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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

120

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline

Completed

Started Feb 2020

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

January 21, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed

5 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed

Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

January 21, 2020

Last Update Submit

January 29, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

meridiansacupuncturechronic obstructive pulmonary diseasemeridian phenomena

Outcome Measures

Primary Outcomes (2)

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

Study Arms (3)

COPD group

OTHER

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

Healthy control group

OTHER

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

Healthy intervention group

EXPERIMENTAL

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

Other: MoxibustionDevice: Laser doppler flowmetry

Interventions

MoxibustionOTHER

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.

Healthy intervention group

Laser doppler flowmetryDEVICE

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

COPD groupHealthy control groupHealthy intervention group

Eligibility Criteria

Age20 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;
≤ 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.
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.

You may not qualify if:

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.
Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
Pregnant or lactating participants ;
Participants are participating in other trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (5)

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.
PMID: 18504639BACKGROUND
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.
PMID: 19162851BACKGROUND
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.
PMID: 17906382BACKGROUND
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.
PMID: 22574570BACKGROUND
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.
PMID: 24118419BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

MoxibustionLaser-Doppler Flowmetry

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRheologyInvestigative Techniques

Study Officials

Jianqiao Fang
Zhejiang Chinese Medical University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongliang Jiang

CONTACT

86-13858173136 jyl2182@126.com

Hantong Hu

CONTACT

86-18667103032 413351308@qq.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: President

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

February 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (3)

COPD group

Healthy control group

Healthy intervention group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations