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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Laser doppler flowmetry; Other: Moxibustion

• Registration Number: NCT04242030
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-27
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30
• Study Start: 2020-02
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COPD group	Laser doppler flowmetry	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.
Healthy intervention group	Laser doppler flowmetry	Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.
Healthy control group	Laser doppler flowmetry	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.
Healthy intervention group	Moxibustion	Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

the Third affiliated hospital of Zhejiang Chinese Medical university; 🇨🇳 Hangzhou, Zhejiang, China