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

NCT ID: NCT04045418

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-29

Study Completion Date

2021-12-31

Brief Summary

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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

Detailed Description

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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

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD group

This group will include 40 patients with chronic obstructive pulmonary disease (COPD).

Laser doppler

Intervention Type DEVICE

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.

Healthy control group

This group will include 40 healthy volunteers.

Laser doppler

Intervention Type DEVICE

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.

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.

Laser doppler

Intervention Type DEVICE

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.

Interventions

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Laser doppler

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.

Intervention Type DEVICE

Other Intervention Names

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moxibustion

Eligibility Criteria

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Inclusion Criteria

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.


1. 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;
2. age ≥20 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

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.


1. Participants have sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.
2. Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
3. Pregnant or lactating participants ;
4. Participants are participating in other trials.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Zhejiang Chinese Medical University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jianqiao Fang

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianqiao Fang

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Chinese Medical University

Locations

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the Third affiliated hospital of Zhejiang Chinese Medical university

Hanzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongliang Jiang

Role: CONTACT

86-13858173136

Hantong Hu

Role: CONTACT

86-18667103032

Facility Contacts

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Hantong Hu

Role: primary

86-18667103032

Xiaoyu Li

Role: backup

86-15017541803

References

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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.

Reference Type BACKGROUND
PMID: 17906382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20479520 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19162851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19698003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18002117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11845364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18504639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22594100 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2019ZY004-MERIDIAN

Identifier Type: -

Identifier Source: org_study_id

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