Chronic Obstructive Pulmonary DiseaseNCT04242030

The Microcirculatory Characteristics of the Heart and Lung Meridians: A Study of COPD Patients and Healthy Adults

A study testing Moxibustion and Laser doppler flowmetry 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 The sponsor has not verified this record for over two years, so it may be out of date.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 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Moxibustion and Laser doppler flowmetry
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: Feb 2020to 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 20 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients should meet the COPD 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 and present with mild symptoms;
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 written informed consent is signed.
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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age ≥20 years, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and written informed consent is signed.

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, such as bronchial asthma, bronchiectasis, active tuberculosis, pneumothorax, chest trauma, tumors of the lung or thorax;
Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris;
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.

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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 contact

Hantong Hu contact

China1 site

the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, 310000
Xiaoyu Li, 86-15017541803, 752616172@qq.com

Other trials in China

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. The majority of the existing studies involve lots of subjective assessments for meridian phenomena. In addition, few studies have investigated the site specificity between two specific meridians.Therefore, this study is designed to detect the microcirculatory characteristics of meridian phenomena by using an objective assessment tool and investigate the site specificity for the meridian-visceral association and surface-surface association between two specific meridians.

Read the detailed description

The Lung and Heart meridians are chosen as two specific studied meridians. 120 participants will be enrolled and divided into the healthy control group, chronic obstructive pulmonary disease (COPD) group and healthy intervention group. Laser doppler flowmetry (LDF) will be used to assess the microcirculatory characteristics of meridian phenomena for the Heart and Lung meridians. The site specificity for the meridian-visceral association will be investigated by comparing the microcirculatory difference between the Heart and Lung meridians in the healthy control group and COPD group. Besides, participants in the healthy intervention group will receive two sessions of moxibustion in the Heart meridian and Lung meridian respectively to explore the site specificity for the surface-surface association.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Moxibustion, Laser doppler flowmetry
Keywords: meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomena
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.

MoxibustionOther
Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.
Intervention in the Heart meridian: moxibustion will be performed above Shaohai (HT3) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Heart meridian along the left forearm, Chize (LU5) of the Lung meridian, and the midpoint of the Lung meridian along the left forearm.
Intervention in the Lung meridian: moxibustion will be performed above Chize (LU5) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Lung meridian along the left forearm, Shaohai (HT3) of the Heart meridian, and the midpoint of the Heart meridian along the left forearm.
Laser doppler flowmetryDevice
Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena for the Heart meridian and Lung meridians.

Study groups in NCT04242030
Study group	Role	What they receive
COPD group	Other	Participants in the COPD group will receive examination of laser doppler flowmetry(LDF). The LDF probes will be left at 4 measuring acupoints, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian. Receives: Device: Laser doppler flowmetry
Healthy control group	Other	Participants in the healthy control group will receive examination of laser doppler flowmetry(LDF). The LDF probes will be left at 4 measuring acupoints, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian. Receives: Device: Laser doppler flowmetry
Healthy intervention group	Experimental	Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians. Receives: Other: Moxibustion; Device: Laser doppler flowmetry

What is being measured

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

Change from baseline blood flow curve
Laser doppler flowmetry is used to assess blood flow curve of relevant sites along the Heart and Lung meridians
Measured: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion
Change from baseline blood perfusion units
Laser doppler flowmetry is used to assess blood perfusion units of relevant sites along the Heart and Lung meridians
Measured: 5-minute baseline, 15 minutes during moxibustion and 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.

Feb 2020Dec 2021

First posted27 Jan 2020
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 (5)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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04242030
Sponsor's protocol ID: 2019ZY007
Status last verified: Jan 2020
First submitted: 21 Jan 2020
Last updated: 30 Jan 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hsiu H, Hsu WC, Huang SM, Hsu CL, Lin Wang YY. Spectral analysis of the microcirculatory laser Doppler signal at the Hoku acupuncture point. Lasers Med Sci. 2009 May;24(3):353-8. doi: 10.1007/s10103-008-0569-8. Epub 2008 May 27.
PubMed 18504639
Hsiu H, Hsu WC, Hsu CL, Huang SM, Jan MY, Wang WK, Wang YY. Spectral analysis on the microcirculatory laser Doppler signal at the acupuncture point. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:1084-6. doi: 10.1109/IEMBS.2008.4649348.
PubMed 19162851
Hsiu H, Huang SM, Chao PT, Jan MY, Hsu TL, Wang WK, Wang YY. Microcirculatory characteristics of acupuncture points obtained by laser Doppler flowmetry. Physiol Meas. 2007 Oct;28(10):N77-86. doi: 10.1088/0967-3334/28/10/N01. Epub 2007 Sep 18.
PubMed 17906382
Zheng SX, Xu JS, Pan XH, Hu XL. [Comparison of microcirculatory blood perfusion between acupoints of the stomach meridian and their bilateral control points and changes of blood flow after electroacupuncture in 21 volunteer subjects]. Zhen Ci Yan Jiu. 2012 Feb;37(1):53-8. Chinese.
PubMed 22574570
Hsiu H, Hsu WC, Wu YF, Hsu CL, Chen CY. Differences in the skin-surface laser Doppler signals between polycystic ovary syndrome and normal subjects. Microcirculation. 2014 Feb;21(2):124-30. doi: 10.1111/micc.12095.
PubMed 24118419

Want to know more?

