AuthorisedTherapeutic use (Phase IV)Interventional

A prospective, exploratory, parallel-group, low-intervention, phase IV, randomized, double-blind, placebo-controlled, multi-center, national, 2-arm trial to investigate efficacy and safety of Amara-Tropfen (Amara drops) in patients with irritable bowel syndrome (IBS)

Irritable bowel syndrome (IBS) is a common condition that affects the digestive system, causing symptoms such as stomach cramps, bloating, diarrhoea, and constipation. This study is testing an established herbal medicine called Amara drops (Amara-Tropfen) to see if it can safely relieve these everyday discomforts. Participants will take either the Amara drops or a dummy treatment (placebo) every day for eight weeks. A computer randomly decides who receives which treatment, and neither the participants nor the research team will know who is taking what until the study ends. Throughout the trial, participants track their tummy pain, bloating, and bowel habits using simple rating scales. By comparing the results, doctors hope to discover whether Amara drops are a helpful, reliable option for people managing IBS.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Weleda AG

Enrolment target

106

Start

28 Aug 2026

Irritable Bowel Syndrome

What is this study about?

Irritable bowel syndrome (IBS) is a widespread gut disorder that can make everyday life difficult. People with IBS often experience uncomfortable symptoms such as abdominal pain, painful bloating, sudden urges to use the toilet, or irregular bowel habits. While there are existing treatments, many people continue to look for gentle, effective options to manage their flare-ups.

Amara drops are a traditional herbal medicine made from bitter plant extracts, which have long been used to support digestion. This Phase IV clinical study is designed to carefully test how well these drops work for IBS under strict scientific conditions. Because the drops are already in therapeutic use, researchers are gathering more detailed evidence about their true effectiveness and everyday safety.

To ensure fair results, this is a double-blind, randomised trial. Half of the participants receive Amara drops and half receive a matching dummy liquid (placebo). Neither you nor your study doctor will know which one you have received. You will use a simple visual scale to grade your tummy discomfort and answer questions about how your gut feels each week.

Finding new ways to soothe IBS is crucial for improving quality of life. If the study shows that Amara drops significantly calm bowel symptoms compared to a dummy treatment, it could give patients and doctors another trusted choice for managing IBS in the future.

Key takeaways

Tests whether herbal Amara drops can relieve IBS symptoms like pain and bloating.
Compares the active herbal drops against a dummy liquid (placebo) over 8 weeks.
Open to adults aged 18 and older living with irritable bowel syndrome.
Involves regular clinic visits and tracking symptoms in a simple daily diary.
Participation is completely voluntary and you can leave at any time.

Who may be eligible?

This study is open to men and women aged 18 and over who have been diagnosed with irritable bowel syndrome (IBS) and are currently experiencing gut symptoms such as pain or bloating.

To take part, you will need to be able to follow the study routine, which includes taking the liquid drops as directed and recording your daily symptoms honestly in a diary for around nine weeks (one preparation week followed by eight treatment weeks).

People with certain other serious digestive conditions or those taking specific medications that could interfere with the study results may not be able to join. The study doctor will review your full medical history with you to ensure it is completely safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with irritable bowel syndrome (IBS).
I currently experience gut symptoms like stomach pain, bloating, or irregular bowel habits.
I am happy to take liquid drops daily for 8 weeks.
I am able to fill in a symptom diary and attend regular clinic appointments.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for about nine weeks in total. First, you will spend one week recording your usual IBS symptoms in a daily diary to create a starting baseline. If you qualify, you will then be randomly assigned to take either Amara drops or a placebo liquid for eight weeks. You will attend around five clinic visits where doctors will check your general health, review your symptoms, and ask you to fill in short questionnaires about belly pain, bloating, and bowel satisfaction. You will also score your tummy discomfort each week on a simple visual scale from 0 (no discomfort) to 100 (most intense discomfort).

Potential risks and benefits

You may experience improvements in your IBS pain and digestion during the study, although this cannot be guaranteed. The study also helps improve medical knowledge for others with IBS. As Amara drops are made from plant extracts, there is a small chance of mild side effects such as an upset stomach, nausea, or an allergic reaction. There is also a 50% chance you will receive a dummy liquid that contains no active medicine. Your participation is entirely voluntary, and you are free to leave the trial at any point without it affecting your regular NHS medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What are Amara drops?

Amara drops are an established liquid herbal medicine made from bitter plant extracts, traditionally used to help soothe upset stomachs and support digestion.

What is a placebo?

A placebo is an inactive 'dummy' liquid designed to look, smell, and taste like the real medicine, allowing researchers to see if the active herbal drops make a genuine difference.

Can I choose to have the real drops instead of the placebo?

No. A computer randomly selects who receives the real drops and who receives the placebo, ensuring the trial results remain unbiased and scientifically sound.

Does taking part cost anything?

No, the study medicine and all study-related visits and checks are provided free of charge, and some travel expenses may be reimbursed.

What happens if my symptoms get worse?

Your health and comfort are the top priority. If your symptoms worsen or you feel unwell, you can contact the study team immediately, and you can stop the trial at any time.