Page 45 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

a) For Phase I / II studies –

Herbal Substance:

• plant description: genus, species (cultivar where
appropriate); region(s) and country (ies) of origin; time of
harvest; parts to be harvested

• plant processing: drying, mechanical disruption, solvent
extraction (aqueous or organic solvents, others)
• analytical procedures

• specification

• storage conditions/shelf life.

Herbal Product:

• amount of active ingredient

• list of excipients

• type of product (tablet, capsule, etc.) and its method of
manufacture
• analysis of recognized active ingredient(s) via chemical or
biological parameters

• analysis of a considerable chemical constituent (analytical
marker compound)

• analysis via chemical fingerprint (analytical markers)
• analysis for lack of contamination by pesticides, herbicides,
heavy metals, synthetic drug adulterants, microbials, toxins,
etc.

• dissolution studies

• storage conditions and stability during the length of the trial

• specification against which a certificate of analysis can be
assessed before the clinical trial material is released.

b) For Phase III studies:
Performing generally the same procedures as for Phase I/II
trials, but more extensively and with more strict control of
error.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 41