Comparison of the Therapeutic Effect of Acupressure Therapy and Iberogast ® (STW-5) in Children With Functional Nausea

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT02660970

Collaborator

(none)

Enrollment

Location

Arms

56.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Functional Nausea	Other: Acupressure Other: Placebo-band Drug: Iberogast Other: Placebo-drops	N/A

Detailed Description

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

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Sep 16, 2020

Actual Study Completion Date :

Sep 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acupressure Children will have to wear a 'seasickness-band', which has the effect of acupressure	Other: Acupressure Children will have to wear a 'seasickness-band', which has the effect of acupressure Other Names: Seasickness-Band
Placebo Comparator: Placebo-band Children will have to wear a 'placebo-wristband'	Other: Placebo-band Children will have to wear a 'placebo-wristband'
Active Comparator: Iberogast Children will have to take Iberogast drops	Drug: Iberogast Children will have to take Iberogast drops
Placebo Comparator: Placebo-drops Children will have to take placebo-drops	Other: Placebo-drops Children will have to take placebo-drops

Outcome Measures

Primary Outcome Measures

comparison in the levels of nausea as assessed by visual analog scales (VAS) [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pedriatric Gastroenterology, University Children's Hospital Basel	Basel	Basel Stadt	Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Principal Investigator: Raoul Furlano, MD, Dr, University Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT02660970

Other Study ID Numbers:

EKNZ 2015-322

First Posted:

Jan 21, 2016

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Keywords provided by University Hospital, Basel, Switzerland

Iberogast

Acupressure

gut-brain-axis

Additional relevant MeSH terms:

Nausea

Study Results

No Results Posted as of Oct 6, 2020