In short
Gentiana lutea, ethanol. decoctum Ø is a herbal preparation from the yellow gentian plant, studied as the active ingredient in Amara-Tropfen. It is being investigated in a Phase 3 clinical trial for irritable bowel syndrome (IBS). The trial includes 106 participants and is currently authorised to begin.
Key points
- Phase 3 trial in irritable bowel syndrome (IBS)
- 106 participants planned for enrolment
- Compares Amara-Tropfen against placebo
- Given orally as a dilution (1046 µl)
- Measures change in gastrointestinal discomfort on a visual analogue scale
- Trial status: Authorised
What is Gentiana lutea, ethanol. decoctum Ø?
Gentiana lutea, ethanol. decoctum Ø is a herbal substance prepared from the root of the yellow gentian plant (Gentiana lutea). In the clinical trial described here, it appears as the active ingredient of a product called Amara-Tropfen. The name includes "ethanol. decoctum Ø", which refers to an ethanolic decoction, a traditional method of preparing plant material by boiling it in a mixture of water and ethanol. The "Ø" symbol is used in homeopathic and anthroposophic medicine to denote a mother tincture or undiluted base preparation. The trial record does not state whether this product holds a marketing authorisation; it is being studied as an investigational medicinal product in a Phase 3 trial.
How does Gentiana lutea, ethanol. decoctum Ø work?
The trial record does not describe a molecular mechanism of action for Gentiana lutea, ethanol. decoctum Ø. Yellow gentian has traditionally been used as a bitter tonic, meaning it is thought to stimulate digestive secretions through its bitter taste. However, no mechanism is stated in the source data for this trial, so the exact way it might affect irritable bowel syndrome is not given here.
Which conditions is Gentiana lutea, ethanol. decoctum Ø used or studied for?
- Irritable bowel syndrome (IBS) — a common disorder of the gut that causes abdominal discomfort, bloating and changes in bowel habits. This is the only condition listed in the trial record.
How is Gentiana lutea, ethanol. decoctum Ø given?
In the trial, the product Amara-Tropfen is given orally as a dilution. The intervention is described as "Amara-Tropfen Dilution (1046 µl microlitre(s), ORAL)". This means participants receive a measured volume of the liquid preparation by mouth. The placebo arm is also given orally, allowing a blinded comparison between the two.
What do the clinical trials show?
One clinical trial is listed for this substance. It is a Phase 3 interventional study in irritable bowel syndrome, with a planned enrolment of 106 participants. The trial is currently authorised, meaning it has received regulatory approval to proceed but results are not yet available. The study compares Amara-Tropfen against placebo. Its main outcome measure is the change in intensity of gastrointestinal discomfort, assessed using a visual analogue scale (VAS) from 0 to 100 mm, where 0 means no discomfort and 100 means the most intense discomfort. Measurements are taken weekly from the start of treatment through week 8, compared with a baseline recorded during the 7 days before randomisation.
Who can take part in these trials?
The trial record does not list detailed eligibility criteria such as age range, sex or specific diagnostic requirements. It states only that participants are patients with irritable bowel syndrome. Anyone interested in taking part would need to consult the full trial record, which is available in the EU Clinical Trials Information System under the identifier 2026-526668-19-00.
What side effects are known?
No side effect information is provided in the source data for this trial. The trial record does not list known adverse reactions for Gentiana lutea, ethanol. decoctum Ø or for Amara-Tropfen.