Chronic Obstructive Pulmonary DiseaseNCT05690217
The Difference in the Biological Characteristic Characteristics of the Heart and Lung Meridians
An observational study of Chronic Obstructive Pulmonary Disease, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
The association between viscera and the body surface remains obscure, but a better understanding of it will maximize its diagnostic and therapeutic values in clinical practice. Therefore, this study aimed to investigate the specificity of the association between viscera and the body surface in the pathological state. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: The diagnostic criteria of COPD were based on criteria proposed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) consensus published in 2017, in which persistent airflow obstruction is confirmed according to the pulmonary function test. Healthy participants were determined by a medical examination report within 6 preceding months for confirming their health conditions.
Who may be able to join
- COPD participants were eligible if they 1) satisfied the diagnostic criteria of COPD; 2) were in the stable phase of COPD; 3) were 20 ≤ age ≤ 75 years; 4) fully understood the study protocol and signed the written informed consent. Healthy participants were eligible if they 1) were healthy subjects who provided a medical examination report within 6 preceding months for confirming their health conditions; 2) were age-matched with the COPD group; 3) fully understood the study protocol and signed the written informed consent.
Who cannot join
- COPD patients were excluded if they 1) had other major lung diseases, such as bronchiectasis, pneumothorax, and lung tumors; 2) had concomitant heart diseases; 3) had serious concomitant diseases in major systems that were not controlled effectively 4) had mental diseases, history of drug abuse, and alcohol dependence; 5) were lactating or pregnant and 6)had scarring, hyperpigmentation, redness, swelling and heat in the skin around the measurement sites, which would affect the accuracy of examinations. Healthy subjects were excluded if they 1) had mental illness, history of drug abuse and alcohol dependence; 2) were lactating or pregnant; 3) had scarring, hyperpigmentation, redness, swelling, and heat in the skin around the measurement sites, which would affect the accuracy of examinations.
Trial locations and contacts
1 site in 1 country.
China1 site
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
About this study
Official title: The Difference in the Biological Characteristic Characteristics of the Heart and Lung Meridians Between COPD Patients and Healthy Subjects
The association between viscera and the body surface remains obscure, but a better understanding of it will maximize its diagnostic and therapeutic values in clinical practice. Therefore, this study aimed to investigate the specificity of the association between viscera and the body surface in the pathological state.
Read the detailed description
Study subjects included 40 chronic obstructive pulmonary disease (COPD) participants in the COPD group and 40 age-matched healthy participants in the healthy control group. Laser doppler flowmetry, infrared thermography, and functional near-infrared spectroscopy were respectively adopted to measure (1) the perfusion unit (PU), (2) temperature, and (3) regional oxygen saturation (rSO2) of 4 specific somatic sites distributing in the heart and lung meridians. These 3 outcome measures reflected the microcirculatory, thermal and metabolic characteristics of the body surface, respectively.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- acupuncture, meridians, biological characteristic
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD group | There are 40 chronic obstructive pulmonary disease (COPD) patients in the COPD group. | |
| Healthy control group | There are 40 age-matched healthy participants in the healthy control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion unit
Perfusion unit of acupuncture points is measured by Laser doppler flowmetry
Measured: Baseline
Temperature
Temperature of acupuncture points is measured by infrared thermography
Measured: Baseline
Regional oxygen saturation
Regional oxygen saturation of acupuncture points is measured by functional near-infrared spectroscopy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hantong Hu, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Jianqiao Fang, Ph.D, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690217
- Sponsor's protocol ID
- ZSLL-KY-2019-001
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference in the Biological Characteristic Characteristics of the Heart and Lung Meridians Between COPD Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT05690217
- Acronym / sponsor ID
- ZSLL-KY-2019-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- acupuncture, meridians, biological characteristic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The association between viscera and the body surface remains obscure, but a better understanding of it will maximize its diagnostic and therapeutic values in clinical practice. Therefore, this study aimed to investigate the specificity of the association between viscera and the body surface in the pathological state.
Detailed description
Study subjects included 40 chronic obstructive pulmonary disease (COPD) participants in the COPD group and 40 age-matched healthy participants in the healthy control group. Laser doppler flowmetry, infrared thermography, and functional near-infrared spectroscopy were respectively adopted to measure (1) the perfusion unit (PU), (2) temperature, and (3) regional oxygen saturation (rSO2) of 4 specific somatic sites distributing in the heart and lung meridians. These 3 outcome measures reflected the microcirculatory, thermal and metabolic characteristics of the body surface, respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | –There are 40 chronic obstructive pulmonary disease (COPD) patients in the COPD group. |
| Healthy control group | – | –There are 40 age-matched healthy participants in the healthy control group. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The diagnostic criteria of COPD were based on criteria proposed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) consensus published in 2017, in which persistent airflow obstruction is confirmed according to the pulmonary function test. Healthy participants were determined by a medical examination report within 6 preceding months for confirming their health conditions.
Key inclusion criteria (1 listed)
- COPD participants were eligible if they 1) satisfied the diagnostic criteria of COPD; 2) were in the stable phase of COPD; 3) were 20 ≤ age ≤ 75 years; 4) fully understood the study protocol and signed the written informed consent. Healthy participants were eligible if they 1) were healthy subjects who provided a medical examination report within 6 preceding months for confirming their health conditions; 2) were age-matched with the COPD group; 3) fully understood the study protocol and signed the written informed consent.
Key exclusion criteria (1 listed)
- COPD patients were excluded if they 1) had other major lung diseases, such as bronchiectasis, pneumothorax, and lung tumors; 2) had concomitant heart diseases; 3) had serious concomitant diseases in major systems that were not controlled effectively 4) had mental diseases, history of drug abuse, and alcohol dependence; 5) were lactating or pregnant and 6)had scarring, hyperpigmentation, redness, swelling and heat in the skin around the measurement sites, which would affect the accuracy of examinations. Healthy subjects were excluded if they 1) had mental illness, history of drug abuse and alcohol dependence; 2) were lactating or pregnant; 3) had scarring, hyperpigmentation, redness, swelling, and heat in the skin around the measurement sites, which would affect the accuracy of examinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perfusion unit
Time frame: Baseline
Perfusion unit of acupuncture points is measured by Laser doppler flowmetry
Temperature
Time frame: Baseline
Temperature of acupuncture points is measured by infrared thermography
Regional oxygen saturation
Time frame: Baseline
Regional oxygen saturation of acupuncture points is measured by functional near-infrared spectroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianqiao Fang, Ph.D principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion unit (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.