Functional NauseaNCT02660970
Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea
A study testing Acupressure and Iberogast in people with Functional Nausea, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Functional Nausea
- What is being tested?
- Acupressure and Iberogast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to 16 Sep 2020
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Functional nausea (normal endoscopy findings)
Who cannot join
- Gastrointestinal infection less than 2 weeks ago
- Known chronic gastrointestinal disease
- Use of drugs 2 weeks prior to starting the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Pedriatric Gastroenterology, University Children's Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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
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
Read the 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.
- Conditions
- Functional Nausea
- Being tested
- Acupressure, Placebo-band, Iberogast, Placebo-drops
- Keywords
- Iberogast, Acupressure, gut-brain-axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Also called Seasickness-Band
Children will have to wear a 'seasickness-band', which has the effect of acupressure
Placebo-bandOther
Children will have to wear a 'placebo-wristband'
IberogastDrug
Children will have to take Iberogast drops
Placebo-dropsOther
Children will have to take placebo-drops
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Active comparator | Children will have to wear a 'seasickness-band', which has the effect of acupressure Receives: Other: Acupressure |
| Placebo-band | Placebo comparator | Children will have to wear a 'placebo-wristband' Receives: Other: Placebo-band |
| Iberogast | Active comparator | Children will have to take Iberogast drops Receives: Drug: Iberogast |
| Placebo-drops | Placebo comparator | Children will have to take placebo-drops Receives: Other: Placebo-drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison in the levels of nausea as assessed by visual analog scales (VAS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional NauseaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Furlano, MD, Dr, Principal investigator, University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660970
- Sponsor's protocol ID
- EKNZ 2015-322
- Status last verified
- Oct 2020
- First submitted
- 18 Jan 2016
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02660970
- Acronym / sponsor ID
- EKNZ 2015-322
- Conditions
- Functional Nausea
- Keywords
- Iberogast, Acupressure, gut-brain-axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 21 Jan 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Active comparator | Other: AcupressureChildren will have to wear a 'seasickness-band', which has the effect of acupressure |
| Placebo-band | Placebo comparator | Other: Placebo-bandChildren will have to wear a 'placebo-wristband' |
| Iberogast | Active comparator | Drug: IberogastChildren will have to take Iberogast drops |
| Placebo-drops | Placebo comparator | Other: Placebo-dropsChildren will have to take placebo-drops |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Functional nausea (normal endoscopy findings)
Key exclusion criteria (3 listed)
- Gastrointestinal infection less than 2 weeks ago
- Known chronic gastrointestinal disease
- Use of drugs 2 weeks prior to starting the study
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 |
|---|---|---|
| AcupressureAlso: Seasickness-BandChildren will have to wear a 'seasickness-band', which has the effect of acupressure | Other | Acupressure |
| Placebo-bandChildren will have to wear a 'placebo-wristband' | Other | Placebo-band |
| IberogastChildren will have to take Iberogast drops | Drug | Iberogast |
| Placebo-dropsChildren will have to take placebo-drops | Other | Placebo-drops |
Primary outcome
comparison in the levels of nausea as assessed by visual analog scales (VAS)
Time frame: 4 weeks
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 6 Oct 2020.
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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.
Raoul Furlano, MD, Dr principal investigator
University Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Iberogast in people with Functional Nausea, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 3 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 6 Oct 2020. 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 Switzerland. 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?
comparison in the levels of nausea as assessed by visual analog scales (VAS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2020.