NCT05690217

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

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 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 10, 2023

Last Update Submit

January 10, 2023

Conditions

Keywords

acupuncturemeridiansbiological characteristic

Outcome Measures

Primary Outcomes (3)

  • Perfusion unit

    Perfusion unit of acupuncture points is measured by Laser doppler flowmetry

    Baseline

  • Temperature

    Temperature of acupuncture points is measured by infrared thermography

    Baseline

  • Regional oxygen saturation

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

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The diagnostic criteria of COPD were based on criteria proposed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) consensus published in 2017, in which persistent airflow obstruction is confirmed according to the pulmonary function test. Healthy participants were determined by a medical examination report within 6 preceding months for confirming their health conditions.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jianqiao Fang, Ph.D

    The Third Affiliated hospital of Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations