In short
Peucedanum ostruthium, also known as masterwort, is a plant extract being studied in a Phase 3 clinical trial for irritable bowel syndrome (IBS). The trial compares the herbal preparation Amara-Tropfen against placebo in 106 participants. The substance is not authorised as a medicine in the registry records provided.
Key points
- Phase 3 trial investigating Peucedanum ostruthium extract for irritable bowel syndrome.
- Trial compares Amara-Tropfen oral dilution against placebo.
- Enrollment of 106 participants.
- Primary outcome measures change in gastrointestinal discomfort intensity on a visual analogue scale.
- Trial status is Authorised in the EU Clinical Trials Information System.
What is Peucedanum ostruthium?
Peucedanum ostruthium, rhizoma REC., ethanol. decoctum 1:2,15 is a herbal substance prepared from the rhizome of the masterwort plant. In the trial record, it is given as an oral dilution under the product name Amara-Tropfen. The substance is classified as a herbal preparation. It is not authorised as a medicine in these registry records; it is being investigated as an experimental treatment.
How does Peucedanum ostruthium work?
The registry data provided do not describe a molecular mechanism of action for Peucedanum ostruthium. The trial is designed to measure whether the preparation changes the intensity of gastrointestinal discomfort in people with irritable bowel syndrome, but the way it might work is not stated in the source data.
Which conditions is it used or studied for?
- Irritable bowel syndrome (IBS) — a condition of the digestive system that can cause abdominal pain, bloating and changes in bowel habits. The trial studies whether Amara-Tropfen reduces the intensity of gastrointestinal discomfort in people with IBS.
How is Peucedanum ostruthium given?
In the trial, Peucedanum ostruthium is given as an oral dilution. The dose is reported as 1046 microlitres (µl) taken by mouth. The preparation is called Amara-Tropfen.
What do the clinical trials show?
One clinical trial is recorded for this substance in the data provided. It is a Phase 3 interventional study comparing Amara-Tropfen with placebo in 106 participants with irritable bowel syndrome.
What is the trial measuring?
The primary outcome is the change in intensity of gastrointestinal discomfort, measured on a visual analogue scale (VAS) from 0 to 100 millimetres, where 0 means no discomfort and 100 means the most intense discomfort. The trial compares the weekly mean VAS value after randomisation through eight weeks of treatment against the baseline value, which is the mean of at least four VAS values recorded during the seven days before randomisation.
Who can take part in this trial?
The trial enrols patients with irritable bowel syndrome. The registry record does not list additional inclusion or exclusion criteria such as age limits or specific IBS subtypes.
What is the status of the trial?
The trial is listed as Authorised in the EU Clinical Trials Information System. The record does not state whether recruitment has started or whether results are available.