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Indigenous Knowledge Systems Research Unit

 


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Indigenous Knowledge Systems Research Unit

Activities and special projects

Assessment of traditional claims for health benefits and/or cures

Why clinical trials for herbal medicines
There are many claims laid against the use of traditional medicines and such claims are used for life-threatening and chronic conditions. There are again numerous commercial products on the market without any evidence of safety and efficacy. The safety and clinical evaluation of traditional herbal medicines is aimed at value-adding of those products intended for use by the wider public. This value addition is to open up a niche commercial market for those proven products for both the local and international markets. To access these markets, the products then need to meet the minimum requirements of safety, efficacy and quality. This implies validation of the traditional medicines using sound scientific methods acceptable to international standards. 

The procedures for assessment of a health claim
The table below outlines the steps in the evaluation of traditional claims for health benefits and/or cures and estimated time frames for each process. The time frame will greatly depend on the condition/diseases being evaluated for. The time frames below are applicable to immune modulators only.

  STEP

PROCESS

APPROXIMATE TIME FRAME

1

How to contact MRC-IKS offices

Depending on a claimant

2

Sending documents to claimant

2 week

3

Meeting between the claimant and IKS

1 day

4

Send the Confidentiality Agreement   

1 month

5

Disclosure of the information

1 week

6

Literature search

1 month

7

Funding options for clinical trails

Option 1:  Own funding and MRC as a service provider
Option 2: MRC sourced funding and MRC as a partner.
Minimum evidence of health benefit would be required by the MRC or the MRC may require such data to be collected by the claimant if it is not already available. Conditions apply to qualify for this option and these would be specified by the MRC.

8

Supply of enough test material for analysis 

This will be stipulated in the contract 

9

Development of protocols

±2 months

10

Study

  1. Toxicology –Safety
  2. Phase I: Safety Study
  3. Phase II/III: Efficacy Study   

 

± 5 months
± 4 months
± 12 months

11

Meeting with investigators

1 day

12

Estimated duration of clinical trials evaluations

± 2 years

13

Publication and presentations

at the end of each phase of the evaluation 

14

Registration with the Medicines Control Council (MCC)

Once the clinical trials are done, that means when it has already been tested on several people to define its safety, effectiveness and long-term undesirable effects, it would be ready for registration, to be licensed and for commercial use. It then becomes the marketed medicine that can be sold in clinics, health shops, pharmacies, etc.

Step 1 - How to contact MRC-IKS offices 
The claimant can contact MRC-IKS offices either telephonically or via email or fax. Here are the contact details:
Tel: 021 938 0475; International +27 21 938 0475
Fax: 021 938 0410; International +27 21 938 0410
Email: thozama.spotose@mrc.ac.za
Website: http://www.mrc.ac.za/iks/indigenous.htm

The claimant can also write to us or visit our offices at the MRC Head Office in Cape Town.

Cape Town address

PHYSICAL ADDRESS
Medical Research Council - (MRC)
IKS [Health]
Francie van Zijl Drive
Parow Valley, Cape Town 

POSTAL ADDRESS
Medical Research Council - (MRC)
IKS [Health]
P.O. Box 19070
Tygerberg, 7505

Step 2 - Sending documents to claimant
The IKS will send document to the claimant explaining how traditional claims are being handled. The document will be made available to the claimant once an interest has been shown by the claimant to test the product. 

Step 3 - Meeting between the claimant and IKS 
The main purpose of this meeting is for the claimant to tell IKS her/his expectations. The other purpose is to correspond directly with the claimant to discuss the document sent to him/her and discuss other issues related to traditional claims or clinical trials. The IKS will also explain the processes involved and give the claimant an opportunity to ask questions. 

