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Completed

NCT Number: NCT00636012

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

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

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Key information

Conditions

Acupuncture

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Medical Center

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

verum acupuncture

Procedure

acupuncture at St36 and Pe6

Sham acupuncture

Procedure

superficial needling at sham points

Primary outcomes

  1. increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group

    Time frame: baseline, acupuncture

Secondary outcomes

  1. increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation

    Time frame: baseline, acupuncture

  2. half cycles

    Time frame: baseline, acupuncture

  3. systolic blood pressure

    Time frame: baseline, acupuncture

  4. diastolic blood pressure

    Time frame: baseline, acupuncture

  5. mean blood pressure

    Time frame: baseline, acupuncture

  6. variability of heart rate

    Time frame: baseline, acupuncture

  7. heart rate

    Time frame: baseline, acupuncture

  8. breathing rate

    Time frame: baseline, acupuncture

  9. skin conductance level

    Time frame: baseline, acupuncture

  10. total vascular resistance

    Time frame: baseline, acupuncture

  11. stroke volume

    Time frame: baseline, acupuncture

  12. correlation between percentage of regular gastric slow waves and secondary outcome measures

    Time frame: baseline, acupuncture

  13. impact of needle sensation on gastric slow waves

    Time frame: baseline, acupuncture

  14. impact of expectation on gastric slow waves

    Time frame: baseline, acupuncture

  15. impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves

    Time frame: baseline, acupuncture

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: GSW

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2008
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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