Effect of Traditional East Asian Medicinal herbal tea (HT002) on insomnia: a randomized controlled pilot study

Abstract Background Complementary and alternative medicine treatment for insomnia has been sought due to the possible adverse effects of conventional pharmacotherapies. We performed a preliminary evaluation of the feasibility of using, and of the effect of a herbal tea (HT002), based on Traditional East Asian Medicine, in mild-to-moderate insomnia. Methods Patients ( n  = 40) with mild-to-moderate insomnia were randomized to the HT002 ( n  = 20) or waitlist ( n  = 20) groups. The HT002 group consumed HT002 twice daily for 4 weeks. Outcomes were assessed using the Insomnia Severity Scale (ISI), Pittsburgh Sleep Quality Index (PSQI), and 12-item Short Form Health Survey (SF-12) at baseline and after 4 and 8 weeks. Results The ISI score differences from baseline at weeks 4 and 8 were significantly greater in the HT002 than that in the waitlist group (week 4: −4.0 ± 0.8 vs. −0.4 ± 0.8, p p p p Conclusion Our preliminary results suggest that a 4-week treatment with HT002 may reduce the severity of insomnia symptoms and improve the quality of life. Further studies devoid of the limitations of our protocol may provide stronger conclusions. Trial registration Clinical Research Information Service (CRIS), KCT0001900.