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

Y

Yu-Ching HSU

Status and phase

Completed
Phase 4

Conditions

Treatment

Treatments

Drug: Xiao-Yao-San
Other: Weight loss class(WLC) group

Study type

Interventional

Funder types

Other

Identifiers

NCT06417515
B-ER-107-174

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

20+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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