- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02660970
Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea
Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea - a Randomized Clinical Trial With Sham-conditions
Functional gastrointestinal disorders are common disorders that are characterized by persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the GI tract and are not caused by structural or biochemical abnormalities. As a result, medical tests- such as blood tests and endoscopic exams- have essentially normal/negative (non-disease) results. More than 20 functional GI disorders have been identified. They can affect any part of the GI tract. One of the most common functional disorders is nausea and dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating). Any chronic illness, including functional nausea, will affect a person's health-related quality of life (general well-being, ability to carry out everyday activities), additional psychosocial disturbances and amplify the experienced illness.
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Functional gastrointestinal disorders are common disorders that are characterized by persistent and recurring GI symptoms. These occur as a result of abnormal functioning of the GI tract and are not caused by structural or biochemical abnormalities. As a result, medical tests- such as blood tests and endoscopic exams- have essentially normal/negative (non-disease) results. More than 20 functional GI disorders have been identified. They can affect any part of the GI tract. One of the most common functional disorders is nausea and dyspepsia (pain or discomfort in the upper abdominal area, feeling of fullness, bloating). Any chronic illness, including functional nausea, will affect a person's health-related quality of life (general well-being, ability to carry out everyday activities), additional psychosocial disturbances and amplify the experienced illness.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Basel Stadt
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Basel, Basel Stadt, Switzerland, 4031
- Department of Pedriatric Gastroenterology, University Children's Hospital Basel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Functional nausea (normal endoscopy findings)
Exclusion Criteria:
- Gastrointestinal infection less than 2 weeks ago
- Known chronic gastrointestinal disease
- Use of drugs 2 weeks prior to starting the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Acupressure
Children will have to wear a 'seasickness-band', which has the effect of acupressure
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Children will have to wear a 'seasickness-band', which has the effect of acupressure
Other Names:
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Placebo Comparator: Placebo-band
Children will have to wear a 'placebo-wristband'
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Children will have to wear a 'placebo-wristband'
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Active Comparator: Iberogast
Children will have to take Iberogast drops
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Children will have to take Iberogast drops
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Placebo Comparator: Placebo-drops
Children will have to take placebo-drops
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Children will have to take placebo-drops
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
comparison in the levels of nausea as assessed by visual analog scales (VAS)
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Raoul Furlano, MD, Dr, University Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKNZ 2015-322
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Clinical Trials on Functional Nausea
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Medical College of WisconsinAmerican Neurogastroenterology and Motility SocietyCompletedNausea Persistent | Functional Disorder of IntestineUnited States
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Gisela Grotewold ChelimskyTerminatedDyspepsia | Nausea | Irritable Bowel Syndrome | Functional Gastrointestinal Disorders | Vagus Nerve Autonomic DisorderUnited States
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Nordmark Arzneimittel GmbH & Co. KGClinSupport GmbH; MWI Medizinisches Wirtschaftsinstitut GmbH; das forschungsdockCompletedDyspepsia | Nausea | Vomiting | Abdominal Pain | Functional Gastrointestinal Disorders | FlatulenceGermany
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University of North Carolina, Chapel HillNational Institute of Dental and Craniofacial Research (NIDCR)CompletedPost-operative Nausea | Post-operative Vomiting | Nausea PersistentUnited States
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Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
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MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
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GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
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Hoffmann-La RocheCompletedPost-Operative Nausea and VomitingUnited States
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Cairo UniversityUnknownPost Operative Nausea and VomitingEgypt
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Yonsei UniversityCompletedPost Operative Nausea and VomitingKorea, Republic of
Clinical Trials on Acupressure
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Chang-Hua HospitalChina Medical University HospitalUnknownInsomnia | Anxiety | Menopause | Auricular AcupressureTaiwan
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Mersin UniversityRecruiting
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Mersin UniversityCompleted
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Cairo UniversityCompleted
-
China Medical University HospitalNot yet recruiting
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University of MichiganNational Cancer Institute (NCI)CompletedBreast Cancer | Sleepiness | Chronic FatigueUnited States
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University of MichiganCompleted
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Guangdong Provincial Hospital of Traditional Chinese...Completed
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Mersin UniversityRecruitingPain, Postoperative | Anxiety | Hemodynamic InstabilityTurkey