Chronic Obstructive Pulmonary DiseaseNCT04045418

A Study on the Microcirculatory Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With COPD

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Laser doppler
Type of treatment: Medical device
How many people: 120 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 20 to 75 years
All sexes
Adult, Older adult

Study population: 40 patients with chronic obstructive pulmonary disease (COPD)and 80 healthy volunteers.

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 (in the past 3 month) medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;

Show all 9Show fewer

age ≥20 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 10Show fewer

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.

Yongliang Jiang 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: A Study on the Microcirculatory Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Chronic Obstructive Pulmonary Disease

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 microcirculatory characteristics of meridian phenomenon for the Heart and Lung meridians by using laser doppler. 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 obstructive pulmonary disease (COPD) and 80 healthy volunteers. Laser doppler examination will be adopted to assess the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. Moreover, the site specificity for the meridian-visceral association and surface-surface association between the Heart and Lung meridians will be investigated.Primary outcomes will be blood flow curve and blood perfusion units(PU).Furthermore, this study will build standardized techniques and schemes for detecting the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians. The results of this study could also provide scientific foundation for traditional meridian theories.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Laser doppler
Keywords: meridians, acupuncture, chronic stable angina pectoris, meridian phenomenon, laser doppler
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.

Laser dopplerDevice
Also called moxibustion
A laser doppler flowmetry will be used to measure the microcirculatory characteristics of meridian phenomena. The probes will be left at relevant measuring sites. Blood flow curve and Perfusion units (PU ) will be recorded constantly.
1. Healthy control group and COPD group The probes will be left at Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian for 5 minutes.
2. Healthy intervention group Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.

Study groups in NCT04045418
Study group	Role	What they receive
COPD group		This group will include 40 patients with chronic obstructive pulmonary disease (COPD). Receives: Device: Laser doppler
Healthy control group		This group will include 40 healthy volunteers. Receives: Device: Laser doppler
Healthy intervention group		This group will include 40 healthy volunteers. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. The washout period between the two sessions is at least one day. Receives: Device: Laser doppler

What is being measured

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

Blood flow curve
The blood flow curve could reflect the microcirculatory flux in the measuring sites.
Measured: 5 minutes of baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion.
Blood perfusion units
Perfusion units (PU)=concentration of moving blood cells (CMBC)×velocity (V)
Measured: 5 minutes of 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 posted5 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 (8)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: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04045418
Sponsor's protocol ID: 2019ZY004-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

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
Hsiu H, Hsu WC, Chen BH, Hsu CL. Differences in the microcirculatory effects of local skin surface contact pressure stimulation between acupoints and nonacupoints: possible relevance to acupressure. Physiol Meas. 2010 Jun;31(6):829-41. doi: 10.1088/0967-3334/31/6/007. Epub 2010 May 18.
PubMed 20479520
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, Hsu WC, Hsu CL, Huang SM, Lin YY. Microcirculatory changes by laser Doppler after infrared heating over acupuncture points--relevance to moxibustion. Photomed Laser Surg. 2009 Dec;27(6):855-61. doi: 10.1089/pho.2008.2390.
PubMed 19698003
Hsiu H, Huang SM, Chao PT, Hsu WC, Hsu CL, Jan MY, Wang WK, Wang YY. Study on the microcirculatory blood velocity of acupoint monitored by laser Doppler signal. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:959-62. doi: 10.1109/IEMBS.2007.4352451.
PubMed 18002117
Litscher G, Wang L, Huber E, Nilsson G. Changed skin blood perfusion in the fingertip following acupuncture needle introduction as evaluated by laser Doppler perfusion imaging. Lasers Med Sci. 2002;17(1):19-25. doi: 10.1007/s10103-002-8262-9.
PubMed 11845364
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
Huang T, Wang RH, Zhang WB, Han B, Wang GJ, Tian YY, Zhang YQ. The influence of different methods of acupuncture on skin surface perfusion. J Tradit Chin Med. 2012 Mar;32(1):40-4. doi: 10.1016/s0254-6272(12)60029-6.
PubMed 22594100

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

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

All Chronic Obstructive Pulmonary Disease trials

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 Microcirculatory Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT04045418
Acronym / sponsor ID: 2019ZY004-MERIDIAN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: meridians, acupuncture, chronic stable angina pectoris, meridian phenomenon, laser doppler
Study type: Observational
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: Feb 2020 (estimated)
Primary completion: Dec 2020 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 5 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

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
COPD group	–	Device: Laser dopplerThis group will include 40 patients with chronic obstructive pulmonary disease (COPD).
Healthy control group	–	Device: Laser dopplerThis group will include 40 healthy volunteers.
Healthy intervention group	–	Device: Laser dopplerThis group will include 40 healthy volunteers. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. The washout period between the two sessions is at least one day.

Who may qualify

Ages: 20 to 75 years
Sex: All
Age groups: Adult, Older adult
Study population: 40 patients with chronic obstructive pulmonary disease (COPD)and 80 healthy volunteers.

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 (10 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
Laser dopplerAlso: moxibustionA laser doppler flowmetry will be used to measure the microcirculatory characteristics of meridian phenomena. The probes will be left at relevant measuring sites. Blood flow curve and Perfusion units (PU ) will be recorded constantly. 1. Healthy control group and COPD group The probes will be left at Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian for 5 minutes. 2. Healthy intervention group Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.	Device	COPD group, Healthy control group, Healthy intervention group

Primary outcome

Blood flow curve
Time frame: 5 minutes of baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion.
The blood flow curve could reflect the microcirculatory flux in the measuring sites.
Blood perfusion units
Time frame: 5 minutes of baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion.
Perfusion units (PU)=concentration of moving blood cells (CMBC)×velocity (V)

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 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 20479520Hsiu H, Hsu WC, Chen BH, Hsu CL. Differences in the microcirculatory effects of local skin surface contact pressure stimulation between acupoints and nonacupoints: possible relevance to acupressure. Physiol Meas. 2010 Jun;31(6):829-41. doi: 10.1088/0967-3334/31/6/007. Epub 2010 May 18.
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 19698003Hsiu H, Hsu WC, Hsu CL, Huang SM, Lin YY. Microcirculatory changes by laser Doppler after infrared heating over acupuncture points--relevance to moxibustion. Photomed Laser Surg. 2009 Dec;27(6):855-61. doi: 10.1089/pho.2008.2390.
Background: PubMed 18002117Hsiu H, Huang SM, Chao PT, Hsu WC, Hsu CL, Jan MY, Wang WK, Wang YY. Study on the microcirculatory blood velocity of acupoint monitored by laser Doppler signal. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:959-62. doi: 10.1109/IEMBS.2007.4352451.
Background: PubMed 11845364Litscher G, Wang L, Huber E, Nilsson G. Changed skin blood perfusion in the fingertip following acupuncture needle introduction as evaluated by laser Doppler perfusion imaging. Lasers Med Sci. 2002;17(1):19-25. doi: 10.1007/s10103-002-8262-9.
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 22594100Huang T, Wang RH, Zhang WB, Han B, Wang GJ, Tian YY, Zhang YQ. The influence of different methods of acupuncture on skin surface perfusion. J Tradit Chin Med. 2012 Mar;32(1):40-4. doi: 10.1016/s0254-6272(12)60029-6.
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.

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?

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 9 inclusion and 10 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?

Blood flow curve (time frame: 5 minutes of 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 NCT04045418, which also lists 8 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.