NCT04046588

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 heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermography. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.

Trial Health

43
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 Oct 2019

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

First Submitted

Initial submission to the registry

August 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.2 years 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

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

August 2, 2019

Last Update Submit

March 4, 2020

Conditions

Keywords

meridiansacupuncturechronic obstructive pulmonary diseasemeridian phenomenoninfrared thermography

Outcome Measures

Primary Outcomes (1)

  • Temperature change of relevant sites

    Infrared thermal imaging is used to record baseline temperature and the temperature change of corresponding sites along the Heart and Lung meridians.

    Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion

Study Arms (3)

COPD group

OTHER

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

Diagnostic Test: Infrared thermography

Healthy control group

OTHER

This group will include 40 healthy volunteers.

Diagnostic Test: Infrared thermography

Healthy intervention group

EXPERIMENTAL

This study will include 40 healthy adults. Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively.

Procedure: Moxibustion

Interventions

Infrared thermographyDIAGNOSTIC_TEST

A thermal imager (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) will be used to record thermal images. The temperature of corresponding sites on the Heart and Lung meridians will be analyzed.

COPD groupHealthy control group
MoxibustionPROCEDURE

Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian, respectivey. During moxibustion, the temperature change of relevant sites in the Heart and Lung meridians will be measured by infrared thermal imaging. 1. Intervention in the Heart meridian: moxibustion will be performed above the acupoint HT3 of the Heart meridian 2. Intervention in the Lung meridian: moxibustion will be performed above the acupoint LU5 of the Lung meridian.

Also known as: Infrared thermography
Healthy intervention group

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
  • ≤ age ≤75 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 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

Hanzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (9)

  • Cai W, Chen AW, Ding L, Shen WD. Thermal Effects of Acupuncture by the Infrared Thermography Test in Patients With Tinnitus. J Acupunct Meridian Stud. 2019 Aug;12(4):131-135. doi: 10.1016/j.jams.2019.05.002. Epub 2019 Jun 27.

    PMID: 31254681BACKGROUND
  • Alvarez-Prats D, Carvajal-Fernandez O, Valera Garrido F, Pecos-Martin D, Garcia-Godino A, Santafe MM, Medina-Mirapeix F. Acupuncture Points and Perforating Cutaneous Vessels Identified Using Infrared Thermography: A Cross-Sectional Pilot Study. Evid Based Complement Alternat Med. 2019 Mar 21;2019:7126439. doi: 10.1155/2019/7126439. eCollection 2019.

    PMID: 31015854BACKGROUND
  • Lin M, Wei H, Zhao L, Zhao J, Cheng K, Deng H, Shen X, Zhang H. [Review on infrared temperature characteristics of acupoints in recent 10 years]. Zhongguo Zhen Jiu. 2017 Apr 12;37(4):453-456. doi: 10.13703/j.0255-2930.2017.04.028. Chinese.

    PMID: 29231602BACKGROUND
  • Fu Y, Ni JX, Marmori F, Zhu Q, Tan C, Zhao JP. Infrared thermal imaging-based research on the intermediate structures of the lung and large intestine exterior-interior relationship in asthma patients. Chin J Integr Med. 2016 Nov;22(11):855-860. doi: 10.1007/s11655-016-2102-4. Epub 2016 Jun 9.

    PMID: 27286712BACKGROUND
  • de Souza RC, Pansini M, Arruda G, Valente C, Brioschi ML. Laser acupuncture causes thermal changes in small intestine meridian pathway. Lasers Med Sci. 2016 Nov;31(8):1645-1649. doi: 10.1007/s10103-016-2032-6. Epub 2016 Aug 5.

    PMID: 27495129BACKGROUND
  • Yang H, Park H, Lim C, Park S, Lee K. Infrared thermal imaging in patients with medial collateral ligament injury of the knee - a retrospective study. J Pharmacopuncture. 2014 Dec;17(4):50-4. doi: 10.3831/KPI.2014.17.036.

    PMID: 25780719BACKGROUND
  • Zheng J, Zhao Y, Wang Y, Hu S, Lu P, Shen X. The infrared radiation temperature characteristic of acupoints of mammary gland hyperplasia patients. Evid Based Complement Alternat Med. 2013;2013:567987. doi: 10.1155/2013/567987. Epub 2013 Nov 14.

    PMID: 24327822BACKGROUND
  • Kang J, Lee N, Ahn Y, Lee H. Study on improving blood flow with Korean red ginseng substances using digital infrared thermal imaging and Doppler sonography: randomized, double blind, placebo-controlled clinical trial with parallel design. J Tradit Chin Med. 2013 Feb;33(1):39-45. doi: 10.1016/s0254-6272(13)60098-9.

    PMID: 23596810BACKGROUND
  • Li X, Jiang Y, Hu H, Zhang Y, Lou J, He X, Sun J, Wu Y, Fang J, Shao X, Fang J. The difference in heat transport characteristics of the heart and lung meridians: A comparative study of COPD patients and healthy subjects. Medicine (Baltimore). 2021 Feb 5;100(5):e23804. doi: 10.1097/MD.0000000000023804.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Jianqiao Fang, Ph.D

    Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongliang Jiang, Ph.D

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 6, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations