Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

Summary

This study is a randomized, placebo-controlled, double-blind clinical study. 60 cases of insomnia patients with depressive symptoms are planned to be treated, and they are randomly assigned to the experimental group (Shugan Jieyu Capsule combined with zolpidem group) and the control group (placebo combined with zolpidem group) in equal proportion. Both groups are given zolpidem orally for basic treatment, with the treatment dose of 10mg per tablet per day, one tablet per time, once a day, before sleep, for 8 consecutive weeks. The test group was given Shugan Jieyu Capsule orally, with a therapeutic dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The control group was given placebo orally, with a treatment dose of 0.36g per capsule, 2 capsules each time, twice a day, and once after breakfast and dinner. The therapeutic effect of Shugan Jieyu Capsule on insomnia patients with depressive symptoms was observed by analyzing the changes of ISI scores, subjective and objective sleep indicators (PSG, sleep diary), daytime cognitive function, autonomic nervous function and EEG after the intervention in the fourth and eighth weeks.

Timeline

Start

2022-11-30

Primary completion

2024-12-30

Completion

2024-12-30

Publications

• Xin Q, Paudel D, Zhang J, Wei H, Huang H, Lv Z, He W, Xu Y, Zhang B. Neural mechanism of Shugan Jieyu combined with zolpidem in insomnia disorder with depressive symptoms: evidence from event-related potentials in Go/No-Go and psychomotor vigilance task. BMC Psychiatry. 2026 Mar 28;26(1):408. doi: 10.1186/s12888-026-08023-y.
• Xin Q, Paudel D, Zhang J, Wei H, Cheng Y, Xu Y, Fang R, Jiang J, Wang Y, Zhang B. Efficacy and safety of Shugan Jieyu capsules in combination with zolpidem for insomnia disorder with depressive symptoms: a double-blind randomized controlled trial. BMC Complement Med Ther. 2025 Oct 17;25(1):383. doi: 10.1186/s12906-025-05142-z.

Drugs

Indications