The Potential Benefit of Xiao-Yao-San Treatment in Patients With Insomnia

Phase 4

Completed

• Conditions: Treatment
• Interventions: Drug: Xiao-Yao-San; Other: Weight loss class(WLC) group

• Registration Number: NCT06417515
• Lead Sponsor: Yu-Ching HSU

Brief Summary

The investigators recruited patients ages 20-65 from 2 groups in Tainan Hospital. One was from a weight loss class, also called WLC, one was from our regular clinic. These patients have no history of schizophrenia, narcolepsy, neurological disease, alcohol and drug addiction but had Pittsburgh Sleep Quality Index (PSQI) scores for psychometric properties ≥ 5 between January 1 to November 30 of 2019. The study group were the patients who received XYS for 28 days and the control group were those who didn't receive any Chinese medicine but attended the WLC. Age, gender, personal biodata, polysomnography findings, and these subjective sleep questionnaires were collected. The Wilcoxon test was used to compare the difference in pre and post evaluation in two groups. After comparing the objective and subjective assessment between the better and poorer performance in the XYS group, we would find more suitable criteria for XYS in traditional Chinese medicine.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2024-05-12
• Study First Posted: 2024-05-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• 20- to 65-year-old patients.
• Pittsburgh Sleep Quality Index (PSQI) scores ≥ 5.

Exclusion Criteria

• Schizophrenia.
• Narcolepsy.
• Neurological diseases (history of stroke, neurodegenerative diseases, etc.).
• Alcohol addiction.
• Drug addiction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xiao-Yao-San group	Xiao-Yao-San	Received Xiao-Yao-San for 28 days
weight loss class group	Weight loss class(WLC) group	The control group were those who didn't receive any Chinese medicine but attended the weight loss class.

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI) scores	Up to 12 weeks.	Sleep quality

Trial Locations

Locations (1)

Tainan Hospital, Ministry of Health and Welfare; 🇨🇳 Tainan, Taiwan