In short
Centaurium erythraea, herba REC., ethanol. EXTR. 1:2,3 is a herbal extract being studied in irritable bowel syndrome (IBS). One Phase 3 trial is currently authorised, planning to enrol 106 participants. The trial compares Amara-Tropfen, a dilution containing the extract, against placebo over an 8-week treatment period.
Key points
- Phase 3 trial in irritable bowel syndrome (IBS) with 106 planned participants.
- Compares Amara-Tropfen (an oral dilution) against placebo.
- Primary measure: change in gastrointestinal discomfort on a visual analogue scale (VAS).
- Treatment lasts 8 weeks, with a baseline measured over 7 days before randomisation.
- Trial status: Authorised, meaning it has not yet started recruiting.
What is Centaurium erythraea?
Centaurium erythraea, herba REC., ethanol. EXTR. 1:2,3 is a herbal extract prepared from the herb of Centaurium erythraea, a plant also known as common centaury. It is an investigational substance in the context of the registered trial, meaning it has not been authorised as a medicine for irritable bowel syndrome in these records. The extract is used in a product called Amara-Tropfen, which is given as an oral dilution.
How does Centaurium erythraea work?
The registry record does not describe a molecular mechanism of action for Centaurium erythraea, herba REC., ethanol. EXTR. 1:2,3. The trial is designed to measure whether the extract reduces the intensity of gastrointestinal discomfort in people with irritable bowel syndrome, but the biological pathway is not stated in the available data.
Which conditions is it used or studied for?
- Irritable bowel syndrome (IBS) – a common condition affecting the digestive system, causing symptoms such as abdominal discomfort, bloating, and changes in bowel habits. The registered trial studies Centaurium erythraea in this condition.
How is Centaurium erythraea given?
In the registered trial, the substance is given as an oral dilution called Amara-Tropfen. The reported dose is 1046 microlitres, taken by mouth. The pharmaceutical form is a dilution, and the route of administration is oral.
What do the clinical trials show?
One clinical trial is registered for Centaurium erythraea, herba REC., ethanol. EXTR. 1:2,3. It is a Phase 3 trial in irritable bowel syndrome with a planned enrolment of 106 participants. The trial is authorised but has not yet started, so no results are available yet.
What is the trial measuring?
The primary outcome is the change in the intensity of gastrointestinal discomfort, measured using a visual analogue scale (VAS) from 0 to 100 mm, where 0 means no discomfort and 100 means the most intense discomfort. The trial compares the weekly mean VAS value during the 8-week treatment period against the baseline value, which is the mean of at least 4 VAS values documented during the 7 days before randomisation.
Who can take part?
The trial enrols patients with irritable bowel syndrome. The registry record does not list further eligibility criteria such as age limits or specific IBS subtypes.
What side effects are known?
The registry record does not report side effects for Centaurium erythraea, herba REC., ethanol. EXTR. 1:2,3. As the trial has not yet started, safety data from this study are not available.