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

NCT ID: NCT05690217

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD group

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

No interventions assigned to this group

Healthy control group

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hantong Hu

Attending doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianqiao Fang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Locations

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZSLL-KY-2019-001

Identifier Type: -

Identifier Source: org_study_id