NCT00636012CompletedNot Applicable
Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial
Charite University, Berlin, Germany1 site in 1 country65 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group
Study Overview
Brief Summary
Aim of the study is to investigate specific effects of acupuncture points.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
2
Sham Comparator
sham acupuncture
Intervention: sham acupuncture (Procedure)
1
Experimental
verum acupuncture
Intervention: verum acupuncture (Procedure)
Outcomes
Primary Outcomes
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group
Time Frame: baseline, acupuncture
Secondary Outcomes
- 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)
Investigators
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication AdherenceHIV InfectionsNCT00545623Boston University130
Completed
Not Applicable
Effect of Acupressure on Interventional Pain in InfantsChild, OnlyProcedural PainNCT05166551Istanbul University - Cerrahpasa (IUC)105
Completed
Not Applicable
Acute Effects of Acupuncture in the Response of the Median Neurodynamic TestOther Lesions of Median NerveNCT02150915Nuno Morais32
Completed
Not Applicable
Local Effects of Acupuncture and Nerve Conduction StudiesCarpal Tunnel SyndromeNCT03036657Oregon Health and Science University60
Recruiting
Phase 3
The effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN).Diabetes-related peripheral neuropathy (DPN)..Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecifiedE08.40IRCT20181006041252N13Sabzevar University of Medical Sciences50