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

Sponsor
Zhejiang Chinese Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04046588
Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University (Other), The First Affiliated Hospital of Zhejiang Chinese Medical University (Other)
120
1
3
26
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Infrared thermography
  • Procedure: Moxibustion
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Difference in Heat Transport Characteristics of the Heart and Lung Meridians: a Comparative Study of COPD Patients and Healthy Subjects
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: COPD group

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

Diagnostic Test: Infrared thermography
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.

Other: Healthy control group

This group will include 40 healthy volunteers.

Diagnostic Test: Infrared thermography
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.

Experimental: Healthy intervention group

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

Procedure: Moxibustion
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.
Other Names:
  • Infrared thermography
  • Outcome Measures

    Primary Outcome Measures

    1. Temperature change of relevant sites [Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Inclusion criteria for COPD

    1. 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;

    2. COPD patients in the stable phase, who present with mild symptoms of cough, expectoration and short breath;

    3. 35 ≤ age ≤75 years, male or female;

    4. Patients have clear consciousness and could communicate with others normally;

    5. 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

    1. 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;

    2. 35 ≤ age ≤75 years, male or female;

    3. Participants have clear consciousness and could communicate with others normally;

    4. 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

    1. Patients who fail to meet the diagnostic criteria for COPD, or COPD patients in the phase of acute exacerbation;

    2. 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;

    3. Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris (CSAP);

    4. Patients have serious concomitant conditions and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological, and nervous system;

    5. Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;

    6. Pregnant or lactating patients; Patients are participating in other trials.

    Exclusion criteria of health volunteers

    1. Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;

    2. Pregnant or lactating participants ;

    3. Participants are participating in other trials.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the Third affiliated hospital of Zhejiang Chinese Medical university Hanzhou Zhejiang China 310000

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jianqiao Fang, Ph.D, Zhejiang Chinese Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jianqiao Fang, President, Zhejiang Chinese Medical University
    ClinicalTrials.gov Identifier:
    NCT04046588
    Other Study ID Numbers:
    • 2019ZY006-MERIDIAN
    First Posted:
    Aug 6, 2019
    Last Update Posted:
    Mar 6, 2020
    Last Verified:
    Mar 1, 2020
    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 Jianqiao Fang, President, Zhejiang Chinese Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 6, 2020