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above baseline at week 2, 4 and 6, respectively. The amount of serum IL-6 was detected in

7, 6, 2 and 10 volunteers at week 2, 4, 6 and 8 respectively. The levels of IL-4 were
detectable in 1 and 2 volunteers at week 6 and 8, respectively. The frequency of the
nd
th
th
subjects with detectable IL-2 was significant in the 2 , 4 and 6 weeks of the study, while
nd
th
th
that of the subjects with detectable IL-6 was significant in the 2 , 4 and 8 weeks. There
was no significant difference in the frequency of the volunteers with detectable IL-4.
Discussion

We conducted the phase 1 trial to determine the safety of the hydroalcoholic
extract of D. scandens given to 12 normal volunteers at the dose of 400 mg/day for 2
months. There were no major side effects reported from any of the volunteers. The study

was, therefore, found to be well tolerated.
Laboratory investigations on hematological parameters and biochemical profiles
showed significant differences in Hct (%), basophil (%), the levels of hemoglobin, crea-

tinine, albumin, sodium and chloride. Increase or decrease in those values were within their
normal ranges of did not result in a clinically significant condition during the trial.
Cytokines are integral components that play a central role in the regulation of cell

differentiation, proliferation and intercellular communication network (6). They are re-
quired to mount and control immune responses. In this study, we measured the amount of
serum IL-2, IL-4 and IL-6 to assess the effects of the D. scandens extract on functions of

immune cells. IL-2 regulates proliferation and differentiation of lymphocytes (7). IL-4
promotes production of antibody (8,9,10). IL-6 is an inducer of plasma cell development
and has been shown to influence IL-4 production (11,12,13). Our findings may suggest
that the D. scandens extract could provide help in moderating secretion of Th1 and Th2

cytokines that are essential in activation and development of adaptive immune system.
Both the clinical and laboratory results demonstrated that the hydroalcoholic
extract of D. scandens did not induce any significant changes in all volunteers receiving the

extract at the dose of 400 mg/day (b.i.d.) for 2 months, suggesting that the extract is safe
for normals. In addition, the extract showed its capability to induce cytokines secretion. A
larger trial, however, should be performed to evaluate the effects of D. scandens on stimu-

lating immunity in normal volunteers as well as in immunocompromised persons such as
HIV-infected individuals.