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a phase I trial was conducted at the clinic of the Department of Medical Sciences using

healthy volunterrs to substantiate its safety in humans as well as its effects on immunologi-
cal parameters.

Materials and Methods

Selection of Subjects: Volunteers were informed that the D. scandens hydroalcoholic
extract was an herbal product. Summary of all laboratory results was explained to them in

simple non-technical language. The volunteers were encouraged to ask questions which
they need further clarification. They were informed that they could withdraw at anytime
during the trial while the clinical investigators could advise any volunteers to withdraw
from the trial if he/she developed adverse reactions to the D. scandens extract.

Eligible subjects were male or female individuals with ages ranging from 20 to
45 years, were negative to HB Ag, HCV and HIV-1/2, not taking medications affecting
s
their immune systems and without history of diabetes, cancer, allergy, heart, lung and

hematological disorders. Subjects who had liver or renal abnormalities detectable by his-
tory, physical examination or blood chemistry were not included in the study. Female
subjects who were pregnant or in lactation periods were excluded. No dietary supplements

were allowed during the study. Written informed consent was obtained from each of twelve
persons who met those criteria.
A study protocol was approved by the Ethical Review Committee of the Thai

Ministry of Public Health on December 4, 2000.

Treatment of the subjects
All 12 subjects were given capsules of D. scandens (b.i.d.) for 2 months. The

extract was prepared as previously described (4) and its quality was controlled by in vitro
determining immunostimulating activities. The extract was formulated into standardized
capsule dosage form. One capsule contained 200 mg of dry hydroalcoholic extract from D.

scandens stems.

Clinical assessment

At baseline and at biweekly visits, a physical examination was performed and a
review of adverse reactions, concurrent medication and compliance was completed. Ad-