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TRAMIL quality, safety and effectiveness strategy

Survey results, specifically regarding the “health problem / plant-part used,” are compared with the existing bibliography and, if necessary, pharmacological, chemical and /or clinical tests (called TRIGs) are undertaken.  TRAMIL’s pool of specialists reviews the results of such tests and, taking into account the minimum quality and effectiveness standards, issues a specific recommendation.

In this project, EFFECTIVENESS means effect supported by:

  • Significant traditional use as established by the TRAMIL Surveys.
  • Results of published pre-clinical and/or clinical pharmacological research, or results of the research conducted by the TRAMIL group, called "TRIGS".

 

Our methodology requires demonstration of the effectiveness of the plant-part / administration-means combination in solving a health problem.  This requirement is a key differentiator of TRAMIL findings, compared to other ethnobotanical or ethnomedical studies that provide for the recording of plant knowledge without regard to therapeutic effectiveness.

 

MINIMUM QUALITY STANDARDS

Plant

  • Botanical identification of specimen (with voucher: gatherer /number / herbarium code).
  • Plant-part used, free of chemical or biological pollutants.

Preparation

  • Process standardization according to traditional preparation.

Application

  • Use of fresh (recently made) preparations, obtained with an aqueous solution (unless otherwise stated), non-preservable.
  • Use of hygienic conditions in preparation and administration.

 

MINIMUM EFFICIENCY AND SAFETY STANDARDS

  • Significant traditional use in TRAMIL Surveys.
  • Bibliographic evidence of pharmacological activity.
  • Pharmacological studies aimed at demonstrating reported activity*.
  • Toxicity studies proving compatibility with use (if they are not reported in the literature).

 

*The absence of positive results is NOT a criterion for disregarding its traditional use.  Only a controlled clinical assay on the specific vegetal drug can be considered definitive grounds for inefficiency.