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薬理と治療
Abstract
Objective Andrographis paniculata(Burm.f.)Nees is used to treat a wide range of diseases traditionally. We have evaluated the safety in consecutive intake of 700 mg╱day of Andrographis paniculata(A. paniculata)extract for 12weeks, and showed no adverse clinical changes in the trial. This study aimed to verify the safety on excessive consumption of supplement containing A. paniculata extract in healthy subjects. Methods Non-randomized, open-label trial was conducted with 11 healthy Japanese subjects. All subjects were given test product for 4 wk. Daily intake of the test product was contained 3500 mg of A. paniculata extract. Safety was evaluated every 2 weeks by interview, physical examination, hematology and urinalysis. Results The elevation of liver functions(ALT, AST and╱or γ-GT)and╱or generalized rash were observed in 3 subjects. Two out of 3 subjects were withdrawn the study. The lymphocyte stimulation test associated with test product was positive in 1 subject withdrawn the study. These adverse events had resolved by the end of observation. One subject was also withdrawn the study by difficulty swallowing test product. Although 1 subject indicated stomachache due to dosage form of the test product, she completed the study. Conclusions It is possible that consecutive intake of 3500 mg╱day of A. paniculata extract for 4weeks causes allergic reaction or other physical symptoms.
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