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Study on Juniper Berry Oil for Digestive Issues like Cramps, Gas, and Bloating in Adults

Registered 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 for dyspeptic digestive complaints, which include symptoms like cramps in the gastrointestinal tract, flatulence, and bloating. The treatment being tested is a soft capsule called Roleca Wacholder 100mg, which contains juniper berry oil. The study will compare the effects of this treatment with a placebo, which is a tablet that looks like the treatment but does not contain the active ingredient.

The purpose of the study is to evaluate how effective Roleca Wacholder 100mg is in relieving these digestive symptoms. Participants will take the treatment or placebo orally for a period of up to 12 weeks. Throughout the study, participants will be asked to keep a diary to record their symptoms and any changes they experience. This will help researchers understand how the treatment affects the quality of life of those with dyspeptic digestive complaints.

In addition to assessing the effectiveness of the treatment, the study will also look at how well participants tolerate the treatment and any side effects they might experience. Researchers will also analyze changes in the intestinal microbiome, which is the community of bacteria and other microorganisms living in the gut, before and during the treatment. This information will help determine the safety and overall impact of Roleca Wacholder 100mg on digestive health.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria: age between 18 and 59, persistent digestive symptoms for the past 3 months, and signing informed consent.

    A negative pregnancy test is required for those of childbearing potential, along with a commitment to use reliable contraception during the trial.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to document baseline symptoms, focusing on discomfort, pressure, and fullness in the upper abdomen.

    The Nepean Dyspepsia Index is used to evaluate the quality of life related to digestive complaints.

  3. Step 3

    Medication administration

    Participants receive either Roleca® juniper 100 mg or a placebo in the form of oral tablets or soft capsules.

    The medication is taken as directed, with the dosage and frequency specified by the study protocol.

  4. Step 4

    Ongoing monitoring

    Participants maintain a diary to document symptoms, medication intake, and any side effects experienced.

    Regular check-ins are scheduled to monitor progress and ensure compliance with the study protocol.

  5. Step 5

    Final assessment

    At the end of the treatment period, a final assessment is conducted to compare symptom changes using the Nepean Dyspepsia Index.

    The primary focus is on the improvement of symptoms such as discomfort, pressure, and fullness in the upper abdomen.

  6. Step 6

    Safety and tolerability evaluation

    The study evaluates the safety and tolerability of Roleca® juniper 100 mg based on diary entries and reported side effects.

    Compliance with the medication regimen is also assessed through the documentation provided by participants.

  7. Step 7

    Microbiome analysis

    An analysis of the intestinal microbiome is conducted before and during treatment to observe any changes related to the medication.

Who can join the trial?

6 criteria

  • Patients must be between the ages of 18 and 59 years old.
  • Patients should have ongoing **dyspeptic digestive symptoms** for the past 3 months. These symptoms include cramps in the stomach area, gas, and bloating.
  • Patients need to sign a form agreeing to participate and allowing their personal data to be collected and shared in a way that keeps their identity private.
  • For those who can become pregnant, a negative pregnancy test is required at the first visit.
  • Patients must agree to use a reliable method of **contraception** during the study. This can include complete abstinence, sterilization procedures, partner's vasectomy, or various forms of hormonal and non-hormonal birth control.
  • Patients must experience at least mild discomfort in three specific areas: discomfort in the upper abdomen, a feeling of pressure in the upper abdomen, and a feeling of fullness.

Who cannot join the trial?

8 criteria

  • Patients who are under 18 years old cannot participate.
  • Patients who are pregnant or breastfeeding are not allowed to join the study.
  • Patients with a known allergy to any of the study's ingredients cannot take part.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with severe medical conditions that might interfere with the study are not eligible.
  • Patients who have had recent surgery affecting the digestive system cannot participate.
  • Patients with a history of alcohol or drug abuse are excluded from the study.
  • Patients who are unable to follow the study procedures or take the study medication as directed are not eligible.
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Investigated drugs

Roleca: This is a medication used in the trial to help with digestive issues. It is specifically aimed at relieving symptoms like cramps in the gastrointestinal tract, flatulence, and bloating. The active ingredient in Roleca is derived from juniper, which is known for its potential benefits in easing digestive discomfort.

What is already known about the treatment

Roleca® Juniper – This medication is administered orally in the form of a 100 mg tablet. It is currently being studied in a randomized, placebo-controlled clinical trial to assess its effectiveness in treating dyspeptic digestive complaints, including cramps in the gastrointestinal tract, flatulence, and bloating. The main therapeutic indication is for the relief of these digestive symptoms. At the molecular level, the active components in juniper are believed to work by reducing gastrointestinal spasms and gas formation, although the exact mechanism is still under investigation. Roleca® Juniper is classified pharmacologically as a herbal remedy used for digestive health.

Investigated diseases

Dyspeptic Digestive Complaints – This condition involves discomfort in the upper abdomen, often characterized by symptoms such as cramps in the gastrointestinal tract, flatulence, and bloating. It can lead to a feeling of fullness and pressure in the upper abdomen, which may affect daily activities and overall quality of life. The symptoms can vary in intensity and may be triggered by certain foods or stress. Dyspeptic complaints are common and can occur in individuals of all ages. The condition is not considered rare and is often managed through lifestyle changes and dietary adjustments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504750-35-01Protocol codeCGB_1109Estimated enrolment100 patientsSponsorCGBS GbR

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).