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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chinese Medicine in Treating Insomnia

NCT06511011

Insomnia Chronic

NOT_YET_RECRUITING PHASE2

Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder

NCT06452953

Chronic Insomnia Disorder

COMPLETED NA

Effectiveness and Safety of Shaoyao Gancao Decoction With Addition on the Sleep-related Leg Cramps

NCT05980637

Sleep-related Leg Cramps

UNKNOWN PHASE2/PHASE3

The Correlation Study of Hypnotic Drugs on the Cognitive Function of Patients With Chronic Insomnia.

NCT04996953

Insomnia Chronic

UNKNOWN

Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal

NCT06244277

Traditional Chinese Medicine Sleep Disorder

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Xiao-Yao-San group

Received Xiao-Yao-San for 28 days

Group Type EXPERIMENTAL

Xiao-Yao-San

Intervention Type 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 group

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

Group Type OTHER

Weight loss class(WLC) group

Intervention Type 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.