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Efficacy and Safety of Amara‑Tropfen Dilution vs Placebo in Patients with Irritable Bowel Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Irritable Bowel Syndrome is a common condition that causes recurring abdominal pain, bloating, and changes in bowel habits. The trial is testing an oral liquid called Amara-Tropfen, which contains a mixture of plant extracts, against a placebo.

The purpose of the study is to see whether Amara‑Tropfen can reduce the intensity of gastrointestinal discomfort compared with placebo. Participants will be randomly assigned to receive either the drops or the placebo for eight weeks. During the study they will keep a simple daily diary in which they rate their discomfort on a visual analogue scale (VAS), a line marked from 0 (no discomfort) to 100 (most intense discomfort). They will also attend a few clinic visits to answer questionnaires about their bowel symptoms and overall quality of life, and any unwanted effects will be recorded for safety monitoring.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and receipt of study medication

    After joining the study you will be assigned by chance to receive either the active product amara-tropfen or a matching placebo. the assignment is unknown to you and the study staff.

    You will receive a bottle of oral drops containing either the active preparation or the placebo. Each bottle is labelled with a study code, not the product name.

  2. Step 2

    Daily medication intake

    Take 1046 µl (approximately one milliliter) of the drops by mouth each day.

    The dose should be taken at roughly the same time each day, with or without food, as instructed in the study booklet.

    Continue this daily intake for the whole treatment period, which lasts eight weeks (treatment weeks 1 through 8).

  3. Step 3

    Recording daily symptoms

    Each day you will mark a visual analogue scale (VAS) to indicate the intensity of any gastrointestinal discomfort. The scale runs from 0 (no discomfort) to 100 (most intense discomfort).

    The daily VAS scores are used to calculate a weekly average. These averages will be collected for each week of the eight‑week treatment period.

    The same recording method is used during the baseline week (the seven days before randomization) to provide a reference value.

  4. Step 4

    Study visits and questionnaires

    You will attend three scheduled visits during the treatment period, referred to as visit 3, visit 4, and visit 5.

    At each visit you will complete the irritable bowel syndrome severity scoring system (IBS‑sss) questionnaire, which asks about abdominal pain, number of painful days, abdominal distension, satisfaction with bowel habits, and overall impact on daily life.

    You will also complete the irritable bowel syndrome quality of life (IBS‑qol) questionnaire at visit 4, and the pagi‑sym questionnaire (which covers symptoms such as heartburn, nausea, fullness, bloating, and abdominal pain) at each visit.

    The investigator will ask you about any side effects you may have experienced and will record any adverse events.

  5. Step 5

    End of treatment and final assessment

    After the eighth week of medication you will have a final assessment, which includes the same questionnaires as before and a review of all recorded VAS scores.

    The investigator will ask whether you would continue the medication outside the study and will evaluate the overall safety and efficacy of the product you received.

    If you experienced a serious side effect or lack of benefit, you may be asked to stop the medication early; this will be documented as a discontinuation.

Who can join the trial?

8 criteria

  • Age: You must be at least 18 years old and not older than 75 years, and any gender is allowed.
  • Diagnosis of Irritable Bowel Syndrome (IBS): You need to meet the German IBS guideline, which means you have had bowel‑related pain or discomfort for more than three months, the symptoms affect your daily life, and no other disease explains them. If you are under 50 years old, you must have had a normal colonoscopy (a camera exam of the large intestine) within the last 5 years or a stool test called Calprotectin showing less than 100 mg/kg within the past 8 weeks. If you are 50 years or older, a normal colonoscopy within the last 5 years is required.
  • Discomfort level: Your average pain or discomfort over a week must be at least 40 mm on a 100 mm Visual Analogue Scale (VAS), which is a straight line where you mark how bad the feeling is.
  • IBS severity score: Your score on the Irritable Bowel Syndrome Severity Scoring System (IBS‑SSS) must be 175 or higher, indicating moderate to severe symptoms.
  • Body weight: Your body mass index (BMI), a measure of weight relative to height, must be 40 or lower.
  • Commitment: You must be willing and able to complete all study visits, questionnaires, and other procedures for the whole trial period.
  • Contraception for women who could become pregnant: Female participants who are able to have children must use a highly effective birth‑control method from the screening visit until the end of the study.
  • Informed consent: You must sign a consent form that explains the study before any study‑related activities begin.

