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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046588
• Other study ID #: 2019ZY006-MERIDIAN
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Zhejiang Chinese Medical University
• Contact: Yongliang Jiang, Ph.D
• Phone: 86-13858173136
• Email: jyl2182[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

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.

Locations

Country	Name	City	State
China	the Third affiliated hospital of Zhejiang Chinese Medical university	Hanzhou	Zhejiang

Sponsors (3)

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

Country where clinical trial is conducted

China, 

References & Publications (8)

Álvarez-Prats D, Carvajal-Fernández O, Valera Garrido F, Pecos-Martín D, García-Godino A, Santafe MM, Medina-Mirapeix F. Acupuncture Points and Perforating Cutaneous Vessels Identified Using Infrared Thermography: A Cross-Sectional Pilot Study. Evid Based Complement Alternat Med. 2019 Mar 21;2019:7126439. doi: 10.1155/2019/7126439. eCollection 2019. — View Citation

Cai W, Chen AW, Ding L, Shen WD. Thermal Effects of Acupuncture by the Infrared Thermography Test in Patients With Tinnitus. J Acupunct Meridian Stud. 2019 Aug;12(4):131-135. doi: 10.1016/j.jams.2019.05.002. Epub 2019 Jun 27. — View Citation

de Souza RC, Pansini M, Arruda G, Valente C, Brioschi ML. Laser acupuncture causes thermal changes in small intestine meridian pathway. Lasers Med Sci. 2016 Nov;31(8):1645-1649. Epub 2016 Aug 5. — View Citation

Fu Y, Ni JX, Marmori F, Zhu Q, Tan C, Zhao JP. Infrared thermal imaging-based research on the intermediate structures of the lung and large intestine exterior-interior relationship in asthma patients. Chin J Integr Med. 2016 Nov;22(11):855-860. Epub 2016 Jun 9. — View Citation

Kang J, Lee N, Ahn Y, Lee H. Study on improving blood flow with Korean red ginseng substances using digital infrared thermal imaging and Doppler sonography: randomized, double blind, placebo-controlled clinical trial with parallel design. J Tradit Chin Med. 2013 Feb;33(1):39-45. — View Citation

Lin M, Wei H, Zhao L, Zhao J, Cheng K, Deng H, Shen X, Zhang H. [Review on infrared temperature characteristics of acupoints in recent 10 years]. Zhongguo Zhen Jiu. 2017 Apr 12;37(4):453-456. doi: 10.13703/j.0255-2930.2017.04.028. Review. Chinese. — View Citation

Yang H, Park H, Lim C, Park S, Lee K. Infrared thermal imaging in patients with medial collateral ligament injury of the knee - a retrospective study. J Pharmacopuncture. 2014 Dec;17(4):50-4. doi: 10.3831/KPI.2014.17.036. — View Citation

Zheng J, Zhao Y, Wang Y, Hu S, Lu P, Shen X. The infrared radiation temperature characteristic of acupoints of mammary gland hyperplasia patients. Evid Based Complement Alternat Med. 2013;2013:567987. doi: 10.1155/2013/567987. Epub 2013 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion