Page 46 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

Herbal Substance:

• as above for Phase I/II trials.

In addition:
• statement that the plant is cultivated according to Good
Agricultural Practices or harvested according to Good
Wild crafting Practices
• reference batch.

Herbal Product:
• as above for Phase I/II trials

In addition:
• environmental impact statement.

This relevant information should be included in the protocol for
evaluation of these products, because of the extensive use of
traditional AU formulations both in animals and humans, which
helps in analysis of the chemistry, manufacturing, and control of
the product. The manufacture of the product should ideally be as
per traditionally processed formulation to authorize the statement
for efficacy as seen in traditional practice.
It is claimed that the extracts of herbal products and AU
formulations provide a therapeutic advantage, as they are mixture
of at least partially uncharacterized constituents and these
unknown constituents may be additive or synergistic in action or
may produce a balance to counteract adverse effects of any one
constituent. This may thus provide more efficacy than would be
provided by the known constituent alone. Thus, purification of the
medicines down to known or otherwise single chemical constituents
is not required as it may lead to loss of the advantage provided by
the mixture.

Analysis of the active pharmaceutical ingredient(s) may be best
approached by analysis of one or more active biomarker(s), analysis
of a chemical constituent that constitutes a sizable percentage of
the total ingredients, and a chemical fingerprint of the total
ingredients for standardization and quality control. The latter two
analyses would act as replacements for analysis of the unknown
constituents that contribute to efficacy. In order to have the best
standards by minimizing variation of content from batch to batch
several analytical procedures may be needed to adequately quantify
the constituents of herbal products or AU formulations.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 42