A Study on the Metabolic Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Stable Angina Pectoris
NCT ID: NCT04041245
Last Updated: 2019-08-06
Study Results
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Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2019-06-01
2021-12-31
Brief Summary
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Detailed Description
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Primary outcomes will be regional oxygen saturation (rSO2). Furthermore, this study will build standardized techniques and schemes for detecting the metabolic characteristics of meridian phenomenon for Heart and Lung. The results of this study could also provide scientific foundation for traditional meridian theories.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CSAP group
This group will include 40 patients with chronic stable angina pectoris (CSAP).
Near infrared spectroscopy
Near infrared spectroscopy will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.
1. Experimental device: a four-channel INVOS 5100C Oximeter (Somanetics Corp., Troy, USA)
2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination.
They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. After ripping the transparent adhesive tape on the probe, the probes will be left at 4 measuring sites. Regional oxygen saturation (rSO2) will be recorded for 5 minutes.
3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.
Healthy group
This group will include 40 healthy volunteers.
Near infrared spectroscopy
Near infrared spectroscopy will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.
1. Experimental device: a four-channel INVOS 5100C Oximeter (Somanetics Corp., Troy, USA)
2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination.
They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. After ripping the transparent adhesive tape on the probe, the probes will be left at 4 measuring sites. Regional oxygen saturation (rSO2) will be recorded for 5 minutes.
3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.
Interventions
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Near infrared spectroscopy
Near infrared spectroscopy will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.
1. Experimental device: a four-channel INVOS 5100C Oximeter (Somanetics Corp., Troy, USA)
2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination.
They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. After ripping the transparent adhesive tape on the probe, the probes will be left at 4 measuring sites. Regional oxygen saturation (rSO2) will be recorded for 5 minutes.
3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.
Eligibility Criteria
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Inclusion Criteria
2. Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
3. The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
4. 35 ≤ age ≤65 years, male or female;
5. Patients have clear consciousness and could communicate with others normally;
6. Patients could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin.
1. Healthy volunteers who could provide a recent (in the past 3 month) medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
2. 35 ≤ age ≤65 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
2. Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
3. Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
4. Patients have concomitant conditions of lung diseases, such as COPD;
5. Patients have serious concomitant conditions and and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological and nervous system;
6. Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;
7. Pregnant or lactating patients;
8. Patients are participating in other trials.
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.
35 Years
65 Years
ALL
No
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
The First Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
Zhejiang Chinese Medical University
OTHER_GOV
Responsible Party
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Jianqiao Fang
President
Principal Investigators
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Jianqiao Fang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Chinese Medical University
Locations
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the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2019ZY002-MERIDIAN
Identifier Type: -
Identifier Source: org_study_id
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