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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
medicoKIT GmbH	Goch	Germany
Cewy Gcw	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.10.2023

Trial locations

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.

Investigated diseases:

Dyspepsia

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 ID:

2023-504750-35-01

Protocol code:

CGB_1109

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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