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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242030
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Information provided by (Responsible Party):
Jianqiao Fang, Zhejiang Chinese Medical University

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
Chronic Obstructive Pulmonary Disease Other: Moxibustion Device: Laser doppler flowmetry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Change from baseline blood flow curve [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242030


Contacts
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Contact: Yongliang Jiang 86-13858173136 jyl2182@126.com
Contact: Hantong Hu 86-18667103032 413351308@qq.com

Locations
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China, Zhejiang
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China, 310000
Contact: Xiaoyu Li    86-15017541803    752616172@qq.com   
Sponsors and Collaborators
Zhejiang Chinese Medical University
The Third Affiliated hospital of Zhejiang Chinese Medical University
Investigators
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Principal Investigator: Jianqiao Fang Zhejiang Chinese Medical University
Publications:
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Responsible Party: Jianqiao Fang, President, Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier: NCT04242030    
Other Study ID Numbers: 2019ZY007
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianqiao Fang, Zhejiang Chinese Medical University:
meridians
acupuncture
chronic obstructive pulmonary disease
meridian phenomena
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases