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Status unknownNCT04046666Updated Jun 16, 2020

Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults

An interventional study of Functional near infrared spectroscopy and Moxibustion in Chronic Obstructive Pulmonary Disease, sponsored by Zhejiang Chinese Medical University. Status unknown at 1 site in China. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Zhejiang Chinese Medical University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
35 Years to 75 Years
Sex
All
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Study 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.

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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • meridians
  • acupuncture
  • chronic obstructive pulmonary disease
  • meridian phenomenon
  • near infrared spectroscopy
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 120 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Zhejiang Chinese Medical University is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    COPD group

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

    Device: Functional near infrared spectroscopy

  • Other
    Healthy group

    This group will include 40 healthy volunteers.

    Device: Functional near infrared spectroscopy

  • Other
    Healthy intervention group

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

    Device: Functional near infrared spectroscopy · Procedure: Moxibustion

Interventions

  • DeviceFunctional 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.

  • ProcedureMoxibustion

    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.

06

What researchers measure

Primary outcomes

  1. Change from baseline regional oxygen saturation (rSO2)

    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

07

Study locations

1 of 1 sites recruiting
  • the Third affiliated hospital of Zhejiang Chinese Medical university
    Hanzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

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 10975151 ↗
  • Raith 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 23762122 ↗
  • Litscher 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 12051136 ↗
  • Takamoto 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 20502956 ↗
  • Litscher 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 16137980 ↗
  • Litscher 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 9584920 ↗
  • Ohkubo 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 19291290 ↗
  • Litscher 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 23476689 ↗
  • Banzer 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 17069486 ↗
  • Jimbo 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 18392913 ↗
  • Murkin 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 20007987 ↗
  • Jiang 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04046666
Lead sponsor
Zhejiang Chinese Medical University
Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University
Responsible party
Jianqiao Fang (President, Zhejiang Chinese Medical University) — Principal investigator
First posted
Aug 6, 2019
Start date
Jan 3, 2020
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jun 16, 2020

Study contacts

Yongliang Jiang, Ph.D
Contact
jyl2182@126.com
86-13858173136
Hantong Hu
Contact
413351308@qq.com
86-18667103032
Jianqiao Fang, Ph.D
principal investigator · Zhejiang Chinese Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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