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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: Moxibustion; Diagnostic Test: Infrared thermography

• Registration Number: NCT04046588
• Lead Sponsor: Zhejiang Chinese Medical University

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.

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Study Start: 2019-10-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy intervention group	Moxibustion	This study will include 40 healthy adults. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively.
COPD group	Infrared thermography	This group will include 40 patients with chronic obstructive pulmonary disease (COPD).
Healthy control group	Infrared thermography	This group will include 40 healthy volunteers.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

the Third affiliated hospital of Zhejiang Chinese Medical university; 🇨🇳 Hanzhou, Zhejiang, China