A Study on the Microcirculatory Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With COPD

NCT04045418 | Unknown DMC

• 1 other identifier: 2019ZY004-MERIDIAN
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes.Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study is designed to assess the microcirculatory characteristics of meridian phenomenon for the Heart and Lung meridians by using laser doppler. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

meridians; acupuncture; chronic stable angina pectoris; meridian phenomenon; laser doppler

Outcome Measures

Primary Outcomes (2)

• Blood flow curve

  The blood flow curve could reflect the microcirculatory flux in the measuring sites.

  5 minutes of baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion.

• Blood perfusion units

  Perfusion units (PU)=concentration of moving blood cells (CMBC)×velocity (V)

  5 minutes of baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion.

Study Arms (3)

COPD group

This group will include 40 patients with chronic obstructive pulmonary disease (COPD).

Device: Laser doppler

Healthy control group

This group will include 40 healthy volunteers.

Device: Laser doppler

Healthy intervention group

This group will include 40 healthy volunteers. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. The washout period between the two sessions is at least one day.

Device: Laser doppler

Interventions

Laser doppler DEVICE

A laser doppler flowmetry will be used to measure the microcirculatory characteristics of meridian phenomena. The probes will be left at relevant measuring sites. Blood flow curve and Perfusion units (PU ) will be recorded constantly. 1. Healthy control group and COPD group The probes will be left at Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian for 5 minutes. 2. Healthy intervention group Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.

Also known as: moxibustion

COPD group; Healthy control group; Healthy intervention group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 patients with chronic obstructive pulmonary disease (COPD)and 80 healthy volunteers.

You may qualify if:

• Patients should meet the above 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, who present with mild symptoms of cough, expectoration and short breath;
• ≤ age ≤75 years, male or female;
• Patients have clear consciousness and could communicate with others normally;
• Patients could understand the full study protocol and have high adherence.Written informed consent is signed by themselves or their lineal kin.
• Healthy volunteers who could provide a recent (in the past 3 month) 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 have high adherence .Written informed consent is signed by themselves or their lineal kin.

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, which includes pneumonia, bronchial asthma, bronchiectasis, active tuberculosis, pneumothorax, chest trauma, tumors of the lung or thorax, and other confirmed respiratory diseases;
• Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris (CSAP);
• 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 sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.
• Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
• Pregnant or lactating participants ;
• Participants are participating in other trials.

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead
• The Third Affiliated hospital of Zhejiang Chinese Medical University: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hanzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (8)

• 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: 17906382 BACKGROUND

• Hsiu H, Hsu WC, Chen BH, Hsu CL. Differences in the microcirculatory effects of local skin surface contact pressure stimulation between acupoints and nonacupoints: possible relevance to acupressure. Physiol Meas. 2010 Jun;31(6):829-41. doi: 10.1088/0967-3334/31/6/007. Epub 2010 May 18.

  PMID: 20479520 BACKGROUND

• 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: 19162851 BACKGROUND

• Hsiu H, Hsu WC, Hsu CL, Huang SM, Lin YY. Microcirculatory changes by laser Doppler after infrared heating over acupuncture points--relevance to moxibustion. Photomed Laser Surg. 2009 Dec;27(6):855-61. doi: 10.1089/pho.2008.2390.

  PMID: 19698003 BACKGROUND

• Hsiu H, Huang SM, Chao PT, Hsu WC, Hsu CL, Jan MY, Wang WK, Wang YY. Study on the microcirculatory blood velocity of acupoint monitored by laser Doppler signal. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:959-62. doi: 10.1109/IEMBS.2007.4352451.

  PMID: 18002117 BACKGROUND

• Litscher G, Wang L, Huber E, Nilsson G. Changed skin blood perfusion in the fingertip following acupuncture needle introduction as evaluated by laser Doppler perfusion imaging. Lasers Med Sci. 2002;17(1):19-25. doi: 10.1007/s10103-002-8262-9.

  PMID: 11845364 BACKGROUND

• 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: 18504639 BACKGROUND

• Huang T, Wang RH, Zhang WB, Han B, Wang GJ, Tian YY, Zhang YQ. The influence of different methods of acupuncture on skin surface perfusion. J Tradit Chin Med. 2012 Mar;32(1):40-4. doi: 10.1016/s0254-6272(12)60029-6.

  PMID: 22594100 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Laser-Doppler Flowmetry; Moxibustion

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques; Acupuncture Therapy; Complementary Therapies; Therapeutics

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)