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

Sponsor
Zhejiang Chinese Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04242030
Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University (Other)
120
1
3
22
5.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Moxibustion
  • Device: Laser doppler flowmetry
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Microcirculatory Characteristics of the Heart and Lung Meridians: A Study of COPD Patients and Healthy Adults
Anticipated Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

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

Experimental: Healthy intervention group

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

Other: Moxibustion
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.

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline blood flow curve [5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion]

    Laser doppler flowmetry is used to assess blood flow curve of relevant sites along the Heart and Lung meridians

  2. Change from baseline blood perfusion units [5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion]

    Laser doppler flowmetry is used to assess blood perfusion units of relevant sites along the Heart and Lung meridians

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Third affiliated hospital of Zhejiang Chinese Medical university Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Zhejiang Chinese Medical University
  • The Third Affiliated hospital of Zhejiang Chinese Medical University

Investigators

  • Principal Investigator: Jianqiao Fang, Zhejiang Chinese Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jianqiao Fang, President, Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier:
NCT04242030
Other Study ID Numbers:
  • 2019ZY007
First Posted:
Jan 27, 2020
Last Update Posted:
Jan 30, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jianqiao Fang, President, Zhejiang Chinese Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2020