Study to Learn More About the Onset of Effect of Iberogast in Patients Suffering From Abnormal Stomach and Intestine Function

Study Overview
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Brief Summary
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Several studies have been done on the efficacy of the herbal medicine Iberogast. In this study researcher want to learn more about the time needed for Iberogast to start to work after the patient took the drug. This study plans to enroll 300 adult male and female patients suffering from disturbance of stomach and intestine normal function and treated by their doctor with Iberogast drops. Patients will be asked to document on a diary card the changes of symptom severity of the stomach and intestine complaints and the time needed for the symptoms to improve after drug intake. At the end of the study the treating doctor and the patients will be asked about the overall changes of symptoms. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected

Official Title
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Non-interventional Study on the Onset of Effect of Iberogast in Patients With Functional or Motility-related Gastrointestinal Diseases

Conditions
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Functional Gastrointestinal Disorders

Intervention / Treatment
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* Drug: STW5 (Iberogast®, BAY98-7411)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: At the discretion of physician under the instructions of Rome III criteria concerning functional gastrointestinal symptoms as well as the summary of product characteristics of Iberogast Exclusion criteria: Therapeutic necessity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: STW5 (Iberogast®, BAY98-7411)|The medication was applied 3 x 20 drops per day orally, before or at meals with some liquid, ideally three weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of GIS score from baseline up to 3 weeks after treatment | Gastrointestinal System Profile (GIS) includes 5 scores: 0=Not available, 1=Slight, 2=Moderate, 3=Severe, 4=Very severe | At baseline and up to 3 weeks post-treatment | 
| Global assessment by the physicians using a 4-point likert scale | Therapeutic success assessed by physicians. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms | Up to 3 weeks | 
| Global assessment by the patient using a 4-point likert scale | Therapeutic success assessed by patient. 0=Not improved, 1=Slightly improved, 2=Significantly approved, 3=No symptoms | Up to 3 weeks | 
| Change of ratings of symptom severity on a 100-mm visual analogue scale (VAS) over time after intake of Iberogast | Visual Analogue Scale to evaluate the general severity of symptoms. It is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no symptoms) to 100 mm (severe symptoms). | At baseline and up to 2 hours post-treatment on day 1 | 
| Onset of improvement assessed by patient on day 1 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 1 | On day 1 | 
| Onset of improvement assessed by patient on day 2 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 2 | On day 2 | 
| Onset of improvement assessed by patient on day 3 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 3 | On day 3 | 
| Onset of improvement assessed by patient on day 4 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 4 | On day 4 | 
| Onset of improvement assessed by patient on day 5 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 5 | On day 5 | 
| Onset of improvement assessed by patient on day 6 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 6 | On day 6 | 
| Onset of improvement assessed by patient on day 7 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 7 | On day 7 | 
| Onset of improvement assessed by patient on day 8 | The onset of effect (severity of the functional gastrointestinal symptoms as well as the time frame within which the symptoms improved) was documented by the patients in the patient diary card. According to the time frame stated in the card (1 minute, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, more than 2 hours), the patients had to mark the time with a cross at which their symptoms significantly improved (i.e. perceived by the patient) following the one-time intake of Iberogast at morning, noon and evening on day 8 | On day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with adverse events | Participants who had adverse events during the study | Up to 3 weeks | 
| The number of participants who discontinued from treatment | Participants who discontinued from study treatment | Up to 3 weeks | 
| The number of participants with the need of further treatment | Participants who needed further treatment | Up to 3 weeks |