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

Study Overview
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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. 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.

Detailed Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Moxibustion
* Device: Laser doppler flowmetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COPD group<br>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<br>* Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena for the Heart meridian and Lung meridians.<br>|
| Other: Healthy control group<br>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<br>* Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena for the Heart meridian and Lung meridians.<br>|
| Experimental: Healthy intervention group<br>Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians. | Other: Moxibustion<br>* 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.<br>Device: Laser doppler flowmetry<br>* Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena for the Heart meridian and Lung meridians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomena