The Difference in the Biological Characteristic Characteristics of the Heart and Lung Meridians

Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05690217
Collaborator
(none)
80
1
36
2.2

Study Details

Study Description

Brief Summary

The association between viscera and the body surface remains obscure, but a better understanding of it will maximize its diagnostic and therapeutic values in clinical practice. Therefore, this study aimed to investigate the specificity of the association between viscera and the body surface in the pathological state.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study subjects included 40 chronic obstructive pulmonary disease (COPD) participants in the COPD group and 40 age-matched healthy participants in the healthy control group. Laser doppler flowmetry, infrared thermography, and functional near-infrared spectroscopy were respectively adopted to measure (1) the perfusion unit (PU), (2) temperature, and (3) regional oxygen saturation (rSO2) of 4 specific somatic sites distributing in the heart and lung meridians. These 3 outcome measures reflected the microcirculatory, thermal and metabolic characteristics of the body surface, respectively.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Difference in the Biological Characteristic Characteristics of the Heart and Lung Meridians Between COPD Patients and Healthy Subjects
    Actual Study Start Date :
    Jan 1, 2019
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    COPD group

    There are 40 chronic obstructive pulmonary disease (COPD) patients in the COPD group.

    Healthy control group

    There are 40 age-matched healthy participants in the healthy control group.

    Outcome Measures

    Primary Outcome Measures

    1. Perfusion unit [Baseline]

      Perfusion unit of acupuncture points is measured by Laser doppler flowmetry

    2. Temperature [Baseline]

      Temperature of acupuncture points is measured by infrared thermography

    3. Regional oxygen saturation [Baseline]

      Regional oxygen saturation of acupuncture points is measured by functional near-infrared spectroscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • COPD participants were eligible if they 1) satisfied the diagnostic criteria of COPD;
    1. were in the stable phase of COPD; 3) were 20 ≤ age ≤ 75 years; 4) fully understood the study protocol and signed the written informed consent. Healthy participants were eligible if they 1) were healthy subjects who provided a medical examination report within 6 preceding months for confirming their health conditions; 2) were age-matched with the COPD group; 3) fully understood the study protocol and signed the written informed consent.
    Exclusion Criteria:
    • COPD patients were excluded if they 1) had other major lung diseases, such as bronchiectasis, pneumothorax, and lung tumors; 2) had concomitant heart diseases; 3) had serious concomitant diseases in major systems that were not controlled effectively
    1. had mental diseases, history of drug abuse, and alcohol dependence; 5) were lactating or pregnant and 6)had scarring, hyperpigmentation, redness, swelling and heat in the skin around the measurement sites, which would affect the accuracy of examinations. Healthy subjects were excluded if they 1) had mental illness, history of drug abuse and alcohol dependence; 2) were lactating or pregnant; 3) had scarring, hyperpigmentation, redness, swelling, and heat in the skin around the measurement sites, which would affect the accuracy of examinations.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the Third Affiliated Hospital of Zhejiang Chinese Medical University Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • The Third Affiliated hospital of Zhejiang Chinese Medical University

    Investigators

    • Principal Investigator: Jianqiao Fang, Ph.D, The Third Affiliated hospital of Zhejiang Chinese Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hantong Hu, Attending doctor, The Third Affiliated hospital of Zhejiang Chinese Medical University
    ClinicalTrials.gov Identifier:
    NCT05690217
    Other Study ID Numbers:
    • ZSLL-KY-2019-001
    First Posted:
    Jan 19, 2023
    Last Update Posted:
    Jan 19, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hantong Hu, Attending doctor, The Third Affiliated hospital of Zhejiang Chinese Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 19, 2023