Chronic Obstructive Pulmonary DiseaseNCT04046640
A Study on the Heat Transport Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Stable Angina Pectoris
An observational study of Chronic Obstructive Pulmonary Disease, run by Zhejiang Chinese Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Infrared thermal imaging
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2020to Dec 2021
- Phase
- Observational
- 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 65 years
- All sexes
- Adult, Older adult
Study population: 40 patients with chronic stable angina pectoris (CSAP) and 40 healthy volunteer.
Who may be able to join
- Patients should meet the diagnostic criteria of coronary heart disease, which includes the following items: 1)confirmed old myocardial infarction (MI), or a history of percutaneous coronary intervention(PCI), or coronary artery bypass grafting; 2)50% or more luminal stenosis in at least one coronary artery or major branch segment confirmed by coronary angiogram or CT angiography; 3) myocardial ischemia indicted by exercise stress radionuclide myocardial imaging; 4) treadmill exercise testing is positive (for male patients);
- Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
- The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
- 35 ≤ age ≤65 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.
Show all 10Show fewer
- Healthy volunteers who could provide a recent (in the past 3 month) medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
- 35 ≤ age ≤65 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 with acute coronary syndrome (including acute myocardial infarction and unstable angina) and severe arrhythmias (such as severe atrioventricular block, ventricular tachycardia, supraventricular tachycardia, frequent premature beats and premature ventricular contraction);
- Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
- Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
- Patients have concomitant conditions of lung diseases, such as chronic obstructive pulmonary disease (COPD);
- Patients have serious concomitant conditions and 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;
Show all 12Show fewer
- Pregnant or lactating patients;
- Patients are participating in other trials.
- Participants have sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.
- 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.
China1 site, 1 recruiting
- 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
About this study
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 thermal imaging. 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 diagnosed with chronic stable angina pectoris (CSAP) and 40 healthy volunteers. Infrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. In addition, by comparing the heat transport characteristics in the acupoints along the Heart and Lung meridians, the relative specificity of the two meridians will also be investigated.
Primary outcomes will be infrared thermal images and acupoint temperature. Furthermore, this study will build standardized techniques and schemes for detecting the heat transport characteristics of meridian phenomenon for Heart and Lung. The results of this study could also provide scientific foundation for traditional meridian theories.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Infrared thermal imaging
- 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 thermal imagingDevice
Infrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for participants in the two groups.
- Experimental device: a NEC InfRec R450 infrared thermal imaging camera
- Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. The height and angle of the infrared thermal imaging camera is adjusted so that the measurement sites of the participant's arm is located in the center of the camera screen. The infrared thermal imaging and acupoint temperature will be recorded for 5 minutes.
- Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.
| Study group | Role | What they receive |
|---|---|---|
| CSAP group | This group will include 40 patients with chronic stable angina pectoris (CSAP). Receives: Device: Infrared thermal imaging | |
| Healthy group | This group will include 40 healthy volunteers. Receives: Device: Infrared thermal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infrared thermal images
Infrared thermal images could reflect the heat transport characteristics of meridian phenomenon.
Measured: 5 minutes
Acupoint temperature
Acupoint temperature could reflect the heat transport characteristics of meridian phenomenon.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study startFeb 2020 (estimated)
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Responsible party
- Principal investigator, Jianqiao Fang, Zhejiang Chinese Medical University
- Investigators
- Jianqiao Fang, Principal investigator, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046640
- Sponsor's protocol ID
- 2019ZY003-MERIDIAN
- Status last verified
- Jan 2020
- First submitted
- 1 Aug 2019
- Last updated
- 22 Jan 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 31254681Alvarez-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 31015854Lin 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 29231602Fu 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 27286712de 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 27495129Yang 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 25780719Zheng 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 24327822Kang 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 23596810Jiang Y, Li X, He X, Hu H, Zhang Y, Shao X, Fang J. The specificity for the correlation between viscera and somato in chronic stable angina pectoris patients and healthy controls: An assessor-blinded and comparative trial. PLoS One. 2025 Sep 26;20(9):e0331868. doi: 10.1371/journal.pone.0331868. eCollection 2025.
PubMed 41004484
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Heat Transport Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT04046640
- Acronym / sponsor ID
- 2019ZY003-MERIDIAN
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, infrared thermography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 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
- Feb 2020 (estimated)
- 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.
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 thermal imaging. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.
Detailed description
This study will include 40 patients diagnosed with chronic stable angina pectoris (CSAP) and 40 healthy volunteers. Infrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. In addition, by comparing the heat transport characteristics in the acupoints along the Heart and Lung meridians, the relative specificity of the two meridians will also be investigated.
Primary outcomes will be infrared thermal images and acupoint temperature. Furthermore, this study will build standardized techniques and schemes for detecting the heat transport characteristics of meridian phenomenon for Heart and Lung. The results of this study could also provide scientific foundation for traditional meridian theories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSAP group | – | Device: Infrared thermal imagingThis group will include 40 patients with chronic stable angina pectoris (CSAP). |
| Healthy group | – | Device: Infrared thermal imagingThis group will include 40 healthy volunteers. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 40 patients with chronic stable angina pectoris (CSAP) and 40 healthy volunteer.
Key inclusion criteria (10 listed)
- Patients should meet the diagnostic criteria of coronary heart disease, which includes the following items: 1)confirmed old myocardial infarction (MI), or a history of percutaneous coronary intervention(PCI), or coronary artery bypass grafting; 2)50% or more luminal stenosis in at least one coronary artery or major branch segment confirmed by coronary angiogram or CT angiography; 3) myocardial ischemia indicted by exercise stress radionuclide myocardial imaging; 4) treadmill exercise testing is positive (for male patients);
- Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
- The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
- 35 ≤ age ≤65 years, male or female;
- Patients have clear consciousness and could communicate with others normally;
Key exclusion criteria (12 listed)
- Patients with acute coronary syndrome (including acute myocardial infarction and unstable angina) and severe arrhythmias (such as severe atrioventricular block, ventricular tachycardia, supraventricular tachycardia, frequent premature beats and premature ventricular contraction);
- Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
- Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
- Patients have concomitant conditions of lung diseases, such as chronic obstructive pulmonary disease (COPD);
- Patients have serious concomitant conditions and and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological and nervous system;
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 thermal imagingInfrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for participants in the two groups. 1. Experimental device: a NEC InfRec R450 infrared thermal imaging camera 2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. The height and angle of the infrared thermal imaging camera is adjusted so that the measurement sites of the participant's arm is located in the center of the camera screen. The infrared thermal imaging and acupoint temperature will be recorded for 5 minutes. 3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian. | Device | CSAP group, Healthy group |
Primary outcome
Infrared thermal images
Time frame: 5 minutes
Infrared thermal images could reflect the heat transport characteristics of meridian phenomenon.
Acupoint temperature
Time frame: 5 minutes
Acupoint temperature could reflect the heat transport characteristics of meridian phenomenon.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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 41004484Jiang Y, Li X, He X, Hu H, Zhang Y, Shao X, Fang J. The specificity for the correlation between viscera and somato in chronic stable angina pectoris patients and healthy controls: An assessor-blinded and comparative trial. PLoS One. 2025 Sep 26;20(9):e0331868. doi: 10.1371/journal.pone.0331868. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Jianqiao Fang 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?
An observational study of 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 10 inclusion and 12 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 22 Jan 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 (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?
Infrared thermal images (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 NCT04046640, 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 22 Jan 2020.