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

NCT ID: NCT04046588

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

COPD group

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

Group Type: OTHER

Infrared thermography

Intervention Type: DIAGNOSTIC_TEST

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.

Healthy control group

This group will include 40 healthy volunteers.

Group Type: OTHER

Infrared thermography

Intervention Type: DIAGNOSTIC_TEST

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.

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.

Group Type: EXPERIMENTAL

Moxibustion

Intervention Type: PROCEDURE

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.

1. Intervention in the Heart meridian: moxibustion will be performed above the acupoint HT3 of the Heart meridian

2. Intervention in the Lung meridian: moxibustion will be performed above the acupoint LU5 of the Lung meridian.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

1. Intervention in the Heart meridian: moxibustion will be performed above the acupoint HT3 of the Heart meridian

2. Intervention in the Lung meridian: moxibustion will be performed above the acupoint LU5 of the Lung meridian.

Intervention Type: PROCEDURE

Other Intervention Names

Infrared thermography

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: collaborator

Zhejiang Chinese Medical University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jianqiao Fang

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianqiao Fang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Chinese Medical University

Locations

the Third affiliated hospital of Zhejiang Chinese Medical university

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongliang Jiang, Ph.D

Role: CONTACT

jyl2182@126.com

86-13858173136

Hantong Hu

Role: CONTACT

413351308@qq.com

86-18667103032

Facility Contacts

Hantong Hu

Role: primary

413351308@qq.com

86-18667103032

Xiaoyu Li

Role: backup

752616172@qq.com

86-15017541803

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Other Identifiers

2019ZY006-MERIDIAN

Identifier Type: -

Identifier Source: org_study_id