Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452953
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Brief Title:
Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder
Sponsor:
Central South University
Organization:
Central South University
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None