PRESENTATION #4 OUTPUTS 1.1 AND 2.4: AFRICAN GINGER: CLINICAL TRIALS - - PowerPoint PPT Presentation

PRESENTATION #4

OUTPUTS 1.1 AND 2.4: AFRICAN GINGER: CLINICAL TRIALS & SUPPORT TO CULTIVATION

GEF Full-Sized Project (FSP): Development of value chains for products derived from genetic resources OUTPUT 1.1: Undertake clinical studies and registration of Siphonochilus aethiopicus (African Ginger) to treat inflammatory and allergic diseases

GEF PROJECT PREPARATION GRANT (PPG) PHASE STAKEHOLDER WORKSHOP, PRETORIA, 26 APRIL 2016

African Ginger (Siphonochilus aethiopicus)

• Widely used in traditional medicine throughout SA.
• Organic extracts (specifically the ethanol extract) and

an active furanoterpenoid from the rhizomes of the plant have been developed for the management of allergic/inflammatory diseases, infectious respiratory diseases and mild asthma.

• The distribution of this plant species is restricted to

Mpumalanga, Northern Province and Kwa-Zulu Natal.

• Overharvesting has led to concerns about regional

extinction.

Opportunity Statement

• Allergies are a major health-care problem worldwide with about 30-40% of the world’s

population effected by one or more allergic condition/s.

• WHO has estimated that 400 million people suffer from allergic rhinitis in 2011 (WAO,

2011).

• Complementary medicines (CAMs) such as traditional Chinese medicine (TCM) and

Ayurveda have become increasingly popular for the treatment of allergic conditions.

• In SA, sales of allergy (hay fever) remedies in 2011 reached R 2.5 billion.
• Collectively, pre-clinical results of S. aethiopicus demonstrated the beneficial

properties of the plant extract in the improvement of the symptomatology associated with allergic and infectious diseases.

• However there is currently no clinical evidence of its safety and efficacy.

Output 1.1: Strategic focus for GEF support

The strategic focus of the proposed project is to add value to the African ginger value chain, through technology development (clinical studies) and to strengthen ABS agreements Activities for support:

• 1. Amendment of the CSIR-Traditional Healers Committee benefit sharing

agreement

• 2. Clinical studies (clinical trials, adsorption/metabolism studies and observation

studies) – To determine safety

• 3. Registration as a complementary medicine

Output 1.1 - GEF indicative budget

Activity Description Budget

1

Amendment of the existing CSIR-THC Benefit Sharing Agreement $93 000

2

Clinical studies $471 000

3

Registration as a complementary medicine $54 000

TOTAL

$618 000

Output 1.1: Implementation arrangements

• Local implementation of Output = Council for Scientific and

Industrial Research (CSIR)

OUTPUT: 2.4 Cultivation of Siphonochilus aethiopicus (African Ginger)

Problem statement

• Overharvesting has led to the species listed as Critically Endangered on the

South African Red Data List (Lotter et al. 2006).

• Demand for the plant material is growing, large requirements for clinical

trials (approximately two tons)

• Currently, three propagation sites have commercial potential:
• Kwa-Zulu Natal
• Mpumalanga
• North West
• However, sites require assistance in the form of agricultural support, to meet

requirements.

Output 2.4: Activities for GEF support

1. Identification of suitable sites for cultivation.

• Conduct on site research to understand the economic viability and sustainability
• f the crop.

2. Development (training, infrastructure, equipment, technical support, HR costs, marketing) of community-based agri-processing business/es to cultivate and harvest fresh rhizomes

• Assist the selected site(s) with the technical support in developing a community

based agri-processing business to cultivate, harvest fresh rhizomes and on farm pre-processing (washing, slicing and drying).

Output 2.4 - GEF indicative budget

Activity Description Budget

1 Identification of suitable sites for cultivation

$20 000

2 Development (training, infrastructure, equipment, technical support, HR costs, marketing) of community-based agri- processing business/es to cultivate and harvest fresh rhizomes as well as pre-process at farm-gate level

$430 000

TOTAL

$450 00 000

Output 2.4: Implementation arrangements

• Local implementation of Output = Agricultural Research

Council (ARC)

END