Chronic Obstructive Pulmonary DiseaseNCT04046666
Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults
A study testing Functional near infrared spectroscopy and Moxibustion in people with Chronic Obstructive Pulmonary Disease, run by Zhejiang Chinese Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Functional near infrared spectroscopy and Moxibustion
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2020to Dec 2021
- Phase
- Interventional
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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;
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- 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.
Who cannot join
- 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;
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- Patients are participating in other trials.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, 310000
Hantong Hu, 86-18667103032, 413351308@qq.com
Xiaoyu Li, 86-15017541803, 752616172@qq.com
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Functional near infrared spectroscopy, Moxibustion
- Keywords
- meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, near infrared spectroscopy
- 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.
Functional near infrared spectroscopyDevice
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.
MoxibustionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| COPD group | Other | This group will include 40 patients with chronic obstructive pulmonary disease (COPD). Receives: Device: Functional near infrared spectroscopy |
| Healthy group | Other | This group will include 40 healthy volunteers. Receives: Device: Functional near infrared spectroscopy |
| Healthy intervention group | Other | This group will include 40 healthy volunteers, who will receive moxibustion intervention. Receives: Device: Functional near infrared spectroscopy; Procedure: Moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline regional oxygen saturation (rSO2)
Regional oxygen saturation could reflect the metabolic characteristics of meridians.
Measured: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after removal of moxibustion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start3 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Responsible party
- Principal investigator, Jianqiao Fang, Zhejiang Chinese Medical University
- Investigators
- Jianqiao Fang, Ph.D, Principal investigator, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046666
- Sponsor's protocol ID
- 2019ZY005-MERIDIAN
- Status last verified
- Jun 2020
- First submitted
- 2 Aug 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Litscher G, Wang L. [Cerebral near infrared spectroscopy and acupuncture--results of a pilot study]. Biomed Tech (Berl). 2000 Jul-Aug;45(7-8):215-8. doi: 10.1515/bmte.2000.45.7-8.215. German.
PubMed 10975151Raith W, Pichler G, Sapetschnig I, Avian A, Sommer C, Baik N, Koestenberger M, Schmolzer 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.
PubMed 23762122Litscher G, Wang L, Huber E. [Changes in cerebral near infrared spectroscopy parameters during manual acupuncture needle stimulation]. Biomed Tech (Berl). 2002 Apr;47(4):76-9. doi: 10.1515/bmte.2002.47.4.76. German.
PubMed 12051136Takamoto K, Hori E, Urakawa S, Sakai S, Ishikawa A, Kohno S, Ono T, Nishijo H. Cerebral hemodynamic responses induced by specific acupuncture sensations during needling at trigger points: a near-infrared spectroscopic study. Brain Topogr. 2010 Sep;23(3):279-91. doi: 10.1007/s10548-010-0148-8. Epub 2010 May 26.
PubMed 20502956Litscher G, Wang L, Schwarz G, Schikora D. [Increases of intracranial pressure and changes of blood flow velocity due to acupressure, needle and laser needle acupuncture?]. Forsch Komplementarmed Klass Naturheilkd. 2005 Aug;12(4):190-5. doi: 10.1159/000087044. Epub 2005 Aug 29. German.
PubMed 16137980Litscher G, Schwarz G, Sandner-Kiesling A, Hadolt I, Eger E. Effects of acupuncture on the oxygenation of cerebral tissue. Neurol Res. 1998;20 Suppl 1:S28-32. doi: 10.1080/01616412.1998.11740605.
PubMed 9584920Ohkubo M, Hamaoka T, Niwayama M, Murase N, Osada T, Kime R, Kurosawa Y, Sakamoto A, Katsumura T. Local increase in trapezius muscle oxygenation during and after acupuncture. Dyn Med. 2009 Mar 16;8:2. doi: 10.1186/1476-5918-8-2.
PubMed 19291290Litscher G, Ofner M, He W, Wang L, Gaischek I. Acupressure at the Meridian Acupoint Xiyangguan (GB33) Influences Near-Infrared Spectroscopic Parameters (Regional Oxygen Saturation) in Deeper Tissue of the Knee in Healthy Volunteers. Evid Based Complement Alternat Med. 2013;2013:370341. doi: 10.1155/2013/370341. Epub 2013 Feb 7.
PubMed 23476689Banzer W, Hubscher M, Seib M, Vogt L. Short-time effects of laser needle stimulation on the peripheral microcirculation assessed by laser Doppler spectroscopy and near-infrared spectroscopy. Photomed Laser Surg. 2006 Oct;24(5):575-80. doi: 10.1089/pho.2006.24.575.
PubMed 17069486Jimbo S, Atsuta Y, Kobayashi T, Matsuno T. Effects of dry needling at tender points for neck pain (Japanese: katakori): near-infrared spectroscopy for monitoring muscular oxygenation of the trapezius. J Orthop Sci. 2008 Mar;13(2):101-6. doi: 10.1007/s00776-007-1209-z. Epub 2008 Apr 8.
PubMed 18392913Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
PubMed 20007987Jiang Y, Hu H, Li X, He X, Shao X, Lou J, Zhang Y, Wu Y, Fang J. Difference in the metabolic characteristics of chronic obstructive pulmonary disease patients and healthy adults. Medicine (Baltimore). 2020 Jul 24;99(30):e21302. doi: 10.1097/MD.0000000000021302.
