elev8™ Development Information

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elev8™ tablets represent a new generation of scientifically and clinically researched and validated natural herbal medicine. Zembrin®, the active plant extract in your elev8™ tablets is one of the most thoroughly studied standardised medicinal plant extracts on the global market, developed by HG&H Pharmaceuticals (Pty) Ltd with an international Research & Development team of scientists and clinicians, according to global best practice. It has taken more than a decade of concerted scientific and clinical research to produce this product.

 

1. Achievements include:

Zembrin® has been thoroughly studied for safety in three clinical trials and in laboratory studies, and has been granted GRAS (Generally Recognised As Safe) status in the USA. Zembrin® has been studied for efficacy in three clinical trials. The quality of Zembrin® is assured through the cultivation of a select variety of Sceletium using our own seeds, and the standardised extract manufactured at a certified EU (European Union) -Good Manufacturing Practice facility. Read more

 

The Zembrin® R&D team were the first to identify, patent and publish the chemistry & pharmacological mechanisms of action in Zembrin®. (Patents: US#6,288,104, new patent applications : PCT/IB2010/051132 and PCT/IB2010/051132; Harvey et al. 2011. Pharmacological actions of the South African medicinal and functional food plant Sceletium tortuosum and its principal alkaloids. Journal of Ethnopharmacology). Zembrin® is the first Sceletium product to have been clinically studied, with published clinical study results (Nell et al. 2013. A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of Extract Sceletium tortuosum (Zembrin®) in Healthy Adults. Journal of Alternative and Complementary Medicine).

 

2. Environmental:

No wild stocks of plant are used. Zembrin® is extracted from a unique naturally-occurring variety of Sceletium tortuosum that has been successfully developed as a new commercial crop for the first time.

 

The developers of Zembrin®, HG&H Pharmaceuticals (Pty) Ltd., have been ceremonially awarded the first Bioprospecting and Export Permit that has ever been issued in South Africa (Permit number IEP0001) (Integrated Export and Bioprospecting Permit).

 

In March 2013, Zembrin® was recognised as the ‘most sustainable ingredient’ at the prestigious annual Natural Products Expo West held in Anaheim, USA. Zembrin® was noted as one of the leading ingredients pioneering the next great foundation of new product development.

 

3. Indigenous rights:

Concluding the first African ‘prior informed consent’ benefit sharing agreement with the South African San Council as beneficiaries, demonstrated by the logo of the South African San Council on the package.

Traditional African Medicine: This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.