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Stimulation of Gastric Slow Waves With Acupuncture at St36 and Pe6 - a Randomized Single-blind Controlled Trial (GSW)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636012
First Posted: March 14, 2008
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
  Purpose
Aim of the study is to investigate specific effects of acupuncture points.

Condition Intervention
Acupuncture Procedure: verum acupuncture Procedure: sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by Claudia M. Witt, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group [ Time Frame: baseline, acupuncture ]

Secondary Outcome Measures:
  • increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation [ Time Frame: baseline, acupuncture ]
  • half cycles [ Time Frame: baseline, acupuncture ]
  • systolic blood pressure [ Time Frame: baseline, acupuncture ]
  • diastolic blood pressure [ Time Frame: baseline, acupuncture ]
  • mean blood pressure [ Time Frame: baseline, acupuncture ]
  • variability of heart rate [ Time Frame: baseline, acupuncture ]
  • heart rate [ Time Frame: baseline, acupuncture ]
  • breathing rate [ Time Frame: baseline, acupuncture ]
  • skin conductance level [ Time Frame: baseline, acupuncture ]
  • total vascular resistance [ Time Frame: baseline, acupuncture ]
  • stroke volume [ Time Frame: baseline, acupuncture ]
  • correlation between percentage of regular gastric slow waves and secondary outcome measures [ Time Frame: baseline, acupuncture ]
  • impact of needle sensation on gastric slow waves [ Time Frame: baseline, acupuncture ]
  • impact of expectation on gastric slow waves [ Time Frame: baseline, acupuncture ]
  • impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves [ Time Frame: baseline, acupuncture ]

Enrollment: 65
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
verum acupuncture
Procedure: verum acupuncture
acupuncture at St36 and Pe6
Sham Comparator: 2
sham acupuncture
Procedure: sham acupuncture
superficial needling at sham points

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • BMI between 17.5 and 25
  • 3 hours before the experiment no food
  • 3 hours before the experiment only water, and 1 hour before the experiment no fluid intake
  • 4 hours before the experiment no smoking
  • informed consent

Exclusion Criteria:

  • acupuncture treatment during the last 12 months
  • chronic disease
  • regular intake of medication which influence autonomic nervous system or GI tract
  • pregnant or breast feeding
  • drug or substance abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636012


Locations
Germany
Charité University Medical Center
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia M. Witt, MD Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
Principal Investigator: Frank Zimmermann-Viehoff, MD Department Psychosomatics and Psychotherapy, Charité University Medical Center, Berlin, Germany
  More Information

Publications:
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00636012     History of Changes
Other Study ID Numbers: GSW-08
First Submitted: March 11, 2008
First Posted: March 14, 2008
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Claudia M. Witt, Charite University, Berlin, Germany:
acupuncture
Acupuncture points