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Randomised, placebo-controlled clinical trial on the efficacy of Roleca® juniper 100 mg for dyspeptic digestive complaints such as cramps in the gastrointestinal tract, flatulence and bloating.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504750-35-01
Acronym
CGB_1109
Enrollment
100
Registered
2023-09-26
Start date
2023-10-24
Completion date
2025-02-20
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of dyspeptic digestive complaints (cramps in the gastrointestinal tract, flatulence, bloating).

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

DRUGRoleca Wacholder 100mg

Sponsors

CGBS GbR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Secondary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026