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verse reactions were all disorders of well being, subjective and objective symptoms, sig-

nificant laboratory changes, concomitant illnesses occurring during the course of the study.

Laboratory assessment
Blood was taken from each volunteer on the first day and at the ends of weeks 2,

4, 6 and 8 of the trial for complete blood count (CBC), Red blood cell (RBC) and platelet
counts, for biochemical and immunological assessment.

Hematological analysis was performed using an automatic hematological analyser
(Cell dyne 3500, Abbott). Hematological parameters measured were white blood cell (WBC),
% neutrophil, % lymphocyte, % monocyte, % eosinophil, % basophil, red blood cell (RBC),
hemoglobin, hematocrit (Hct), and platelet.

Biochemical analysis of serum samples was performed using an automatic chem-
istry analyser (Hitachi model 912, Roche). Biochemical parameters measured were aspar-
tate aminotransferase (AST), alanine aminotrasferase (ALT), alkaline phosphatase (ALP),

bilirubin, creatinine, blood urea nitrogen (BUN), cholesterol, triglycerides, total protein,
albumin, uric acid, glucose, sodium, potassium and chloride.
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Immunological assessment was quantitated for CD3 , CD4 and CD8 cells by a
flow cytometer (EPICS-XL, Becton Dickinson, USA). The amounts of serum IL-2, IL-4
and IL-6 were examined using Human IL-2 ELISA, Human IL-4 ELISA and Human IL-
6 ELISA kits, respectively (ENDOGEN, Inc., USA).

Statistical analysis
Data were analyzed by an SPSS program version 9.0. Statistical comparisons of
means of laboratory measurements were performed using repeated measured ANOVA. The

numbers of subjects with increasing amounts of each cytokine were analyzed by Fisherûs
Exact test.

Results
The study was designed to primarily determine the safety of the D. scandens
hydroalcoholic extract in normal volunteers. Additionally, preliminary assessment of its

efficacy on immunity was examined. Twelve volunteers, consisting of 6 males and 6
females, were recruited in this trial. Safety assessment was performed at the baseline and
every 2 week of the trial period. Each person served as his own control.