## Protocol Section
### Identification Module
**NCT ID:** NCT06417515

**Brief Title:** The Potential Benefit of Xiao-Yao-San Treatment in Patients With Insomnia

**Official Title:** Exploring Changes in Sleep Assessment of Patients With Sleep-related Diseases Treated by Chinese Medicine

#### Organization Study ID Info
**ID:** B-ER-107-174
#### Organization
**Class:** OTHER
**Full Name:** Tainan Hospital, Ministry of Health and Welfare
### Status Module
#### Completion Date
**Date:** 2019-11-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-11-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-08
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yu-Ching HSU

#### Responsible Party

**Investigator Affiliation:** Tainan Hospital, Ministry of Health and Welfare

**Investigator Full Name:** Yu-Ching HSU

**Investigator Title:** Tainan Hospital, Ministry of Health and Welfare

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** We 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 Module

**Conditions:**

- Insomnia, Chinese Herbs, Xiao-Yao-San, Polysomnography

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 19

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Received Xiao-Yao-San for 28 days

**Intervention Names:**

- Drug: Xiao Yao San

**Label:** Xiao-Yao-San group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Weight loss class(WLC) group

**Label:** weight loss class group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Xiao-Yao-San group

**Description:** Patients who received XYS 9 g/day (Kaiser Pharmaceutical Co. Ltd.) were selected for the XYS group by traditional Chinese doctor with 8 years of experience.

**Name:** Xiao Yao San

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- weight loss class group

**Description:** 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.

**Name:** Weight loss class(WLC) group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Sleep quality

**Measure:** Pittsburgh Sleep Quality Index (PSQI) scores

**Time Frame:** Up to 12 weeks.

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tainan

**Country:** Taiwan

**Facility:** Tainan Hospital, Ministry of Health and Welfare

**Zip:** 708

#### Overall Officials

**Official 1:**

**Affiliation:** Tainan Hospital, Ministry of Health and Welfare

**Name:** YU-CHING HSU

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10356

- Name: Sleep Initiation and Maintenance Disorders

- Relevance: HIGH

- As Found: Insomnia

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007319

- Term: Sleep Initiation and Maintenance Disorders

### Misc Info Module

- Version Holder: 2024-05-31
