In short
Salvia officinalis, ethanol. infusum Ø is a herbal extract prepared from sage leaves. It is an investigational substance that has been studied in a Phase 3 clinical trial for irritable bowel syndrome (IBS). The trial, registered as 2026-526668-19-00, involved 106 participants and compared the extract against a placebo.
Salvia officinalis, ethanol. infusum Ø is a herbal substance prepared as an ethanolic infusion from sage (Salvia officinalis). It is an investigational product that has been studied in a Phase 3 clinical trial for irritable bowel syndrome (IBS).
Key points
- Salvia officinalis, ethanol. infusum Ø is a herbal extract made from sage leaves.
- The substance is being investigated in a Phase 3 trial for irritable bowel syndrome (IBS).
- One registered trial, 2026-526668-19-00, included 106 participants.
- The trial compared the herbal extract with a placebo over an 8-week treatment period.
- The main outcome measured was a change in gastrointestinal discomfort using a visual analogue scale.
What is Salvia officinalis, ethanol. infusum Ø?
Salvia officinalis, ethanol. infusum Ø is a herbal extract produced by ethanol infusion of sage leaves. It is an investigational substance that has not been authorised as a medicine in these records. The name of the extract indicates the plant source (Salvia officinalis, common sage), the solvent used for extraction (ethanol), and the preparation method (infusum Ø, an undiluted infusion).
How does Salvia officinalis, ethanol. infusum Ø work?
The exact mechanism of action of Salvia officinalis, ethanol. infusum Ø in humans has not been fully established in the available sources. Research on a related herbal Amara extract, which contains Artemisia absinthium, Centaurium erythraea, Cichorium intybus, and Gentiana lutea, has shown that such bitter herbal preparations can induce relaxation of the gastric fundus via inhibition of the M2 muscarinic receptor. This preclinical finding suggests a possible mechanism by which bitter herbal extracts may influence gastrointestinal function, although it does not directly describe the specific effects of Salvia officinalis, ethanol. infusum Ø.
Which conditions is Salvia officinalis, ethanol. infusum Ø studied for?
- Irritable bowel syndrome (IBS) — a common gastrointestinal disorder characterised by abdominal discomfort, bloating, and altered bowel habits. The Phase 3 trial investigated whether the herbal extract could reduce the intensity of gastrointestinal discomfort in people with IBS.
How is Salvia officinalis, ethanol. infusum Ø given?
In the registered clinical trial, the substance was given as an oral dilution. The trial record describes the intervention as "Amara-Tropfen Dilution (1046 µl microlitre(s), ORAL)". This indicates that the herbal extract was administered by mouth in liquid form as drops.
What do the clinical trials show?
One Phase 3 clinical trial has been registered for Salvia officinalis, ethanol. infusum Ø. The trial, with the EU CT number 2026-526668-19-00, is titled "Amara-Tropfen vs. placebo for irritable bowel syndrome (IBS)".
The trial was authorised and enrolled 106 participants. It was an interventional study comparing the herbal extract (verum) against a placebo. The primary outcome measured the change in intensity of gastrointestinal discomfort using a weekly mean of a visual analogue scale (VAS), where 0 mm represented no discomfort and 100 mm represented the most intense discomfort. Measurements were taken after randomisation until the end of the 8-week treatment period and compared with a baseline value obtained from at least 4 VAS values documented during the 7 days prior to randomisation.
The main objective stated in the trial record was to investigate the efficacy of the verum compared to placebo in patients with IBS, specifically in terms of the change in intensity of discomfort using the weekly mean of a VAS after randomisation until the end of the treatment period, compared to baseline.
What side effects are known?
The available sources do not provide information on side effects of Salvia officinalis, ethanol. infusum Ø. No adverse event data from the registered trial or from the supplementary source has been included in this page.