Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046666
• Other study ID #: 2019ZY005-MERIDIAN
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: December 2021

Study information

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

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 meridians are urgently needed. Therefore, this study is designed to assess the metabolic characteristics of the Heart and Lung meridians by using functional near infrared spectroscopy. Thus, the biological characteristics of meridians could be presented objectively in a scientific methodology.

Description:

The Lung and Heart meridians are chosen as two specific studied meridians. Participants of chronic obstructive pulmonary disease (COPD) and healthy volunteers will be enrolled.

120 participants will be included and divided into the healthy control group, chronic obstructive pulmonary disease (COPD) group and healthy intervention group. Functional near infrared spectroscopy will be used to assess the metabolic characteristics of the Heart and Lung meridians. The specificity for the meridian-visceral association will be investigated by comparing the metabolic 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 specificity for the site-to-site association.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for COPD

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 written informed consent is signed by themselves or their lineal kin.

Inclusion criteria for health volunteers

1. 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;

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 COPD

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;

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;

7. 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:
• Functional near infrared spectroscopy
Functional near infrared spectroscopy will be adopted to assess the metabolic characteristics of the Heart and Lung meridians. The probes will be left at 4 measurement sites, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian.

Procedure:
• Moxibustion
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 near infrared spectroscopy will detect the metabolic characteristics of three measuring sites, which include the midpoint of the Heart meridian along the forearm, Chize (LU5) of the Lung meridian, and the midpoint of the Lung meridian along the forearm. Intervention in the Lung meridian: moxibustion will be performed above Chize (LU5) for 15 minutes. During moxibustion, the probes of near infrared spectroscopy will detect the metabolic 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 forearm.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

China, 

References & Publications (11)

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Raith W, Pichler G, Sapetschnig I, Avian A, Sommer C, Baik N, Koestenberger M, Schmölzer GM, Urlesberger B. Near-infrared spectroscopy for objectifying cerebral effects of laser acupuncture in term and preterm neonates. Evid Based Complement Alternat Med. 2013;2013:346852. doi: 10.1155/2013/346852. Epub 2013 May 15. — View Citation

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* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline regional oxygen saturation (rSO2)	Regional oxygen saturation could reflect the metabolic characteristics of meridians.	5-minute baseline, 15 minutes during moxibustion and 5 minutes after removal of moxibustion