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Status unknownNCT04242030Updated Jan 30, 2020

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

An interventional study of Moxibustion and Laser doppler flowmetry in Chronic Obstructive Pulmonary Disease, sponsored by Zhejiang Chinese Medical University. Status unknown at 1 site in China. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Zhejiang Chinese Medical University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • meridians
  • acupuncture
  • chronic obstructive pulmonary disease
  • meridian phenomena
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Zhejiang Chinese Medical University is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

Inclusion criteria for COPD patients

  • 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.

Inclusion criteria for healthy volunteers

  • 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;
  • 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.

Exclusion Criteria:

Exclusion criteria for COPD patients

  • 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.

Exclusion criteria of healthy volunteers

  • Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
  • Pregnant or lactating participants ;
  • Participants are participating in other trials
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    COPD group

    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.

    Device: Laser doppler flowmetry

  • Other
    Healthy control group

    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.

    Device: Laser doppler flowmetry

  • Experimental
    Healthy intervention group

    Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.

    Other: Moxibustion · Device: Laser doppler flowmetry

Interventions

  • OtherMoxibustion

    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.

  • DeviceLaser doppler flowmetry

    Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena for the Heart meridian and Lung meridians.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion

  2. 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

    Time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion

07

Study locations

1 site
  • the Third affiliated hospital of Zhejiang Chinese Medical university
    Hangzhou, Zhejiang 310000, China
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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04242030
Lead sponsor
Zhejiang Chinese Medical University
Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University
Responsible party
Jianqiao Fang (President, Zhejiang Chinese Medical University) — Principal investigator
First posted
Jan 27, 2020
Start date
Feb 2020 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jan 30, 2020

Study contacts

Yongliang Jiang
Contact
jyl2182@126.com
86-13858173136
Hantong Hu
Contact
413351308@qq.com
86-18667103032
Jianqiao Fang
principal investigator · Zhejiang Chinese Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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