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. - CGB_1109

CGBS GbR0 个研究点目标入组 100 人开始时间: 2023年7月24日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

发起方

CGBS GbR