Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea
Primary Purpose
Functional Nausea
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Acupressure
Placebo-band
Iberogast
Placebo-drops
Sponsored by
About this trial
This is an interventional treatment trial for Functional Nausea focused on measuring Iberogast, Acupressure, gut-brain-axis
Eligibility Criteria
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
Sites / Locations
- Department of Pedriatric Gastroenterology, University Children's Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Acupressure
Placebo-band
Iberogast
Placebo-drops
Arm Description
Children will have to wear a 'seasickness-band', which has the effect of acupressure
Children will have to wear a 'placebo-wristband'
Children will have to take Iberogast drops
Children will have to take placebo-drops
Outcomes
Primary Outcome Measures
comparison in the levels of nausea as assessed by visual analog scales (VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02660970
First Posted
January 18, 2016
Last Updated
October 5, 2020
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT02660970
Brief Title
Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea
Official Title
Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea - a Randomized Clinical Trial With Sham-conditions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Nausea
Keywords
Iberogast, Acupressure, gut-brain-axis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupressure
Arm Type
Active Comparator
Arm Description
Children will have to wear a 'seasickness-band', which has the effect of acupressure
Arm Title
Placebo-band
Arm Type
Placebo Comparator
Arm Description
Children will have to wear a 'placebo-wristband'
Arm Title
Iberogast
Arm Type
Active Comparator
Arm Description
Children will have to take Iberogast drops
Arm Title
Placebo-drops
Arm Type
Placebo Comparator
Arm Description
Children will have to take placebo-drops
Intervention Type
Other
Intervention Name(s)
Acupressure
Other Intervention Name(s)
Seasickness-Band
Intervention Description
Children will have to wear a 'seasickness-band', which has the effect of acupressure
Intervention Type
Other
Intervention Name(s)
Placebo-band
Intervention Description
Children will have to wear a 'placebo-wristband'
Intervention Type
Drug
Intervention Name(s)
Iberogast
Intervention Description
Children will have to take Iberogast drops
Intervention Type
Other
Intervention Name(s)
Placebo-drops
Intervention Description
Children will have to take placebo-drops
Primary Outcome Measure Information:
Title
comparison in the levels of nausea as assessed by visual analog scales (VAS)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raoul Furlano, MD, Dr
Organizational Affiliation
University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pedriatric Gastroenterology, University Children's Hospital Basel
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea
We'll reach out to this number within 24 hrs