Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea
NCT ID: NCT02660970
Last Updated: 2020-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2016-01-31
2020-09-16
Brief Summary
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The majority of children suffering from functional nausea in Europe are treated with Iberogast®. a herbal mixture, whose effect was demonstrated in several studies. Since Iberogast® is not available in the United States of America, children there receive an acupressure therapy. The American gastroenterologists refer hereby to several studies, which have shown, that the positive effect of such therapies in patients with chemotherapy-induced nausea is even greater than a therapy with ondansetron. Since acupressure is able to reduce somatic nausea, it is also believed to decrease functional nausea, but it has never been investigated. Therefore, there are no data. That's why Investigators want to compare the efficacy of these two therapies, that is, Iberogast® and acupressure
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Detailed Description
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However, the majority of children suffering from functional Nausea in Europe get treated with Iberogast®: A herbal mixture, whose effect was demonstrated in several studies \[10, 11\]. Since Iberogast® is not available in the United States of America, children receive there an acupressure therapy. The American gastroenterologists refer hereby to several studies, which have shown, that the effect of such therapies in patient with chemotherapy-induced nausea is even greater than the taking of ondansetron \[12,13 \]. Since acupressure is capable to reduce somatic nausea, it is also believed to decrease functional nausea, but it has never been investigated, therefore no data are available. That's why Investigators plan to compare the efficiency of these two therapies.
Furthermore Investigators want to measure the cognitive performance before and after the intervention to proof a possible effect on the 'gut-brain-axis'. For this purpose the participants have to do the 'Flanker Task', a standardised test on the computer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acupressure
Children will have to wear a 'seasickness-band', which has the effect of acupressure
Acupressure
Children will have to wear a 'seasickness-band', which has the effect of acupressure
Placebo-band
Children will have to wear a 'placebo-wristband'
Placebo-band
Children will have to wear a 'placebo-wristband'
Iberogast
Children will have to take Iberogast drops
Iberogast
Children will have to take Iberogast drops
Placebo-drops
Children will have to take placebo-drops
Placebo-drops
Children will have to take placebo-drops
Interventions
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Acupressure
Children will have to wear a 'seasickness-band', which has the effect of acupressure
Placebo-band
Children will have to wear a 'placebo-wristband'
Iberogast
Children will have to take Iberogast drops
Placebo-drops
Children will have to take placebo-drops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known chronic gastrointestinal disease
* Use of drugs 2 weeks prior to starting the study
6 Years
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Raoul Furlano, MD, Dr
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital
Locations
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Department of Pedriatric Gastroenterology, University Children's Hospital Basel
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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EKNZ 2015-322
Identifier Type: -
Identifier Source: org_study_id
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