Table 5.
Safety parameters among ischemic stroke patients (phase III study).
| Aspirin + placebo | Aspirin + BJIKT | P | |||
|---|---|---|---|---|---|
| Baseline | Net change from baseline | Baseline | Net change from baseline | ||
| Liver function | |||||
| AST | 24.7 ± 4.9 | 1.8 ± 5.9 | 25.2 ± 5.4 | 2.0 ± 6.3 | NS |
| ALT | 23.5 ± 11.7 | 1.2 ± 8.6 | 21.4 ± 8.1 | 1.6 ± 6.2 | NS |
| GGT | 29.6 ± 12.5 | 0.0 ± 4.4 | 29.1 ± 16.2 | 0.1 ± 4.9 | NS |
| T-bil | 0.6 ± 0.2 | −0.0 ± 0.1 | 0.6 ± 0.2 | 0.0 ± 0.1 | NS |
| ALP | 78.1 ± 16.9 | 0.7 ± 7.4 | 68.5 ± 15.8 | 0.8 ± 6.2 | NS |
| Protein | 7.6 ± 0.5 | 0.0 ± 0.4 | 7.4 ± 0.4 | −0.0 ± 0.4 | NS |
| Albumin | 4.4 ± 0.1 | −0.0 ± 0.2 | 4.3 ± 0.2 | −0.0 ± 0.1 | NS |
| Kidney function | |||||
| BUN | 15.6 ± 2.5 | −1.8 ± 4.1 | 16.6 ± 5.3 | −2.3 ± 4.7 | NS |
| Cr | 0.7 ± 0.1 | −0.0 ± 0.0 | 0.8 ± 0.4 | −0.0 ± 0.0 | NS |
| Adverse effects | |||||
| Indigestion | 1 | 1 | NS | ||
| Diarrhea | 1 | 0 | NS | ||
BJIKT: Bojungikki-tang, AST: aspartate aminotransferase, ALT: alanine aminotransferase, GGT: gamma-glutamyl transferase, T-bil: total bilirubin, ALP: alkaline phosphatase, and BUN: blood urea nitrogen.