Step 4 - Confidentiality Agreement   
The confidentiality agreement is sent to the claimant for perusal and for a decision to be made if the claimant has fully understood the processes involved and has indicated an interest to proceed with the evaluation processes. If the claimant needs help regarding the agreement she/he can contact IKS, contact a lawyer of their choice at their own expense or whoever can help to explain and interpret the document. The MRC is working hard to have this document available in all 11 official languages of South Africa. If the claimant agrees with the process, the Memorandum of Agreement (MoA) will be signed by both parties. The original is returned to the MRC whereas the claimant will be given a copy. This agreement is a legal document and is binding. The MoA also requests that the claimant supplies fresh plants for planting, for identification purpose and possible cultivation for clinical trial needs. The MoA further states that the IKS will publish the outcomes of the test on the MRC website or in any publications and in conference presentations, in consultation with the claimant.

Step 5 - Disclosure of the information  
This meeting will be held for the claimant to disclose everything about the traditional medicine. IKS would like to know the following in as much detail as possible:  

  • The composition of the traditional medicine
  • How it is prepared in every detail
  • How much (in grams) are the components mixed, parts used
  • Methods of preparation in every detail
  • How it is used (doses) and how much is taken per day and when the medicine is taken (before, after or with meals)
  • For how long medicine should be taken
  • Anything else that need to be noted when taking the medicine
  • When and where the components are obtained
  • Any other information that the claimant feels is important regarding the whole process of disclosure

Step 6 - Literature search
The IKS will, with this information on hand, do literature searches to determine what has already been done or known about the claim and the individual constituents. Based on the results of the literature search and all information available to us, the IKS may decide whether or not to continue with the research. If IKS decides to continue, the following processes will follow:

A second agreement, which is fully contractual, will be drafted and signed by both parties. This agreement is on roles and responsibilities of each party towards the project. A detailed protocol on the execution of the tests will be attached as part of the MoA. It should be noted that once IKS has started with the experiments, the recipe cannot be altered.  

Step 7 - Funding options for clinical trails

  • This first option is where the claimant provides all the funding for the tests. The MRC is contracted as a service provider. The intellectual property (IP) will rest with the claimant unless the MRC has made an intellectual contribution in the process of improving the product or any other vital changes.
  • The second option is where the MRC will source funding to do the work for the claimant. For this option, the MRC will require the claimant to furnish minimum evidence supporting the claim, as would be required by the IKS Lead Programme. The MRC, in this option, is the partner and the normal research partnership conditions will apply, including, but not limited to using the product in poverty alleviation projects and the MRC have the first right to produce, improve and commercialize the final product.

Looking for sources of funding takes time as everything will depend on who is keen to finance the project. In order for IKS to proceed with any of the options stated above, there must be convincing and strong anecdotal evidence about the traditional medicine. This will determine the type of agreements entered into on matters of benefit sharing and ownership of the final product.

Step 8 - Supply of material by the claimant
IKS, based on the disclosed information, will work out the correct human daily dose and formulate a tablet, capsule, solution or syrup to standardize for the studies.

IKS will need to be assured of constant good quality and enough material for the research to be supplied. For quality purposes IKS will need to know where the material will be collected to seek collection permits from the relevant authorities.

Please note that the claimant will not be paid by IKS for the material supplied, as the material will be used for research he/she has requested. It is only in exceptional cases where a once-off amount, not exceeding R2000.00 will be made available for the claimant to buy or collect the required materials for the studies.   

Step 9 - Development of protocols
IKS will develop the protocols for the study that will be sent for peer review and to the MRC’s Ethics Committee thereafter, for ethical review. No evaluation studies will be commenced prior to ethical approval.

Step 10 - Study

  1. Toxicology  - Safety
    • Duration: 3 months
    • Analysis and report writing: ± 2 months
    • Prerequisite: Protocol peer-reviewed
    • Ethics approval by MRC

This is a safety test of the traditional medicine in a non-human primate model. This study takes 5 months (3 months for safety study and 2 months to collate, analyse the results and produce a full report).

