In short
Artemisia absinthium, herba REC., ethanol. EXTR. 1:2,3 is a herbal extract from the wormwood plant. In the European Union, it is registered as an investigational substance and is currently being studied in a Phase 3 clinical trial for irritable bowel syndrome (IBS). The trial is authorised and plans to enrol 106 participants. It compares a product called Amara-Tropfen with a placebo.
Key points
- Phase 3 trial in irritable bowel syndrome (IBS) with 106 planned participants.
- The trial is authorised but not yet recruiting or completed.
- Compares Amara-Tropfen (an oral dilution) with a placebo.
- Main measure: change in gastrointestinal discomfort on a visual analogue scale (VAS).
- Treatment lasts 8 weeks after a 7-day baseline period.
- Registry record: 2026-526668-19-00 in the EU Clinical Trials Information System.
What is Artemisia absinthium?
Artemisia absinthium, herba REC., ethanol. EXTR. 1:2,3 is a herbal substance prepared from the herb of the wormwood plant, Artemisia absinthium. The name describes a recorded herbal preparation made by ethanol extraction at a ratio of 1 part herb to 2.3 parts solvent. In the trial record, the study product is called Amara-Tropfen, which is given as an oral dilution. This substance is an investigational herbal preparation; the registry does not list a marketing authorisation for it as a medicine in this form.
How does Artemisia absinthium work?
The trial registry does not describe a molecular mechanism of action for this herbal extract. Wormwood preparations have traditionally been used as bitter-tasting herbal remedies, but the source data for this page does not state how the extract is thought to act in irritable bowel syndrome. The authorised trial is designed to measure whether the product reduces gastrointestinal discomfort compared with placebo, rather than to explain its mechanism.
Which conditions is it used or studied for?
- Irritable bowel syndrome (IBS) — a long-term condition of the digestive system that can cause abdominal discomfort, bloating, and changes in bowel habits. This is the only condition listed for the registered trial.
How is Artemisia absinthium given?
In the registered trial, the study product is given as an oral dilution. The intervention is described as Amara-Tropfen Dilution at a volume of 1046 microlitres, taken by mouth. The trial record does not state the daily schedule or how the dilution is prepared by the patient.
What do the clinical trials show?
One clinical trial is registered for this substance in the EU Clinical Trials Information System. It is a Phase 3, interventional study in irritable bowel syndrome. The trial is authorised, meaning it has received regulatory approval to proceed, but the registry does not report results yet. The planned number of participants is 106.
The study compares the herbal product Amara-Tropfen with a placebo. The main outcome is the change in the intensity of gastrointestinal discomfort, measured each week on a visual analogue scale (VAS) from 0 to 100 mm, where 0 means no discomfort and 100 means the most intense discomfort. The change is measured from a baseline of at least four VAS values recorded during the seven days before randomisation, through to the end of eight weeks of treatment.
Who can take part in the trial?
The registry record does not list detailed eligibility criteria such as age range, sex, or specific IBS subtype. The trial is designed for patients with irritable bowel syndrome, and the planned enrolment is 106 participants. People interested in taking part would need to check the full entry criteria in the registry record.
What side effects are known?
The registry record for this trial does not include information on side effects. No supplementary sources on adverse effects were provided for this page.