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

July 9, 2012 updated by: Claudia M. Witt, Charite University, Berlin, Germany

Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial

Aim of the study is to investigate specific effects of acupuncture points.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 2
sham acupuncture
Procedure: sham acupuncture
superficial needling at sham points
Experimental: 1
verum acupuncture
Procedure: verum acupuncture
acupuncture at St36 and Pe6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group
Time Frame: baseline, acupuncture
baseline, acupuncture

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Frank Zimmermann-Viehoff, MD, Department Psychosomatics and Psychotherapy, Charité University Medical Center, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GSW-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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