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Adverse effects

There was no anaphylactic reaction reported from any volunteers. All of them
nd
were compliant with the study for the whole 2 months. At the 2 week of the trial, one
volunteer had a headache, one had lots of sweat and the other one had constipation. Three
subjects reported sleepiness at week 2. Increasing in food consumption was observed in 3

persons (one was at week 2, another one was at week 4 and the other one was at week 8
of the study.) No other signs of side effects were noticed during the duration of the trial.

Laboratory results

Effect on hematological parameters
Significant changes in the number of white blood cell, neutrophil (%), lympho-

cyte (%), monocyte (%), eosinophil (%), the number of red blood cell and platelet were
not observed during the trial. The level of hemoglobin and the percentage of hematocrit
were significantly decreased at week 4 and 6 and at week 6 and 8, respectively, as com-

pared with the baseline (week 0) measurements (Table 1). Significant increase in basophil
(%) was found at week 2, 4, 6 and 8.

Effect on blood chemistry
To assess effects of the extract on metabolism, liver and renal functions, the
levels of the biochemical profiles at baseline were compared with those at biweekly visits.

There was no significant alteration in the levels of liver enzymes (AST, ALT and ALP),
bilirubin, BUN, cholesterol, triglycerides, total protein, uric acid, glucose, and potassium
(Table 2). The levels of creatinine were significantly increased at week 2 and 6. The levels
of serum albumin at week 2, 4 and 6 were significantly decreased. Sodium levels at week

2 and 4 were significantly lower than the baseline level but those at week 6 and 8 were
significantly elevated. Serum chloride levels were significantly decreased at week 2 and 4.

Effect on immunological parameters
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There were no significant changes in the numbers and the percentages of CD3 ,
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+
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CD4 and CD8 cells and the ratios of CD4 to CD8 cells during the trial (Table 3). No
detectable levels of serum IL-2, IL-4 and IL-6 in all 12 volunteers were found at the onset
of the study (Table 4). The levels of serum IL-2 were detected in 5, 4, and 4 subjects