PubMed 32791715
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults
- ClinicalTrials.gov ID
- NCT04046666
- Acronym / sponsor ID
- 2019ZY005-MERIDIAN
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- meridians, acupuncture, chronic obstructive pulmonary disease, meridian phenomenon, near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Aug 2019 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD group | Other | Device: Functional near infrared spectroscopyThis group will include 40 patients with chronic obstructive pulmonary disease (COPD). |
| Healthy group | Other | Device: Functional near infrared spectroscopyThis group will include 40 healthy volunteers. |
| Healthy intervention group | Other | Device: Functional near infrared spectroscopy, Procedure: MoxibustionThis group will include 40 healthy volunteers, who will receive moxibustion intervention. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional near infrared spectroscopyFunctional 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. | Device | COPD group, Healthy group, Healthy intervention group |
| MoxibustionTwo 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. | Procedure or surgery | Healthy intervention group |
Primary outcome
Change from baseline regional oxygen saturation (rSO2)
Time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after removal of moxibustion
Regional oxygen saturation could reflect the metabolic characteristics of meridians.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 10975151Litscher G, Wang L. [Cerebral near infrared spectroscopy and acupuncture--results of a pilot study]. Biomed Tech (Berl). 2000 Jul-Aug;45(7-8):215-8. doi: 10.1515/bmte.2000.45.7-8.215. German.
- Background: PubMed 23762122Raith W, Pichler G, Sapetschnig I, Avian A, Sommer C, Baik N, Koestenberger M, Schmolzer 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.
- Background: PubMed 12051136Litscher G, Wang L, Huber E. [Changes in cerebral near infrared spectroscopy parameters during manual acupuncture needle stimulation]. Biomed Tech (Berl). 2002 Apr;47(4):76-9. doi: 10.1515/bmte.2002.47.4.76. German.
- Background: PubMed 20502956Takamoto K, Hori E, Urakawa S, Sakai S, Ishikawa A, Kohno S, Ono T, Nishijo H. Cerebral hemodynamic responses induced by specific acupuncture sensations during needling at trigger points: a near-infrared spectroscopic study. Brain Topogr. 2010 Sep;23(3):279-91. doi: 10.1007/s10548-010-0148-8. Epub 2010 May 26.
- Background: PubMed 16137980Litscher G, Wang L, Schwarz G, Schikora D. [Increases of intracranial pressure and changes of blood flow velocity due to acupressure, needle and laser needle acupuncture?]. Forsch Komplementarmed Klass Naturheilkd. 2005 Aug;12(4):190-5. doi: 10.1159/000087044. Epub 2005 Aug 29. German.
- Background: PubMed 9584920Litscher G, Schwarz G, Sandner-Kiesling A, Hadolt I, Eger E. Effects of acupuncture on the oxygenation of cerebral tissue. Neurol Res. 1998;20 Suppl 1:S28-32. doi: 10.1080/01616412.1998.11740605.
- Background: PubMed 19291290Ohkubo M, Hamaoka T, Niwayama M, Murase N, Osada T, Kime R, Kurosawa Y, Sakamoto A, Katsumura T. Local increase in trapezius muscle oxygenation during and after acupuncture. Dyn Med. 2009 Mar 16;8:2. doi: 10.1186/1476-5918-8-2.
- Background: PubMed 23476689Litscher G, Ofner M, He W, Wang L, Gaischek I. Acupressure at the Meridian Acupoint Xiyangguan (GB33) Influences Near-Infrared Spectroscopic Parameters (Regional Oxygen Saturation) in Deeper Tissue of the Knee in Healthy Volunteers. Evid Based Complement Alternat Med. 2013;2013:370341. doi: 10.1155/2013/370341. Epub 2013 Feb 7.
- Background: PubMed 17069486Banzer W, Hubscher M, Seib M, Vogt L. Short-time effects of laser needle stimulation on the peripheral microcirculation assessed by laser Doppler spectroscopy and near-infrared spectroscopy. Photomed Laser Surg. 2006 Oct;24(5):575-80. doi: 10.1089/pho.2006.24.575.
- Background: PubMed 18392913Jimbo S, Atsuta Y, Kobayashi T, Matsuno T. Effects of dry needling at tender points for neck pain (Japanese: katakori): near-infrared spectroscopy for monitoring muscular oxygenation of the trapezius. J Orthop Sci. 2008 Mar;13(2):101-6. doi: 10.1007/s00776-007-1209-z. Epub 2008 Apr 8.
- Background: PubMed 20007987Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
- Derived from this study: PubMed 32791715Jiang Y, Hu H, Li X, He X, Shao X, Lou J, Zhang Y, Wu Y, Fang J. Difference in the metabolic characteristics of chronic obstructive pulmonary disease patients and healthy adults. Medicine (Baltimore). 2020 Jul 24;99(30):e21302. doi: 10.1097/MD.0000000000021302.
- 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
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?
A study testing Functional near infrared spectroscopy and Moxibustion in people with Chronic Obstructive Pulmonary Disease, run by 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongliang Jiang, Ph.D (86-13858173136, jyl2182@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline regional oxygen saturation (rSO2) (time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after removal of moxibustion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046666, which also lists 12 linked publications.
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 16 Jun 2020.