Menthacarin® in the treatment of functional gastrointestinal disorders

Conditions

functional gastrointestinal disorders

Brief summary

Symptom rating by the patient using 11-point numeric rating scales,, The sum of patient symptom rating of all abdominal symptoms,, Global question on symptom impact,, Most bothersome abdominal symptom,, Stool frequency via Frequency of Spontaneous Bowel Movements (SBMs),, Stool consistency via Bristol Stool Scale,, Satisfaction with change in bowel habits,, Global assessment of effectiveness, on a 5-point Likert scale, Patient´s satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS),, Quality of Life Questionnaire (SF 12),, Patient’s willingness to recommend Menthacarin,, Serum parameters: Zonulin and Intestinal-fatty acid binding protein (I-FABP), Adverse events, Global assessment of tolerability on a 5-point Likert scale

Detailed description

Due to the character of the trial, no differentiation in primary and secondary outcome variables is intended

Related papers

No related papers found yet.

Interventions

DRUGCarmenthin bei Verdauungsstörungen

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Symptom rating by the patient using 11-point numeric rating scales,, The sum of patient symptom rating of all abdominal symptoms,, Global question on symptom impact,, Most bothersome abdominal symptom,, Stool frequency via Frequency of Spontaneous Bowel Movements (SBMs),, Stool consistency via Bristol Stool Scale,, Satisfaction with change in bowel habits,, Global assessment of effectiveness, on a 5-point Likert scale, Patient´s satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS),, Quality of Life Questionnaire (SF 12),, Patient’s willingness to recommend Menthacarin,, Serum parameters: Zonulin and Intestinal-fatty acid binding protein (I-FABP), Adverse events, Global assessment of tolerability on a 5-point Likert scale	—

Measure

Time frame

Symptom rating by the patient using 11-point numeric rating scales,, The sum of patient symptom rating of all abdominal symptoms,, Global question on symptom impact,, Most bothersome abdominal symptom,, Stool frequency via Frequency of Spontaneous Bowel Movements (SBMs),, Stool consistency via Bristol Stool Scale,, Satisfaction with change in bowel habits,, Global assessment of effectiveness, on a 5-point Likert scale, Patient´s satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS),, Quality of Life Questionnaire (SF 12),, Patient’s willingness to recommend Menthacarin,, Serum parameters: Zonulin and Intestinal-fatty acid binding protein (I-FABP), Adverse events, Global assessment of tolerability on a 5-point Likert scale

—

Secondary

Measure	Time frame
Due to the character of the trial, no differentiation in primary and secondary outcome variables is intended	—

Countries

Germany

Outcome results

None listed