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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Study on the Microcirculatory Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045418
• Other study ID #: 2019ZY004-MERIDIAN
• Status: Recruiting
• Start date: February 2020
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Zhejiang Chinese Medical University
• Contact: Yongliang Jiang
• Phone: 86-13858173136
• Email: jyl2182[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

This study will include 40 patients diagnosed with chronic obstructive pulmonary disease (COPD) and 80 healthy volunteers. Laser doppler examination will be adopted to assess the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. Moreover, the site specificity for the meridian-visceral association and surface-surface association between the Heart and Lung meridians will be investigated.Primary outcomes will be blood flow curve and blood perfusion units(PU).Furthermore, this study will build standardized techniques and schemes for detecting the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians. The results of this study could also provide scientific foundation for traditional meridian theories.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for the COPD group

1. 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;

2. COPD patients in the stable phase, who present with mild symptoms of cough, expectoration and short breath;

3. 35 = age =75 years, male or female;

4. Patients have clear consciousness and could communicate with others normally;

5. Patients could understand the full study protocol and have high adherence.Written informed consent is signed by themselves or their lineal kin.

Inclusion criteria for health volunteers

1. 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;

2. age =20 years, male or female;

3. Participants have clear consciousness and could communicate with others normally;

4. Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin.

Exclusion Criteria:

Exclusion criteria for the COPD group

1. Patients who fail to meet the diagnostic criteria for COPD, or COPD patients in the phase of acute exacerbation;

2. 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;

3. Patients have concomitant conditions of heart diseases, such as chronic stable angina pectoris (CSAP);

4. Patients have serious concomitant conditions and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological, and nervous system;

5. Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;

6. Pregnant or lactating patients; Patients are participating in other trials.

Exclusion criteria of health volunteers

1. Participants have sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.

2. Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;

3. Pregnant or lactating participants ;

4. Participants are participating in other trials.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Laser doppler
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. 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. Healthy intervention group Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.

Locations

Country	Name	City	State
China	the Third affiliated hospital of Zhejiang Chinese Medical university	Hanzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Zhejiang Chinese Medical University	The First Affiliated Hospital of Zhejiang Chinese Medical University, The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. Conf Proc IEEE Eng Med Biol Soc. 2008;2008:1084-6. doi: 10.1109/IEMBS.2008.4649348. — View Citation

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. — View Citation

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. — View Citation

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. Conf Proc IEEE Eng Med Biol Soc. 2007;2007:959-62. — View Citation

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. Epub 2007 Sep 18. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.