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Completed

NCT Number: NCT05690217

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD participants were eligible if they 1) satisfied the diagnostic criteria of COPD; 2) 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 4) 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.

Treatment and study plan

Primary outcomes

  1. Perfusion unit

    Time frame: Baseline

    Perfusion unit of acupuncture points is measured by Laser doppler flowmetry

  2. Temperature

    Time frame: Baseline

    Temperature of acupuncture points is measured by infrared thermography

  3. Regional oxygen saturation

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

The Difference in the Biological Characteristic Characteristics of the Heart and Lung Meridians Between COPD Patients and Healthy Subjects

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2023
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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