The Homeopathic Proving is structured to establish foundations for determining various indications of use in animals and humans.

The Investigation will analyze “symptoms and syndromes” targeting specific parameters, more traditional, double blind control studies for future official inclusion of the preparation in the Homeopathic Pharmacopeia of the United States.

Some of the first applications of medical statistics began with homeopathic “proving”. Derived from the German word meaning “test”, a “proving” is a method used to determine which homeopathic remedies are suitable for specific “indications of use”. A “proving” is important to development of clinical trials due to the early use of simple control groups that help establish systematic and quantitative procedures aimed at determining the “indications of use”.

The Homeopathic Proving is being conducted in select clinics across America, and will be carefully monitored for compliance with each aspect of this immune-support approach. The Homeopathic Proving for the specific indications of use will investigate dosage amounts, route and the frequency of administration necessary to produce symptoms of healthy immune response for various syndromes.

To support the Homeopathic Proving, private industry interests in early 2008 collaborated with the scientists in the homeopathic preparation of the synthesized, Vitalethine derivative activated and potentized for human and animal use. The preparation was manufactured for distribution by Meditrend, Inc. under the trade name VitaleGENx upon submittal of form 2657 Drug Product Listing to the Food and Drug Administration under NDC number 062713 200. The preparation manufactured in accordance with the Homeopathic Pharmacopeia of the United States is dispensed to participants in compliance with federal and state regulations that govern compounding pharmacies accommodating individualized prescriptions by medical professionals licensed to administer homeopathic injectables.

In accordance with the tenets of homeopathy, a “proving” in clinical settings will determine “indications of use” for the homeopathically prepared, activated and potentized Vitalethine-derived compound. Individualized homeopathic dilutions, prepared by selected compounding pharmacies, are available by prescription only from licensed medical practitioners to those participating in the Homeopathic Proving.

Outcomes of the indications of use will provide the “proving” data to determine the symptom response framework for structuring more formal controlled clinical studies necessary for official inclusion in the partial list of homeopathic remedies in the Homeopathic Pharmacopeia of the United States.