Objective: To investigate the feasibility and preliminary effectiveness of Tanxiang Prescription (TXP) ointment for alleviating mild to moderate anxiety. Methods: A single-center pilot trial was conducted. Participants were randomly assigned to the experimental group or the control group. The experimental group received TXP treatment and health education, while the control group only received health education. The study evaluated the feasibility based on recruitment, retention, adherence, and adverse events. The primary outcome was assessed using the Self-Rating Anxiety Scale (SAS), while the secondary outcomes were evaluated using the Self-Rating Depression Scale (SDS) and Pittsburgh Sleep Quality Index (PSQI). Assessments were conducted at baseline, week 2, and week 4. Results: 58 participants were successfully enrolled, with 56 in all have finished whole research, which illustrating a recruitment rate of 33.7%, a randomization rate of 100%, and a loss rate of 3.57% in this study. No adverse events were observed. Both the experimental (n=29) and control (n=29) groups showed a significant decrease in SAS, SDS, and PSQI scores in comparison to their baseline scores at week 4 (P<0.05). Additionally, the experimental group showed significantly greater reductions in SAS, SDS, and PSQI scores than those in the control group at week 4 (P<0.05). Conclusions: TXP may be a promising treatment option for mild to moderate anxiety, offering a duel benefit of alleviating depression and promoting better sleep without any adverse effects. This study also references the effectiveness of Traditional Chinese Medicine aromatherapy for anxiety management. Further pharmacological and clinical studies are needed to observe the impact of TXP on emotional regulation in patients with anxiety.
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