International Journal of Clinical Research

Objective To analyze the clinical efficacy of the self-formulated "Huoxue Tongluo Decoction" administered via herbal bath combined with oral traditional Chinese medicine (TCM) in patients with insomnia. Methods In this clinical study, 60 insomnia patients who visited our hospital from January 2024 to June 2025 were investigated and treated. Patients were randomly assigned to groups using a coin toss. The control group comprised 30 patients who received conventional oral medication. The study group also included 30 patients who, in addition to receiving the same conventional oral medication as the control group, were treated with a combination of oral TCM and herbal bath using the self-formulated "Huoxue Tongluo Decoction." The primary objective of the study was to observe and compare the treatment efficacy, insomnia condition, sleep quality scores, and TCM syndrome scores between the two groups. Results Compared with the control group, the total effective rate of treatment in the study group was significantly higher (P<0.05). Before treatment, there were no significant differences in insomnia severity or sleep quality scores between the two groups (P>0.05). After treatment, both groups showed improvement in insomnia and a significant decrease in sleep quality scores (P<0.05). Before treatment, there were no significant differences in TCM syndrome scores between the groups (P>0.05); after treatment, the TCM syndrome scores of patients in the study group were significantly reduced (P<0.05). Conclusion In the clinical treatment of insomnia, the combined use of the self-formulated "Huoxue Tongluo Decoction" via herbal bath and oral TCM can enhance treatment efficacy, effectively improve insomnia symptoms and TCM syndromes, and significantly improve patients' sleep quality.

Insomnia; Traditional Chinese Medicine; Huoxue Tongluo Decoction; Herbal bath; Clinical efficacy; Sleep quality; TCM syndrome