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

NCT06417515 | Completed Phase 4 DMC

• 1 other identifier: B-ER-107-174
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI) scores

  Sleep quality

  Up to 12 weeks.

Study Arms (2)

Xiao-Yao-San group

EXPERIMENTAL

Received Xiao-Yao-San for 28 days

Drug: Xiao-Yao-San

weight loss class group

OTHER

The control group were those who didn't receive any Chinese medicine but attended the weight loss class.

Other: Weight loss class(WLC) group

Interventions

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.

Xiao-Yao-San group

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.

weight loss class group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yu-Ching HSU: lead

Study Sites (1)

Tainan Hospital, Ministry of Health and Welfare

Tainan, 708, Taiwan

Location

MeSH Terms

Interventions

xiaoyaosan; Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• YU-CHING HSU

  Tainan Hospital, Ministry of Health and Welfare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Tainan Hospital, Ministry of Health and Welfare

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: May 16, 2024
• Study Start: January 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)