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

Not Applicable

Completed

• Conditions: Acupuncture
• Interventions: Procedure: verum acupuncture; Procedure: sham acupuncture

• Registration Number: NCT00636012
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-14
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	verum acupuncture	verum acupuncture
2	sham acupuncture	sham acupuncture

Primary Outcome Measures

Name	Time	Method
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group	baseline, acupuncture

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité University Medical Center; 🇩🇪 Berlin, Germany