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

Exploring Changes in Sleep Assessment of Patients With Sleep-related Diseases Treated by Chinese Medicine

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06417515

Enrollment

Registered

2024-05-16

Start date

2019-01-01

Completion date

2019-11-30

Last updated

2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment

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.

Interventions

DRUGXiao-Yao-San

Patients who received Xiao-Yao-San 9 g/day (Kaiser Pharmaceutical Co. Ltd.) were selected for the Xiao-Yao-San group by traditional Chinese doctor with 8 years of experience.

OTHERWeight loss class(WLC) group

Participants who attended the WLCs in our hospital and were willing to participate in our study were included in the WLC group (control group). Our WLCs consisted of 8 sessions of 2-hour dietary advice/exercise guidance and 1 session of weight-loss consultation in 3 months. The participants assessed their weights at the beginning, at 1.5 months, and after every class. They underwent pre-PSG tests in the beginning and post-PSG tests after 3 months of lectures.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pittsburgh Sleep Quality Index (PSQI) scores	Up to 12 weeks.	Sleep quality

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026