  1. Phase I  - Safety Study (on healthy human participants)  
    • Duration: 5 weeks 
    • Analysis and report writing: ± 2 months
    • Prerequisite: Copy of toxicology report
    • Ethics approval by MRC
    • Insurance (indemnity) to be taken out

    This is a safety study on healthy human volunteers. Before it can be conducted, a full report of the non-human primate toxicology study is required, which means that this study cannot start unless the toxicology study is completed. The purpose of this phase is to determine the general safety, the correct dosage and possible negative or undesirable effects of the traditional medicine. The protocol is taken for peer review and to the ethics committee for ethical approval, before start of the study.   

Safety studies are expensive because they involve human participants, so an indemnity insurance cover is mandatory. This would be done to protect the participants and the research team involved in the study, i.e. should anything happen, the MRC, researchers or the traditional healer may not be sued/blamed by the participants. The participants will be covered for a year during the study of clinical trials.

  1. Phase II - Efficacy study (Effectiveness)
    • Duration: 6 months  
    • Analysis and report writing: ± 2 months
    • Follow-up at months 9 and 12 after the last dose given during the study
    • Prerequisite: Copy of the Phase I report
    • Ethics approval by MRC and MCC
    • Insurance to be taken out

    The purpose of the phase II is to test the safety and effectiveness of the traditional medicine. Before this study is conducted, a copy of a full report of phase I (safety study) is required. In this phase the medicine is tested on a larger group of people. People who are suffering from the disease for which the medicine is being developed, are also given an opportunity to participate in the study, e.g. HIV-positive individuals. The effectiveness and possible undesirable effects are evaluated in greater depth during this phase. This whole study takes about a year: ± 6 months for the test and ± 2 months for analysis and report writing and participant follow-up at month 9 and 12. The duration of the study will depend on the disease being tested for and how long it took to recruit all the participants for the study.    

Step 11 - Meeting with investigators
During the testing, the claimant is part of the trialists, though their interference and influence would be discouraged. The claimant is, at this stage,told that this is a scientific evaluation and should be run strictly as per the approved protocol. Meeting with investigators involved in the study will be held for recommendations after the completion of the study.

Step 12 - Duration of clinical trials and costs
To develop a drug from plants can be very lengthy and extremely expensive. The IKS [Health] Lead Programme has developed protocols that are both ethical and of the highest acceptable scientific standard for developing drugs from total plant extracts. The claimant therefore is cautioned that this process may take up to 2 years to be completed and we request the claimant’s patience. The claimant again will be part of the team and will be informed of progress of the study timeously and the MRC-IKS would require her/his cooperation with the research team and understanding of how the team works.

Step 13 - Publications and presentations
The IKS will, at the end of each evaluation phase, make presentations and publish the outcomes of the study in consultation with the claimant. Precautions will be taken not to jeopardize any obvious potential Intellectual Property (IP) that may result from the study.  All findings that cannot be protected for commercial exploitation shall be published and presented at conferences. In all our publications and presentations, the claimant’s contribution shall be acknowledged.
    
Step 14 - Registration with the Medicines Control Council (MCC)
Once the clinical trials are done, that means when it is already tested in several people to define its safety, effectiveness and long-term undesirable effects, it would be ready for registration, licencing and for commercialization. Registration and licensing should meet MCC requirements. The MCC should be contacted to obtain these guidelines. 

Activities of IKS (Health) in AIDS Research
The Indigenous Knowledge Systems [Health] Lead Programme at the MRC has, as one of its main objectives, the refocusing of health research priorities in a manner that gives neglected areas greater prominence. These neglected areas of health research include traditional systems of health care. The IKS [Health] Lead Programme has as its mandate to research traditional systems of health care by educating the communities, the general public, scientists and biomedical personnel about traditional practices and traditional medicinal products. It achieves this by evaluating the health benefits of traditional remedies through sound and internationally accepted scientific methods and standards.

