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Randomised, placebo-controlled clinical trial on the efficacy of Roleca® juniper 100 mg for dyspeptic digestive complaints such as cramps in the gastrointestinal tract, flatulence and bloating.
EU CTIS ID: 2023-504750-35-01
What this study is testing
Randomised, placebo-controlled clinical trial on the efficacy of Roleca® juniper 100 mg for dyspeptic digestive complaints such as cramps in the gastrointestinal tract, flatulence and bloating.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of either sex between the ages of ≥ 18 years and < 60 years
- Outpatients with persistent dyspeptic digestive symptoms over the past 3 months
- Signed informed consent for participation and for collection and pseudonymized sharing of personal data
- Negative pregnancy test for persons of childbearing potential at visit 1
- Willingness to use a reliable method of contraception during participation in the clinical trial (Pearl index < 1): Complete abstinence, Sterilization (e.g., bilateral tubal ligation, ovariectomy, hysterectomy), Vasectomy of partner (if sole sexual partner), combined hormonal contraceptives (oral, intravaginal, dermal), progestogen-containing hormonal contraceptives, copper IUD, hormone-containing IUD
- The 3 specific parameters (discomfort in the upper abdomen, feeling of pressure in the upper abdomen and feeling of fullness) must be classified as at least mild discomfort.
You likely can't join if
- Uncooperative patients
- Patients with diabetes mellitus
- Patients in whom an organic cause for the dyspeptic complaints has been proven by diagnostics
- Hypersensitivity to juniper oil, lactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.) or microcrystalline cellulose.
- Allergy to the humectant sorbitol (E420)
- Patients with known galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
See the full eligibility criteria
- Patients of either sex between the ages of ≥ 18 years and < 60 years
- Outpatients with persistent dyspeptic digestive symptoms over the past 3 months
- Signed informed consent for participation and for collection and pseudonymized sharing of personal data
- Negative pregnancy test for persons of childbearing potential at visit 1
- Willingness to use a reliable method of contraception during participation in the clinical trial (Pearl index < 1): Complete abstinence, Sterilization (e.g., bilateral tubal ligation, ovariectomy, hysterectomy), Vasectomy of partner (if sole sexual partner), combined hormonal contraceptives (oral, intravaginal, dermal), progestogen-containing hormonal contraceptives, copper IUD, hormone-containing IUD
- The 3 specific parameters (discomfort in the upper abdomen, feeling of pressure in the upper abdomen and feeling of fullness) must be classified as at least mild discomfort.
- Uncooperative patients
- Patients with diabetes mellitus
- Patients in whom an organic cause for the dyspeptic complaints has been proven by diagnostics
- Hypersensitivity to juniper oil, lactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.) or microcrystalline cellulose.
- Allergy to the humectant sorbitol (E420)
- Patients with known galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
- Allergy to peanut or soy
- Existing alcohol abuse or medication or drug abuse
- Pregnant or breast-feeding patients or those who plan to become pregnant during the clinical trial
- Patients who are institutionalized by court order or by order of the authorities
- Patients incapable of giving consent
- Patients who do not have sufficient command of the German language (informed consent)
- Patients who are in a dependent relationship with the sponsor, investigator, other study personnel, or the study site
- Patients with inflammatory kidney disease or severe kidney disease
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.