The Effect of Zao Ren An Shen Capsule on Insomnia among Patients with Anxiety: A Randomized Controlled Trial

Background. Zao Ren An Shen capsule (ZRASC) is one of the most widely used Chinese herbal medicine (CHM) in treating insomnia, but its effect on insomnia patients with anxiety remains unclear. We aimed to examine ZRASC combined alprazolam compared those only prescription. Methods. conducted a single-blind, parallel-group, randomized trial involving persons from 2 hospitals China. Participants were randomly assigned 1 : ratio intervention group, which participants provided and alprazolam, or control alprazolam. The primary outcomes symptoms measured by severity index (ISI). secondary Hamilton rating scale (HAMA). All followed up at 2-week 4-week after treatment. was estimated using mixed-effect models. Results. A total 334 enrolled trial. 167 them (mean (SD) age, 44.4 (12.8) years; 43.1% female) usual treatment while 46.0 (13.4) 43.7% group. From baseline 4-weekfollow-up, mean differences ISI HAMA scores between group care −2.542 −2.563, respectively (both p < 0.001 ). Patients more likely have remission than incidence rate ratios 265% 213%, id="M2"> Proportions 74.93% ( id="M3"> ) for 85.80% id="M4"> 4-weekfollow-up. Conclusions. This study showed that adjunctive able reduce Trial Registration. registered Clinical Registry (ChiCTR1800019913).