Who cannot join the trial?

16 criteria

  • Taking any medication that contains the active ingredients of Amara‑Tropfen now or within the past 28 days.
  • Using any therapy that the study does not allow (see the study’s rules for “not permitted therapy”).
  • Changing important medical treatments (for example, a proton pump inhibitor for stomach acid or antidepressants) in the 28 days before the first study visit, or planning to change them while the study is running.
  • Changing any IBS medication or its dose in the 28 days before the first study visit.
  • Having had major abdominal surgery (such as removal of the appendix, uterus, gallbladder, or hernia repair) within the last 5 years.
  • Having an active severe infection disease.
  • Having diabetes mellitus type I or type II (a condition where the body cannot control blood sugar properly).
  • Having a serious body condition such as very poor kidney function, severe liver disease, severe lung disease, or long/post‑COVID problems.
  • Having had cancer (malignancy) in the past 5 years, except for basal cell skin cancer or melanoma in‑situ (early‑stage skin cancers).
  • Having a clinically important psychiatric condition, shown by a score of 14 or higher on each part of the Hospital Anxiety and Depression Scale (HADS).
  • Being allergic or intolerant to Cichorium, other members of the Asteraceae plant family, or any part of the study medication.
  • Having any condition that would make it hard to take part in the study, such as drug or alcohol abuse, very severe diarrhea (watery stools more than three times a day) or very severe constipation (hard stools fewer than three times a week).
  • Having a positive urine pregnancy test (for women who could become pregnant) or being breastfeeding.
  • Being a resident of a psychiatric ward, prison, or other state institution.
  • Participating in another clinical trial or having taken another study medication within the last 3 months (or longer, depending on the drug’s “half‑lives,” which is the time it takes for half of the drug to leave the body).
  • Being a staff member of the study sites, the contract research organization (CRO), the sponsor company, or any member of the trial team.
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Investigated drugs

Amara‑Tropfen Dilution is an oral drops solution that contains a mixture of herbal extracts. It includes extracts from plants such as mugwort, centaury, chicory, gentian, juniper, milfoil, peucedanum, sage, and dandelion. In the trial, participants take these drops by mouth. The purpose of using this product is to test whether the combination of these herbal ingredients can reduce the discomfort experienced by people with irritable bowel syndrome (IBS) compared with a placebo. The study measures changes in pain and discomfort levels over several weeks to see if the drops provide a noticeable benefit.

What is already known about the treatment

  • Placebo

    This product is a sugar‑water solution given as oral drops, taken by mouth like a regular medicine but containing no active ingredients. It is widely used as an inert control in clinical research and has no therapeutic status in medical practice. Because it contains no active substances, it has no specific therapeutic indication, no molecular mechanism, and is classified simply as an inert control or dummy treatment.

  • Amara‑Tropfen Dilution

    The medication is supplied as oral drops (a liquid solution) that are taken by mouth, delivering a very dilute mixture of several herbal extracts. It is a herbal medicinal product that is currently used in complementary medicine and has limited scientific literature, not being a standard approved drug. The drops are intended to relieve symptoms of irritable bowel syndrome by helping to calm gut muscle activity and reduce mild inflammation. Its action is thought to come from plant compounds that influence gut nerves and smooth‑muscle tone, placing it in the phytotherapeutic (herbal) classification.

Investigated diseases

Irritable Bowel Syndrome - A functional disorder of the large intestine that causes recurring abdominal pain and changes in bowel habits such as diarrhea, constipation, or alternating between both. The discomfort often appears after meals and may be relieved by a bowel movement. Symptoms tend to come and go, with periods of worsening followed by times of relative calm. Stress, certain foods, and hormonal changes can trigger flare‑ups. Over time, the frequency and intensity of episodes may increase, leading to more noticeable patterns of pain, bloating, and irregular stool consistency.
Trial detailsLast updated 3 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526668-19-00Protocol codeDR-CR-AMA01S01Estimated enrolment106 patientsSponsorWeleda AG

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