Randomized, Placebo-Controlled Trial Evaluating Juniper Berry Oil 100 mg for Dyspeptic Digestive Complaints in Adults

The primary objective of this study is to evaluate the **efficacy** of Roleca® juniper 100 mg in the treatment of **dyspeptic digestive complaints**, specifically targeting symptoms such as cramps in the gastrointestinal tract, flatulence, and bloating. This is a randomized, placebo-controlled clinical trial, which is crucial for determining the therapeutic potential of Roleca® juniper in managing these common gastrointestinal symptoms. The clinical relevance of this study lies in its potential to provide an effective treatment option for patients suffering from dyspeptic symptoms, which can significantly impact quality of life.

The clinical trial involves a study population comprising **adults** aged 18 to 59 years, inclusive of both **male** and **female** participants. The trial focuses on individuals experiencing persistent **dyspeptic digestive complaints**, such as cramps in the gastrointestinal tract, flatulence, and bloating, over the past three months. Participants are required to have signed informed consent and, for those of childbearing potential, a negative pregnancy test at the initial visit. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria emphasize the presence of mild discomfort in the upper abdomen, a feeling of pressure, and a sensation of fullness. Participants are expected to adhere to reliable contraceptive methods during the trial. Lifestyle factors such as diet and physical activity are not specified in the available data.

The clinical trial is designed as a **randomized, placebo-controlled** study to evaluate the efficacy of Roleca® Juniper 100 mg in treating dyspeptic digestive complaints, including cramps in the gastrointestinal tract, flatulence, and bloating. The trial will involve participants aged 18 to 59 years who have experienced persistent dyspeptic symptoms over the past three months. The study will be conducted over a period of 12 weeks, with the estimated recruitment start date being October 1, 2023, and the estimated end date being March 31, 2024.

Participants will be randomly assigned to receive either the active treatment, Roleca® Juniper 100 mg, in the form of a soft capsule, or a **placebo** tablet, both administered orally. The primary endpoint of the trial is to document the efficacy of the treatment by assessing improvements in the patients' quality of life, as measured by changes in the Nepean Dyspepsia Index scores from baseline to the end of treatment. Secondary endpoints include evaluating the tolerability, safety, and compliance of the treatment, as well as analyzing changes in the intestinal microbiome.

The sequence of study visits includes an initial screening visit to confirm eligibility, followed by regular follow-up visits to monitor progress and collect data. The end-of-study visit will assess the final outcomes and any adverse events. Participants are expected to be involved in the study for the entire 12-week duration unless conditions arise that necessitate early termination, such as significant adverse events or withdrawal of consent. The trial will ensure that all participants provide informed consent and adhere to reliable contraception methods if applicable.

The clinical trial involves the administration of **Roleca Wacholder 100mg**, a soft capsule containing **juniper berry oil** as the active substance. This investigational product is manufactured by MEDICONOMICS GMBH and is classified under the ATC code A16A, which pertains to other alimentary tract and metabolism products. The pharmaceutical form is a soft capsule, and the route of administration is oral. Participants will receive a maximum daily dose of 100 mg, with a total maximum dose of 36 grams over the course of the study. The treatment period is set for a maximum of 12 weeks. The compliance of participants with the dosing schedule will be monitored throughout the trial.

In addition to the experimental treatment, a **placebo** is used as a comparator in this randomized, placebo-controlled trial. The placebo is provided in the form of a tablet, known as P-Tabletten weiß 7 mm Lichtenstein, and is manufactured by WINTHROP ARZNEIMITTEL GMBH. The placebo tablets are chemically inert and are administered orally. The dosing schedule for the placebo mirrors that of the experimental treatment, with a maximum daily dose of 100 mg and a total maximum dose of 36 grams over the 12-week treatment period. The use of a placebo allows for the assessment of the efficacy of the experimental treatment in managing dyspeptic digestive complaints, such as cramps in the gastrointestinal tract, flatulence, and bloating.

The efficacy of Roleca® Juniper 100 mg in treating dyspeptic digestive complaints will be assessed through a randomized, placebo-controlled clinical trial. The primary endpoint for evaluating efficacy is the improvement in patients' quality of life, as measured by changes in the Nepean Dyspepsia Index score recorded in the patient diary. This assessment will focus on the comparison of scores before treatment (V1) and after the end of treatment (V3), with particular attention to significant improvements in symptoms such as discomfort and feeling of pressure in the upper abdomen, as well as a feeling of fullness.

Secondary endpoints include the documentation of tolerability, safety, and compliance of Roleca® Juniper 100 mg. Tolerability and safety will be evaluated based on patient-reported information in the patient diary, including the number and severity of adverse events. Compliance will be assessed through the documentation of medication intake in the patient diary. Additionally, an analysis of the intestinal microbiome will be conducted before and during treatment to further understand the effects of the intervention.