of flower
Organically grown in a SAHPRA approved facility.
Research Package 2
Crowdfunding Explained
Crowdfunding is a way to raise funds for a specific cause or project by asking a large number of people to donate money, usually in small amounts, and usually over a period of time. This can also be conducted by way of a subscription. In a new industry such as the Cannabis industry, many countries have followed this model for research due to the large costs of a clinical trial.
It is Biodata’s intention to raise capital via this route, to not only fund part of the research project but to create a fund for controlled and authorised clinical trials. The crowd funders have a mutual interest of ensuring thatCannabis takes it rightful place as a legal and legitimate medicine into the future. The narrative driving the crowdfunding approach is thus to ensure successful implementation of Cannabis and Cannabis products (including THC) as aTraditional Medicine, which is compliant with all regulatory and legal compliances under the Medicines act and the Drug Trafficking act. The crowd investment is per the above narrative and the return on investment is the legitimisation of Cannabis flower and cannabis oils and the replacement product for highly addictive and dangerous opiates for medicinal purposes without legal interference.
It is anticipated that the fund will be requesting a monthly investment of R1150 per month from individuals who are interested to invest in their health and the research. The funds will be used to finance the research activities, clinical trials, medical expenses and the administrative costs associated with the normal cost of research operations. Crowdfunding pre-clinical studies is not anew concept and has successfully been used all over Europe. One of the major successes relates to patients with certain disease sufferers like the Oncolytic Virus for patients with Neuroendocrine Tumors. Over R50 Million was raised by family participants of disease sufferers (Nat Med. 2015:21:101-102)
The growing popularity of crowdfunding is a testimony for its successfulness and usefulness in terms of clinical trials. Some of the advantages include:
· Public Interaction – In this regard, Catherine Ferguson, Innovation Project Lead andCancer Research UK, points out that; “One key thing is tangibility. It’s an inherent part of crowdfunding that isn’t inherent in regular funding.” She also adds that, Crowdfunding enables a “more direct relationship with both the researchers and the research.” In addition to this, crowdfunding also enables researchers to create close relationships with donors and can engage with thousands of people on a regular basis.
· Ease and Efficiency – Spreading the idea and the perspectives of clinical studies can be daunting. And when gaining publicity is important for a project to receive sponsorships and donations, crowdfunding can really accelerate the whole process. As a Result, more people will be able to find out about the goals of the research campaign and, therefore, will be able to contribute financially as much as they can.
· Cost-Effectiveness – Additional costs is something that any research company wants to avoid when looking for sponsors. Especially when trials themselves are quite costly.In consequence, using crowdfunding platforms offers cost-efficient ways of finding donors and people ready to support the trial.
· Goal – This process will not only create additional awareness of the benefits of Cannabis, but it will show the public support for the legitimisation of Cannabis as areal replacement for the dangerous opiates on the market currently.