Yongliang Jiang

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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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Microcirculatory Characteristics of the Heart and Lung Meridians: A Study of COPD Patients and Healthy Adults
ClinicalTrials.gov ID: NCT04242030
Acronym / sponsor ID: 2019ZY007
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomena
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
Study start: Feb 2020 (estimated)
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 27 Jan 2020 (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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
COPD group	Other	Device: Laser doppler flowmetryParticipants in the COPD group will receive examination of laser doppler flowmetry(LDF). The LDF probes will be left at 4 measuring acupoints, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian.
Healthy control group	Other	Device: Laser doppler flowmetryParticipants in the healthy control group will receive examination of laser doppler flowmetry(LDF). The LDF probes will be left at 4 measuring acupoints, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian.
Healthy intervention group	Experimental	Other: Moxibustion, Device: Laser doppler flowmetryParticipants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients should meet the COPD 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 and present with mild symptoms;
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 written informed consent is signed.

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, such as bronchial asthma, bronchiectasis, active tuberculosis, pneumothorax, chest trauma, tumors of the lung or thorax;
Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris;
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
MoxibustionTwo sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively. Intervention in the Heart meridian: moxibustion will be performed above Shaohai (HT3) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Heart meridian along the left forearm, Chize (LU5) of the Lung meridian, and the midpoint of the Lung meridian along the left forearm. Intervention in the Lung meridian: moxibustion will be performed above Chize (LU5) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Lung meridian along the left forearm, Shaohai (HT3) of the Heart meridian, and the midpoint of the Heart meridian along the left forearm.	Other	Healthy intervention group
Laser doppler flowmetryLaser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena for the Heart meridian and Lung meridians.	Device	COPD group, Healthy control group, Healthy intervention group

Primary outcome

Change from baseline blood flow curve
Time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion
Laser doppler flowmetry is used to assess blood flow curve of relevant sites along the Heart and Lung meridians
Change from baseline blood perfusion units
Time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion
Laser doppler flowmetry is used to assess blood perfusion units of relevant 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 30 Jan 2020.
Background: PubMed 18504639Hsiu H, Hsu WC, Huang SM, Hsu CL, Lin Wang YY. Spectral analysis of the microcirculatory laser Doppler signal at the Hoku acupuncture point. Lasers Med Sci. 2009 May;24(3):353-8. doi: 10.1007/s10103-008-0569-8. Epub 2008 May 27.
Background: PubMed 19162851Hsiu H, Hsu WC, Hsu CL, Huang SM, Jan MY, Wang WK, Wang YY. Spectral analysis on the microcirculatory laser Doppler signal at the acupuncture point. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:1084-6. doi: 10.1109/IEMBS.2008.4649348.
Background: PubMed 17906382Hsiu H, Huang SM, Chao PT, Jan MY, Hsu TL, Wang WK, Wang YY. Microcirculatory characteristics of acupuncture points obtained by laser Doppler flowmetry. Physiol Meas. 2007 Oct;28(10):N77-86. doi: 10.1088/0967-3334/28/10/N01. Epub 2007 Sep 18.
Background: PubMed 22574570Zheng SX, Xu JS, Pan XH, Hu XL. [Comparison of microcirculatory blood perfusion between acupoints of the stomach meridian and their bilateral control points and changes of blood flow after electroacupuncture in 21 volunteer subjects]. Zhen Ci Yan Jiu. 2012 Feb;37(1):53-8. Chinese.
Background: PubMed 24118419Hsiu H, Hsu WC, Wu YF, Hsu CL, Chen CY. Differences in the skin-surface laser Doppler signals between polycystic ovary syndrome and normal subjects. Microcirculation. 2014 Feb;21(2):124-30. doi: 10.1111/micc.12095.
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 contact

Hantong Hu contact

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?

A study testing Moxibustion and Laser doppler flowmetry 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 30 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?

Change from baseline blood flow curve (time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion). 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 NCT04242030, which also lists 5 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 30 Jan 2020.