NCT05854680

Brief Summary

The new biomedical technology including genomics and metabolomics will be applied to the subjects with TCC practice to investigate clinical symptoms and signs expression. The investigators will compare the related molecular pathways especially focusing on immune and inflammation between long term practice and beginner groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

April 19, 2023

Last Update Submit

May 2, 2023

Conditions

Keywords

Traditional Chinese medicineYin and YangTai Chi ChuanMetabolomics

Outcome Measures

Primary Outcomes (3)

  • Serum metabolites

    Collect blood and measure the level of serum metabolites .

    on the day of admission.

  • Plasma Cytokines

    Collect blood and measure the level of plasma cytokines. Comparison of cytokine values between different groups.

    on the day of admission.

  • Constitution in Chinese Medicine Questionnaire (CCMQ)

    completed on the day of admission.

Secondary Outcomes (4)

  • Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4)

    completed on the day of admission.

  • 36-Item Short Form Health Survey (SF-36)

    completed on the day of admission.

  • Pittsburgh Sleep Quality Index (PSQI)

    completed on the day of admission.

  • BDI-II score

    completed on the day of admission.

Study Arms (2)

Long term

Tai Chi has been practiced for at least five years, regular practice, at least three times a week, each practice for at least 30 minutes.

Short term

Tai Chi practice time is less than three months, regular practice, at least three times a week, each practice for at least 30 minutes.

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The enrolled normal subjects were confirmed by the Tai Chi Association and the research PI. The long-term group has practiced Tai Chi for at least five years, and the short-term group has been practiced for less than three months. Men and women aged between 20 and 65 are included. We collected all of subjects' basic information, four diagnosis associated with TCM Syndrome Differentiation, FACIT-Fatigue scale, PSQI, BDI-II, SF-36 questionnaire scale, blood tests for CBC, liver and kidney function as well as metabolite analysis.

You may qualify if:

  • Adult men and women aged over 20 and under 65.
  • Participants agreed to join the trial by fully understanding the purpose of the study and the entire trial process and then signed an informed consent.

You may not qualify if:

  • Age of subjects was under 20 or more than 65 years old.
  • Subjects were using immunosuppressive or chemotherapy drugs.
  • With a history of drug abuse.
  • Pregnant or breastfeeding women.
  • Mental or behavioral abnormalities such as schizophrenia, depression, suicidal ideation, etc.
  • Suffering from serious diseases such as myocardial infarction, heart failure, arrhythmia, chronic respiratory obstructive diseases, cancers, gastrointestinal bleeding (OB positive), etc.
  • Subjects with abnormal blood count, abnormal liver function (\>2 times the normal value), and abnormal renal function.
  • Subjects were still participating in other clinical trials.
  • Subjects were not willing sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, North District, 404, Taiwan

Location

Study Officials

  • Sheng-Teng Huang, MD PhD

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 11, 2023

Study Start

January 8, 2020

Primary Completion

July 2, 2021

Study Completion

December 10, 2021

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations