NCT06452953

Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder

Comparative Study on the Cognitive Function and Brain Imaging of Modified Suanzaoren Decoction and Eszopiclone in the Treatment of Primary Insomnia Patients With Yin Deficiency and Hyperactivity of Fire Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe the cognitive function and clinical efficacy of modified Suanzaoren decoction and eszopiclone in the treatment of chronic insomnia disorder patients, and to investigate the possible neural mechanisms using MRI techniques.

Detailed description

The subjects were enrolled and divided into two treatment groups using the randomized numeric table method. Each group received either modified Suanzaoren decoction or eszopiclone treatment for a period of 4 weeks. General demographic data were collected, and changes in sleep, mood, cognitive function, and rs-fMRI before and after treatment were observed. Assessment tools included the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Hamilton Anxiety Scale (HAMA), and Hamilton Depression Scale (HAMD) for subjective measures, as well as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and polysomnography (PSG) for objective evaluation.

Conditions

• Chronic Insomnia Disorder

Interventions

Type	Name	Description
DRUG	suanzaoren decoction	The Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver
DRUG	Eszopiclone 1 mg	Eszopiclone is used in the treatment of various types of insomnia.

Timeline

• Start date: 2020-09-10
• Primary completion: 2023-10-31
• Completion: 2024-03-01
• First posted: 2024-06-11
• Last updated: 2024-06-11

Locations

1 site across 1 country: China