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The Difference in Heat Transport Characteristics of the Heart and Lung Meridians

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Infrared thermography

Moxibustion

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, infrared thermography

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for COPD

Patients should meet the above diagnostic criteria, and the severity of COPD is in the stage of GOLD 2 or 3 based on pulmonary function testing;
COPD patients in the stable phase, who present with mild symptoms of cough, expectoration and short breath;
35 ≤ age ≤75 years, male or female;
Patients have clear consciousness and could communicate with others normally;
Patients could understand the full study protocol and have high adherence.Written informed consent is signed by themselves or their lineal kin.

Inclusion criteria for health volunteers

Healthy volunteers who could provide a recent medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
35 ≤ age ≤75 years, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin.

Exclusion Criteria:

Exclusion criteria for COPD

Patients who fail to meet the diagnostic criteria for COPD, or COPD patients in the phase of acute exacerbation;
Patients have the following complications, which includes pneumonia, bronchial asthma, bronchiectasis, active tuberculosis, pneumothorax, chest trauma, tumors of the lung or thorax, and other confirmed respiratory diseases;
Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris (CSAP);
Patients have serious concomitant conditions and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological, and nervous system;
Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;
Pregnant or lactating patients; Patients are participating in other trials.

Exclusion criteria of health volunteers

Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
Pregnant or lactating participants ;
Participants are participating in other trials.

Sites / Locations

the Third affiliated hospital of Zhejiang Chinese Medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Arm Label

COPD group

Healthy control group

Healthy intervention group

Arm Description

This group will include 40 patients with chronic obstructive pulmonary disease (COPD).

This group will include 40 healthy volunteers.

This study will include 40 healthy adults. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively.

Outcomes

Primary Outcome Measures

Temperature change of relevant sites

Infrared thermal imaging is used to record baseline temperature and the temperature change of corresponding sites along the Heart and Lung meridians.

Secondary Outcome Measures

Full Information

NCT ID

NCT04046588

First Posted

August 2, 2019

Last Updated

March 4, 2020

Sponsor

Zhejiang Chinese Medical University

Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04046588

Brief Title

The Difference in Heat Transport Characteristics of the Heart and Lung Meridians

Official Title

The Difference in Heat Transport Characteristics of the Heart and Lung Meridians: a Comparative Study of COPD Patients and Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Chinese Medical University

Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes.Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study is designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermography. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.

Detailed Description

This study will include 40 patients with chronic obstructive pulmonary disease (COPD) and 80 healthy adults. Infrared thermal imaging(ITI) examination will be adopted to assess the heat transport characteristics of the Heart and Lung meridians and investigate the specificity for the meridian-visceral correlation and site-to-site correlation between two specific meridians.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, infrared thermography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD group

Arm Type

Other

Arm Description

This group will include 40 patients with chronic obstructive pulmonary disease (COPD).

Arm Title

Healthy control group

Arm Type

Other

Arm Description

This group will include 40 healthy volunteers.

Arm Title

Healthy intervention group

Arm Type

Experimental

Arm Description

This study will include 40 healthy adults. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively.

Intervention Type

Diagnostic Test

Intervention Name(s)

Infrared thermography

Intervention Description

A thermal imager (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) will be used to record thermal images. The temperature of corresponding sites on the Heart and Lung meridians will be analyzed.

Intervention Type

Procedure

Intervention Name(s)

Moxibustion

Other Intervention Name(s)

Infrared thermography

Intervention Description

Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian, respectivey. During moxibustion, the temperature change of relevant sites in the Heart and Lung meridians will be measured by infrared thermal imaging. Intervention in the Heart meridian: moxibustion will be performed above the acupoint HT3 of the Heart meridian Intervention in the Lung meridian: moxibustion will be performed above the acupoint LU5 of the Lung meridian.

Primary Outcome Measure Information:

Title

Temperature change of relevant sites

Description

Infrared thermal imaging is used to record baseline temperature and the temperature change of corresponding sites along the Heart and Lung meridians.

Time Frame

Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion criteria for COPD Patients should meet the above diagnostic criteria, and the severity of COPD is in the stage of GOLD 2 or 3 based on pulmonary function testing; COPD patients in the stable phase, who present with mild symptoms of cough, expectoration and short breath; 35 ≤ age ≤75 years, male or female; Patients have clear consciousness and could communicate with others normally; Patients could understand the full study protocol and have high adherence.Written informed consent is signed by themselves or their lineal kin. Inclusion criteria for health volunteers Healthy volunteers who could provide a recent medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease; 35 ≤ age ≤75 years, male or female; Participants have clear consciousness and could communicate with others normally; Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin. Exclusion Criteria: Exclusion criteria for COPD Patients who fail to meet the diagnostic criteria for COPD, or COPD patients in the phase of acute exacerbation; Patients have the following complications, which includes pneumonia, bronchial asthma, bronchiectasis, active tuberculosis, pneumothorax, chest trauma, tumors of the lung or thorax, and other confirmed respiratory diseases; Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris (CSAP); Patients have serious concomitant conditions and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological, and nervous system; Patients have mental illness, severe depression, alcohol dependence or history of drug abuse; Pregnant or lactating patients; Patients are participating in other trials. Exclusion criteria of health volunteers Participants have mental illness, severe depression, alcohol dependence or history of drug abuse; Pregnant or lactating participants ; Participants are participating in other trials.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongliang Jiang, Ph.D

Phone

86-13858173136

jyl2182@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hantong Hu

Phone

86-18667103032

413351308@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianqiao Fang, Ph.D

Organizational Affiliation

Zhejiang Chinese Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the Third affiliated hospital of Zhejiang Chinese Medical university

City

Hanzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hantong Hu

Phone

86-18667103032

413351308@qq.com

First Name & Middle Initial & Last Name & Degree

Xiaoyu Li

Phone

86-15017541803

752616172@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31254681

Citation

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Results Reference

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Citation

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PubMed Identifier

29231602

Citation

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PubMed Identifier

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Citation

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Results Reference

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Citation

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Results Reference

derived

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The Difference in Heat Transport Characteristics of the Heart and Lung Meridians

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