Study on the safety of Polygala tenuifolia Willdenow root extract powder (BT-11) in young person aged from 9 to 19 years old

Ethnopharmacological relevance: Polygala tenuifolia Willdenow root extract (BT-11) has beneficial effects on central nervous system disorders in human. The safety of BT-11 should be elucidated in younger person further.

Aim of the study: To evaluate the safety of BT-11 in human aged from 9 to 19 years old.

Material and methods: The safety was evaluated in randomly assigned subjects who received the test products (61 subjects in BT-11 300 mg daily or 60 subjects in matching placebo) for 12 weeks. Adverse reactions were analyzed by the incidence rate, type, and severity. The clinical examination included hematology and blood chemistry tests, urinalysis, vital signs, body weight, and electrocardiogram (ECG).

Results: Eleven adverse reactions were observed in ten subjects receiving BT-11 while seven adverse reactions in six subjects receiving placebo. There were no statistical differences in the incidence of adverse reactions between the two groups. Serious adverse reactions such as acute appendicitis and acute viral gastroenteritis were observed in the BT-11 group4 and the placebo group, respectively. However, it was confirmed that they were not associated with the test product. All other adverse reactions observed during the test period were resolved completely without special treatment. No statistical difference was also observed in safety laboratory tests, vital signs, and ECG between two groups.

Conclusions: This study demonstrates the safety of BT-11 in the adolescent by showing no apparent adverse reactions related to it.