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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00636012
First received: March 11, 2008
Last updated: July 9, 2012
Last verified: July 2012
  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 Blind (Subject)
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 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 11, 2008
Last Updated: July 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
acupuncture
Acupuncture points

ClinicalTrials.gov processed this record on October 29, 2014