Treatment of dyspeptic digestive complaints (cramps in the gastrointestinal tract, flatulence, bloating).
Conditions
Brief summary
Prospective documentation of the efficacy of Roleca® Juniper 100 mg vs placebo for dyspeptic digestive complaints, based on the improvement in the patients' quality of life, expressed in a change in the score in the Nepean Dyspepsia Index in the patient diary, with particular comparison of the values after the end of treatment (V3) with the values before treatment (V1) (in particular significant improvement in complaints and feeling of pressure in the upper abdomen and feeling of fullness).
Detailed description
Prospective documentation of the tolerability, safety and compliance of Roleca® Juniper 100 mg in dyspeptic digestive complaints. Tolerability and safety will be evaluated based on the patient's information in the patient diary regarding tolerability, as well as the number and severity of adverse events reported. Compliance will be analyzed based on documentation of medication taken in the patient diary., Analysis of the intestinal microbiome before and during treatment with Roleca® Wacholder 100 mg for dyspeptic digestive complaints
Interventions
Sponsors
Eligibility
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Prospective documentation of the tolerability, safety and compliance of Roleca® Juniper 100 mg in dyspeptic digestive complaints. Tolerability and safety will be evaluated based on the patient's information in the patient diary regarding tolerability, as well as the number and severity of adverse events reported. Compliance will be analyzed based on documentation of medication taken in the patient diary., Analysis of the intestinal microbiome before and during treatment with Roleca® Wacholder 100 mg for dyspeptic digestive complaints | — |
Primary
| Measure | Time frame |
|---|---|
| Prospective documentation of the efficacy of Roleca® Juniper 100 mg vs placebo for dyspeptic digestive complaints, based on the improvement in the patients' quality of life, expressed in a change in the score in the Nepean Dyspepsia Index in the patient diary, with particular comparison of the values after the end of treatment (V3) with the values before treatment (V1) (in particular significant improvement in complaints and feeling of pressure in the upper abdomen and feeling of fullness). | — |
Countries
Germany