Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Depression
Insomnia
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT05764798
Study type	Interventional
Source	Nanfang Hospital of Southern Medical University
Contact	Bin Zhang, MD & PhD
Phone	86-20-62786731
Email	zhang73bin@hotmail.com
Status	Recruiting
Phase	Phase 1
Start date	November 30, 2022
Completion date	December 30, 2024

View Details

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