Difference in the Metabolic Characteristics of COPD Patients and Healthy Adults
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Jan 2020
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2019
CompletedFirst Posted
Study publicly available on registry
August 6, 2019
CompletedStudy Start
First participant enrolled
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJune 16, 2020
June 1, 2020
11 months
August 2, 2019
June 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
COPD group
OTHERThis group will include 40 patients with chronic obstructive pulmonary disease (COPD).
Healthy group
OTHERThis group will include 40 healthy volunteers.
Healthy intervention group
OTHERThis group will include 40 healthy volunteers, who will receive moxibustion intervention.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
- ≤ 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;
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, 310000, China
Related Publications (12)
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PMID: 10975151BACKGROUNDRaith 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.
PMID: 23762122BACKGROUNDLitscher 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.
PMID: 12051136BACKGROUNDTakamoto 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.
PMID: 20502956BACKGROUNDLitscher 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.
PMID: 16137980BACKGROUNDLitscher 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.
PMID: 9584920BACKGROUNDOhkubo 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.
PMID: 19291290BACKGROUNDLitscher 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.
PMID: 23476689BACKGROUNDBanzer 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.
PMID: 17069486BACKGROUNDJimbo 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.
PMID: 18392913BACKGROUNDMurkin 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.
PMID: 20007987BACKGROUNDJiang 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.
PMID: 32791715DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianqiao Fang, Ph.D
Zhejiang Chinese Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
August 2, 2019
First Posted
August 6, 2019
Study Start
January 3, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share