Chronic Obstructive Pulmonary DiseaseNCT04046588

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

A study testing Infrared thermography and Moxibustion in people with Chronic Obstructive Pulmonary Disease, run by Zhejiang Chinese Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 35 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Infrared thermography and Moxibustion
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 1 Oct 2019to Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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;

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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.

Who cannot join

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.

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

Yongliang Jiang, Ph.D contact

Hantong Hu contact

China1 site, 1 recruiting

the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, 310000
Hantong Hu, 86-18667103032, 413351308@qq.com
Xiaoyu Li, 86-15017541803, 752616172@qq.com
Recruiting

Other trials in China

About this study

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

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.

Read the 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
Being tested: Infrared thermography, Moxibustion
Keywords: meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, infrared thermography
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Infrared thermographyDiagnostic 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.
MoxibustionProcedure or surgery
Also called Infrared thermography
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.

Study groups in NCT04046588
Study group	Role	What they receive
COPD group	Other	This group will include 40 patients with chronic obstructive pulmonary disease (COPD). Receives: Diagnostic Test: Infrared thermography
Healthy control group	Other	This group will include 40 healthy volunteers. Receives: Diagnostic Test: Infrared thermography
Healthy intervention group	Experimental	This study will include 40 healthy adults. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. Receives: Procedure: Moxibustion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 2019Dec 2021

First posted6 Aug 2019
Study start1 Oct 2019
Primary completionDec 2020 (estimated)
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04046588
Sponsor's protocol ID: 2019ZY006-MERIDIAN
Status last verified: Mar 2020
First submitted: 2 Aug 2019
Last updated: 6 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31254681
Alvarez-Prats D, Carvajal-Fernandez O, Valera Garrido F, Pecos-Martin D, Garcia-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.
PubMed 31015854
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. Chinese.
PubMed 29231602
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. doi: 10.1007/s11655-016-2102-4. Epub 2016 Jun 9.
PubMed 27286712
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. doi: 10.1007/s10103-016-2032-6. Epub 2016 Aug 5.
PubMed 27495129
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.
PubMed 25780719
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.
PubMed 24327822
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. doi: 10.1016/s0254-6272(13)60098-9.
PubMed 23596810
Li X, Jiang Y, Hu H, Zhang Y, Lou J, He X, Sun J, Wu Y, Fang J, Shao X, Fang J. The difference in heat transport characteristics of the heart and lung meridians: A comparative study of COPD patients and healthy subjects. Medicine (Baltimore). 2021 Feb 5;100(5):e23804. doi: 10.1097/MD.0000000000023804.
PubMed 33592838

Want to know more?

Yongliang Jiang, Ph.D

86-13858173136

jyl2182@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Difference in Heat Transport Characteristics of the Heart and Lung Meridians: a Comparative Study of COPD Patients and Healthy Subjects
ClinicalTrials.gov ID: NCT04046588
Acronym / sponsor ID: 2019ZY006-MERIDIAN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, infrared thermography
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Zhejiang Chinese Medical UniversityOther government
Collaborators: The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University
Study start: 1 Oct 2019 (actual)
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 6 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
COPD group	Other	Diagnostic Test: Infrared thermographyThis group will include 40 patients with chronic obstructive pulmonary disease (COPD).
Healthy control group	Other	Diagnostic Test: Infrared thermographyThis group will include 40 healthy volunteers.
Healthy intervention group	Experimental	Procedure: MoxibustionThis study will include 40 healthy adults. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively.

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Infrared thermographyA 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.	Diagnostic test	COPD group, Healthy control group
MoxibustionAlso: Infrared thermographyTwo 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.	Procedure or surgery	Healthy intervention group

Primary outcome

Temperature change of relevant sites
Time frame: 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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
Background: PubMed 31254681Cai 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.
Background: PubMed 31015854Alvarez-Prats D, Carvajal-Fernandez O, Valera Garrido F, Pecos-Martin D, Garcia-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.
Background: PubMed 29231602Lin 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. Chinese.
Background: PubMed 27286712Fu 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. doi: 10.1007/s11655-016-2102-4. Epub 2016 Jun 9.
Background: PubMed 27495129de 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. doi: 10.1007/s10103-016-2032-6. Epub 2016 Aug 5.
Background: PubMed 25780719Yang 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.
Background: PubMed 24327822Zheng 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.
Background: PubMed 23596810Kang 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. doi: 10.1016/s0254-6272(13)60098-9.
Derived from this study: PubMed 33592838Li X, Jiang Y, Hu H, Zhang Y, Lou J, He X, Sun J, Wu Y, Fang J, Shao X, Fang J. The difference in heat transport characteristics of the heart and lung meridians: A comparative study of COPD patients and healthy subjects. Medicine (Baltimore). 2021 Feb 5;100(5):e23804. doi: 10.1097/MD.0000000000023804.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yongliang Jiang, Ph.D contact

Hantong Hu contact

Jianqiao Fang, Ph.D principal investigator

Zhejiang Chinese Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Infrared thermography and Moxibustion in people with Chronic Obstructive Pulmonary Disease, run by Zhejiang Chinese Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongliang Jiang, Ph.D (86-13858173136, jyl2182@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temperature change of relevant sites (time frame: Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04046588, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.