The IKS [Health] Lead Programme has a number of programmes, one of which is dedicated to the evaluation of claims of health benefits for persons living with HIV/AIDS. These remedies are put through scientific scrutiny for their safety and effectiveness.

Safety: The lead programme has developed protocols for toxicological evaluation of traditional medicines and nutritional supplements. The products are tested on non-human primate models over a period of 3 months. This standard protocol is a sub-chronic toxicology study assessing changes in toxicological markers of major biological systems and organs.

Clinical trial platforms: There are now protocols developed for Phase I and Phase II clinical trials. These products are evaluated for their safety and efficacy on volunteers in randomized, parallel group, multi-dose, tolerance and placebo- controlled dual centre studies. These protocols are peer-reviewed for their scientific and ethical validity.

In evaluating these claims made for traditional medicines and nutritional supplements, the IKS [Health] Lead Programme uses ethical and scientific, globally accepted methods while at the same time it aims to add value to those products that pass these tests without raising false hopes of a cure for HIV/AIDS.

Traditional Medicines Drug Discovery
The IKS [Health] Lead Programme, through collaborative research at universities, are involved in basic research in scientific research to discover lead compounds and establish possible mechanisms of action of the compounds isolated from medicinal plants. The current collaborative research is addressing the following disease conditions: tuberculosis, malaria, hypertension, diabetes, cancer, HIV and AIDS.

Intellectual property
The Indigenous Knowledge Systems Lead Programme of the MRC has been mandated to assist in the protection of the intellectual property of traditional people. The Lead Programme therefore is committed to equitable and fair sharing of benefits, on mutually agreed terms, with legitimate holders of the knowledge.

Benefit-sharing
The Lead Programme’s goal is to add value to traditional medicines and, in so doing, share any benefits that may be derived from the scientific research and development to eventual commercialization of such research results with all concerned.

Before the royalties are paid, a publication would be done in a government gazette to legitimize the ownership of information avoid exploitation as someone may steal the information from another person and claim it as his/hers.

Databases
The program is involved in creating a number of databases which, depending on the sensitivity and level of information, are in the public domain. The following databases are being created:

TRAMED  III
This Unit (SATMERG) - South African Traditional Medicines Research Group, formerly known as TRAMED. This unit has a huge database of traditional medicines and medicinal plants (TRAMED III) and this database has been developed from a database of medicinal plants donated by Noristan Pharmaceuticals. The database has been developed to contain traditional uses, pharmacology, chemistry, indications etc. As a separate part of this database there is a database of student research work that is compiled on the scientific research, pharmacology, research results and thesis.

Monographs
SATMERG is a joint research group with the School of Pharmacy of the University of the Western Cape (UWC). UWC has developed monographs, and is continuing to do so, on the medicinal plants researched by the IKS Lead Programme. The idea is to develop a South African Pharmacopoeia. The monographs are made available on our website on a tiered basis, depending on the value of the information contained in the monograph. The monographs are housed at the IKS [Health] at the MRC. If funding can be secured for this project, the IKS [Health] will develop monographs for near all 4000 species of plants used in traditional medicines over the next 5 years. The monographs are available on our website on a tiered access base. Currently UWC is funded by the IKS Lead Programme to do this work.

Medicinal Plants (Current usage with scientific studies - clinical, Toxicology and chemistry)
IKS [Health] has created an inventory of all IKS health research funded by the MRC with an expressed interest for tracking such research.

Through the Clinical trials platform, the IKS [Health] has developed methods and procedures for handling claims for cures. A database of all claims presented at the IKS [Health] Lead Programme is documented. The uniqueness of this database is that it is the current medications and traditional practices that are used. It is a database that shows clinical trial validation and eventual commercialization of the claims. What is documented are the names of the individuals, the place of origin, the complete claims - names of plants ( including planting these at the Delft site for authentication and monograph creation), how the plants are prepared, how they are used, how these dosages are scientifically standardized and formulated, the agreements signed and entered into, beneficiaries, agreements of royalty pay-outs, the research result outcomes - clinical (toxicology and effectiveness - both in animal and human studies), licensing out agreements and also those claims that were not considered for evaluation are documented and the reason for not investing in them are detailed in the database.

GIS Mapping of Traditional Health Practitioners (THP’s)  
The IKS [Health] Lead Programme is developing a GPS mapping of traditional health practitioners in the country. This project has started in KwaZulu-Natal. The project documents up to the point in the Globe the location of traditional healers, their specialties, their proximity to schools, clinics, hospitals and the population in their surrounds.

This is an ambitious project projected to last 3 years, to be updated annually. Funding is urgently and desperately needed to complete this work. Part of this work has been developed in KZN.
In addition to the above, there is a database of invalidated traditional uses of plants by traditional healers. This database is collected by IKS [Health] staff during their informal interactions with traditional healers and traditional communities.

IKS Laboratories and resource centre
The resource centre is developed as a centre for exchange of information and knowledge between traditional healers and the biomedical personnel. The centre is a hive of activity for a number of community and scientific projects. The resource centre has been developed for traditional healers to have access to the vast knowledge available through the Internet.

  • Provide enabling environment for healers and scientists to interact
  • Formal structure for healers to interact, develop policy and develop communication products
  • Provide healers access to scientific infrastructure (Information, Library, Internet access, database, medicinal plant cultivation, drug discovery)
  • Provide a forum for structured health education and promotion (herb garden)
  • Develop skills in growing, processing, packaging and marketing of herbal products

Medicinal Plant Garden

The medicinal garden is used as an educational garden to school children, botanical identification of plants and communities and also as a starting stock for plantlets to be grown in the farm.

The medicinal garden is an educational program for communities, pupils, students and scientists.

Traditional Health Practitioners (THP’s) Training Program
A number of training programmes are being undertaken at the site. These projects have been designed together with THP’s and were identified as a need by traditional healers themselves.
The Awareness Training Projects include:

  • TB DOT Supporters 
  • HIV and AIDS
  • Introduction to HIV and AIDS Vaccines
  • Diabetes  
  • Record keeping
  • Training traditional healers, communities in the basic principles of herbal drug manufacturing
  • Infection Control
  • Collaboration and Referral System
  • Basic Counselling in a Traditional Workplace 
  • Traditional Healing Systems

Library
The library is for a free membership to Traditional Health Practitioners and communities. This library is part of the MRC’s main library but this is specific to traditional medicines and most book and articles are on traditional and complementary medicines. There are also elementary books aimed at educating traditional healers.

Computer library
The computer library is a resource for communities and Traditional Health Practitioners to access our websites and obtain updates on our research and will also provide access to the vast knowledge available on The Internet.

The Schools’ outreach program
The lead programme is committed to educating our communities and bring science back to the villages. We at IKS believe strongly in developing our foundation of science and traditional knowledge at the foundation phases. The Lead Programme’s outreach programme aims at educating pupils about their traditional knowledge and to value such knowledge.

Poverty alleviation projects

The lead programme runs a national programme on the commercial cultivation of scientifically validated medicinal plants, with potential markets to eradicate poverty through the creation of sustainable jobs in rural communities. These projects are in partnership with the private manufacturing sector. The project is a joint project of DST and the DOH. The individual partners can be contacted through their website links. The project is a true private Community Public Partnership (PCPP).

The aims of the project is to promote the application of scientific research into the practical implementation of projects oriented to create permanent sources of income, promote the development of sustainable enterprises and its integration into the value adding process of industrial development and commercialization of products.

IKS Utilization

Bringing Research Products to Policy, People and Market

  • For socio-economic development
  • Industrialization
  • Serious business development partnerships
  • Job creation & poverty alleviation
  • Sustainability
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Last updated:
8 October, 2013
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