NCT05764798

Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms: A Randomized Double Blind Controlled Study

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Experimental group: Shugan Jieyu Capsule combined with zolpidem	Shugan Jieyu capsule and zolpidem orally for 8 consecutive weeks
DRUG	Control group: Placebo combined with zolpidem	Placebo and zolpidem orally for 8 consecutive weeks

Timeline

• Start date: 2022-11-30
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-03-13
• Last updated: 2023-03-13

Locations

1 site across 1 country: China