AcupunctureGSWNCT00636012
Stimulation of Gastric Slow Waves With Acupuncture at St36 and Pe6 - a Randomized Single-blind Controlled Trial
A study testing verum acupuncture in people with Acupuncture, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Aim of the study is to investigate specific effects of acupuncture points. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture
- What is being tested?
- verum acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial
Aim of the study is to investigate specific effects of acupuncture points.
- Conditions
- Acupuncture
- Being tested
- verum acupuncture, sham acupuncture
- Keywords
- acupuncture, Acupuncture points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verum acupunctureProcedure or surgery
acupuncture at St36 and Pe6
sham acupunctureProcedure or surgery
superficial needling at sham points
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | verum acupuncture Receives: Procedure: verum acupuncture |
| 2 | Sham comparator | sham acupuncture Receives: Procedure: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group
Measured: baseline, acupuncture
Secondary outcomes (15)
increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation
Measured: baseline, acupuncture
half cycles
Measured: baseline, acupuncture
systolic blood pressure
Measured: baseline, acupuncture
diastolic blood pressure
Measured: baseline, acupuncture
mean blood pressure
Measured: baseline, acupuncture
variability of heart rate
Measured: baseline, acupuncture
heart rate
Measured: baseline, acupuncture
breathing rate
Measured: baseline, acupuncture
skin conductance level
Measured: baseline, acupuncture
total vascular resistance
Measured: baseline, acupuncture
stroke volume
Measured: baseline, acupuncture
correlation between percentage of regular gastric slow waves and secondary outcome measures
Measured: baseline, acupuncture
impact of needle sensation on gastric slow waves
Measured: baseline, acupuncture
impact of expectation on gastric slow waves
Measured: baseline, acupuncture
impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves
Measured: baseline, acupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M. Witt, MD, Principal investigator, Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, GermanyFrank Zimmermann-Viehoff, MD, Principal investigator, Department Psychosomatics and Psychotherapy, Charité University Medical Center, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636012
- Sponsor's protocol ID
- GSW-08
- Acronym
- GSW
- Status last verified
- Jul 2012
- First submitted
- 11 Mar 2008
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22309404
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT00636012
- Acronym / sponsor ID
- GSW / GSW-08
- Conditions
- Acupuncture
- Keywords
- acupuncture, Acupuncture points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to investigate specific effects of acupuncture points.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: verum acupunctureverum acupuncture |
| 2 | Sham comparator | Procedure: sham acupuncturesham acupuncture |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| verum acupunctureacupuncture at St36 and Pe6 | Procedure or surgery | 1 |
| sham acupuncturesuperficial needling at sham points | Procedure or surgery | 2 |
Primary outcome
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group
Time frame: baseline, acupuncture
15 secondary outcomes
increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation
Time frame: baseline, acupuncture
half cycles
Time frame: baseline, acupuncture
systolic blood pressure
Time frame: baseline, acupuncture
diastolic blood pressure
Time frame: baseline, acupuncture
mean blood pressure
Time frame: baseline, acupuncture
variability of heart rate
Time frame: baseline, acupuncture
heart rate
Time frame: baseline, acupuncture
breathing rate
Time frame: baseline, acupuncture
skin conductance level
Time frame: baseline, acupuncture
total vascular resistance
Time frame: baseline, acupuncture
stroke volume
Time frame: baseline, acupuncture
correlation between percentage of regular gastric slow waves and secondary outcome measures
Time frame: baseline, acupuncture
impact of needle sensation on gastric slow waves
Time frame: baseline, acupuncture
impact of expectation on gastric slow waves
Time frame: baseline, acupuncture
impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves
Time frame: baseline, acupuncture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Results publication: PubMed 22309404Witt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia M. Witt, MD principal investigator
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
Frank Zimmermann-Viehoff, MD principal investigator
Department Psychosomatics and Psychotherapy, Charité University Medical Center, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verum acupuncture in people with Acupuncture, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group (time frame: baseline, acupuncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.