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Study on Peppermint Oil and Caraway Oil for Patients with Functional Gastrointestinal Disorders

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment called Menthacarin on individuals with functional gastrointestinal disorders. These disorders can cause symptoms like abdominal pain, bloating, and a feeling of fullness after eating. The treatment being tested is a combination of two natural oils: peppermint oil and caraway oil, which are provided in a special type of capsule designed to resist stomach acid.

The purpose of the study is to assess how well the treatment can relieve symptoms and how it affects the quality of life and satisfaction with treatment. Participants will take the treatment over a period of time, and their symptoms will be monitored using simple rating scales. The study will also look at how the treatment impacts the gut's ability to function properly, including how it affects the frequency and consistency of bowel movements.

Throughout the study, participants will be asked to provide feedback on their symptoms and overall satisfaction with the treatment. This feedback will help researchers understand the effectiveness and tolerability of Menthacarin. The study aims to gather comprehensive information to determine if this treatment can be a beneficial option for people suffering from functional gastrointestinal disorders.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the clinical trial, the first step involves an initial visit to the investigational site. During this visit, eligibility is confirmed based on specific criteria, such as age and the presence of certain gastrointestinal symptoms.

    A written informed consent is required, which confirms understanding and agreement to participate in the trial. This consent is provided before any trial-related activities begin.

  2. Step 2

    Symptom assessment

    Participants are required to assess their symptoms using an 11-point numeric rating scale. This involves rating the intensity of symptoms like abdominal pain, cramping, and bloating.

    The assessment is conducted to establish a baseline of symptoms, which will be used for comparison throughout the trial.

  3. Step 3

    Medication administration

    Participants will begin taking the study medication, Carmenthin bei Verdauungsstörungen, which contains peppermint oil and caraway oil. The medication is administered orally in the form of gastro-resistant soft capsules.

    The dosage and frequency of the medication will be provided by the study team, and participants are expected to adhere to the prescribed regimen for the duration of the trial.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, participants will continue to monitor and record their symptoms using the numeric rating scale. This includes documenting any changes in symptom intensity and frequency.

    Participants will also track their bowel movements, including frequency and consistency, using the Bristol Stool Scale.

  5. Step 5

    Follow-up visits

    Scheduled follow-up visits at the investigational site are required. During these visits, participants will discuss their symptom changes, medication tolerability, and overall satisfaction with the treatment.

    Blood samples may be taken to measure specific serum parameters related to gut health.

  6. Step 6

    Final assessment

    At the end of the trial, a final assessment is conducted. Participants will provide a global assessment of the treatment's effectiveness and tolerability using a 5-point Likert scale.

    Participants will also complete a quality of life questionnaire and provide feedback on their satisfaction with the treatment.

Who can join the trial?

9 criteria

  • Adult male or female, 18 years or older.
  • Must provide written informed consent before starting any trial-related activities. This means you agree to participate after being fully informed about the study.
  • Must be willing and able to follow all trial procedures and attend all scheduled visits.
  • Must have a functional gastrointestinal disorder, experiencing at least one of the following symptoms at least 1 day per week for 3 months or more:
    • Abdominal pain or cramping
    • Bloating feeling
    • At the first visit, must have at least one of the following symptoms with an intensity of 4 or more on a scale from 0 to 10, at least one day in the last week:
      • Abdominal pain or cramping
      • Bloating feeling
      • Feeling very full after eating (postprandial fullness)
      • At the second visit, must still have at least one of the symptoms listed above with an intensity of 4 or more on a scale from 0 to 10, at least one day in the last week, as recorded in a daily diary.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have been diagnosed with a mental health disorder that is not well controlled.
  • Patients who are taking medications that could interfere with the study treatment.
  • Patients who have a history of severe gastrointestinal diseases other than functional gastrointestinal disorders.
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Investigated drugs

Menthacarin is a medication used in this clinical trial to help treat functional gastrointestinal disorders. It is a combination of peppermint oil and caraway oil. These natural oils are known for their soothing effects on the digestive system. Menthacarin works by relaxing the muscles in the stomach and intestines, which can help reduce symptoms like bloating, stomach pain, and discomfort. The trial aims to see how well Menthacarin can improve these symptoms and how it affects the overall quality of life for patients. Additionally, the study will look at how the medication influences gut permeability, which is how easily substances can pass through the gut lining.

What is already known about the treatment

Menthacarin – Menthacarin is administered orally and is used to treat functional gastrointestinal disorders, which are conditions affecting the digestive system. It is currently being studied in clinical trials to evaluate its effectiveness in reducing symptoms and improving the quality of life for patients with these disorders. Menthacarin works by influencing gut function, potentially affecting gut permeability, which is how easily substances pass through the gut wall. It is classified as a gastrointestinal agent, which means it is used to manage digestive system issues.

Investigated diseases

Functional Gastrointestinal Disorders – These are a group of disorders characterized by chronic or recurrent gastrointestinal symptoms that cannot be explained by structural or biochemical abnormalities. The symptoms often include abdominal pain, bloating, and changes in bowel habits such as diarrhea or constipation. The progression of these disorders can vary, with symptoms fluctuating in intensity and frequency over time. They are believed to result from a combination of factors, including altered gut motility, visceral hypersensitivity, and brain-gut interaction disturbances. Stress and diet can also influence the severity and occurrence of symptoms. The disorders are typically managed by addressing symptoms and improving quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501800-92-00Protocol codeD.02.01.2.02Estimated enrolment120 patientsSponsorDr. Willmar Schwabe GmbH & Co. KG

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