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

Acupuncture Clinical Trial

— GSW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636012
• Other study ID #: GSW-08
• Status: Completed
• Phase: N/A
• First received: March 11, 2008
• Last updated: July 9, 2012
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Acupuncture

Intervention

Procedure:
• verum acupuncture
acupuncture at St36 and Pe6
• sham acupuncture
superficial needling at sham points

Locations

Country	Name	City	State
Germany	Charité University Medical Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Witt CM, Meissner K, Pach D, Thiele C, Lüdtke R, Ghadiyali Z, Deter HC, Zimmermann-Viehoff F. Stimulation of gastric slow waves with manual acupuncture at acupuncture points ST36 and PC6--a randomized single blind controlled trial. Neurogastroenterol Moti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group		baseline, acupuncture	No
Secondary	increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation		baseline, acupuncture	No
Secondary	half cycles		baseline, acupuncture	No
Secondary	systolic blood pressure		baseline, acupuncture	No
Secondary	diastolic blood pressure		baseline, acupuncture	No
Secondary	mean blood pressure		baseline, acupuncture	No
Secondary	variability of heart rate		baseline, acupuncture	No
Secondary	heart rate		baseline, acupuncture	No
Secondary	breathing rate		baseline, acupuncture	No
Secondary	skin conductance level		baseline, acupuncture	No
Secondary	total vascular resistance		baseline, acupuncture	No
Secondary	stroke volume		baseline, acupuncture	No
Secondary	correlation between percentage of regular gastric slow waves and secondary outcome measures		baseline, acupuncture	No
Secondary	impact of needle sensation on gastric slow waves		baseline, acupuncture	No
Secondary	impact of expectation on gastric slow waves		baseline, acupuncture	No
Secondary	impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves		baseline, acupuncture	No