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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Moxibustion

Laser doppler flowmetry

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomena

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

the Third affiliated hospital of Zhejiang Chinese Medical university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Arm Label

COPD group

Healthy control group

Healthy intervention group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04242030

First Posted

January 21, 2020

Last Updated

January 29, 2020

Sponsor

Zhejiang Chinese Medical University

Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04242030

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 2020 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Chinese Medical University

Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomena

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD group

Arm Type

Other

Arm Description

Arm Title

Healthy control group

Arm Type

Other

Arm Description

Arm Title

Healthy intervention group

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Moxibustion

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Laser doppler flowmetry

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline blood flow curve

Description

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

Title

Change from baseline blood perfusion units

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongliang Jiang

Phone

86-13858173136

jyl2182@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hantong Hu

Phone

86-18667103032

413351308@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianqiao Fang

Organizational Affiliation

Zhejiang Chinese Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

the Third affiliated hospital of Zhejiang Chinese Medical university

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoyu Li

Phone

86-15017541803

752616172@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18504639

Citation

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.

Results Reference

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PubMed Identifier

19162851

Citation

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.

Results Reference

background

PubMed Identifier

17906382

Citation

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.

Results Reference

background

PubMed Identifier

22574570

Citation

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.

Results Reference

background

PubMed Identifier

24118419

Citation

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.

Results Reference

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

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