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Completed

NCT Number: NCT06417515

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

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.

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Key information

Conditions

Treatment

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tainan Hospital, Ministry of Health and Welfare

Tainan, 708, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xiao-Yao-San

Drug

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.

Weight loss class(WLC) group

Other

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI) scores

    Time frame: Up to 12 weeks.

    Sleep quality

Sponsors and collaborators

Lead sponsor

Yu-Ching HSU

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 16, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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