Traditional Chinese Medicine Herbal Sachet for Insomnia in Older Adults

This randomized, parallel‐group, participant‐blinded, placebo‐controlled trial enrolled154 adults aged 60 years or older with insomnia. Participants were allocated in a 1:1ratio using a computer‐generated random‐number table and sequentially numbered, sealed,opaque envelopes.The active intervention was a 100‐gram Traditional Chinese Medicine herbal sachetcontaining 10 powdered herbal ingredients. The formula was derived from an earlierexpert‐consensus development study. The placebo sachet contained five ingredients notexpected to improve sleep and was designed to resemble the active sachet in size, weight,appearance, and texture.Participants placed the assigned sachet within 30 centimeters of the head from 7:00 p.m.until 8:00 a.m. each night for eight weeks. Sachets were replaced every two weeks andstored in sealed bags during the daytime. Both groups received the same routinesleep‐related education and support.Insomnia symptoms and sleep quality were assessed at baseline, week 4, and week 8 usingthe Athens Insomnia Scale and Pittsburgh Sleep Quality Index. Adverse reactions,including allergic reactions and respiratory discomfort, were monitored throughout theintervention. The completed study was registered retrospectively.