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Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Functional near infrared spectroscopy
Moxibustion
Sponsored by
Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, near infrared spectroscopy

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • the Third affiliated hospital of Zhejiang Chinese Medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

COPD group

Healthy group

Healthy intervention group

Arm Description

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

This group will include 40 healthy volunteers.

This group will include 40 healthy volunteers, who will receive moxibustion intervention.

Outcomes

Primary Outcome Measures

Change from baseline regional oxygen saturation (rSO2)
Regional oxygen saturation could reflect the metabolic characteristics of meridians.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2019
Last Updated
June 12, 2020
Sponsor
Zhejiang Chinese Medical University
Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04046666
Brief Title
Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults
Official Title
Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Chinese Medical University
Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, near infrared spectroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD group
Arm Type
Other
Arm Description
This group will include 40 patients with chronic obstructive pulmonary disease (COPD).
Arm Title
Healthy group
Arm Type
Other
Arm Description
This group will include 40 healthy volunteers.
Arm Title
Healthy intervention group
Arm Type
Other
Arm Description
This group will include 40 healthy volunteers, who will receive moxibustion intervention.
Intervention Type
Device
Intervention Name(s)
Functional near infrared spectroscopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Moxibustion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline regional oxygen saturation (rSO2)
Description
Regional oxygen saturation could reflect the metabolic characteristics of meridians.
Time Frame
5-minute baseline, 15 minutes during moxibustion and 5 minutes after removal of moxibustion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for COPD 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; 35 ≤ 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 by themselves or their lineal kin. Inclusion criteria for health volunteers 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 have high adherence .Written informed consent is signed by themselves or their lineal kin. Exclusion Criteria: Exclusion criteria for COPD 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; 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. Exclusion criteria of health volunteers 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongliang Jiang, Ph.D
Phone
86-13858173136
Email
jyl2182@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hantong Hu
Phone
86-18667103032
Email
413351308@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianqiao Fang, Ph.D
Organizational Affiliation
Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third affiliated hospital of Zhejiang Chinese Medical university
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hantong Hu
Phone
86-18667103032
Email
413351308@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaoyu Li
Phone
86-15017541803
Email
752616172@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults

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