Stimulation of Gastric Slow Waves With Acupuncture at St36 and Pe6 - a Randomized Single-blind Controlled Trial
GSW
1 other identifier
interventional
65
1 country
1
Brief Summary
Aim of the study is to investigate specific effects of acupuncture points.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 11, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedJuly 10, 2012
July 1, 2012
2 months
March 11, 2008
July 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group
baseline, acupuncture
Secondary Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALverum acupuncture
2
SHAM COMPARATORsham acupuncture
Interventions
Eligibility Criteria
You may qualify if:
- healthy volunteers
- BMI between 17.5 and 25
- hours before the experiment no food
- hours before the experiment only water, and 1 hour before the experiment no fluid intake
- hours before the experiment no smoking
- informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité University Medical Center
Berlin, Germany
Related Publications (1)
Witt CM, Meissner K, Pach D, Thiele C, Ludtke 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 Motil. 2012 May;24(5):438-45, e211-2. doi: 10.1111/j.1365-2982.2012.01877.x. Epub 2012 Feb 6.
PMID: 22309404RESULT
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
March 11, 2008
First Posted
March 14, 2008
Study Start
March 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
July 10, 2012
Record last verified: 2012-07