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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying adult participants with chronic kidney disease CKD who have high protein levels in their urine. The study aims to evaluate the effects of a combination of two drugs, zibotentan and dapagliflozin, compared to dapagliflozin alone. This Phase II, multicenter, randomized, double-blind study also assesses safety and tolerability of these treatments alongside standard care, including participants with or without type 2 diabetes mellitus. Participants not already using SGLT2 inhibitors will first receive dapagliflozin alone daily for 28 days during a run-in period. Then, all participants enter a 12-week double-blind treatment phase where they receive either the fixed-dose combination of zibotentan and dapagliflozin or dapagliflozin alone daily, with doses adjusted based on kidney function eGFR. After this period, participants stop the blinded treatment and continue open-label dapagliflozin alone for 4 weeks for safety follow-up. During the study, participants will have their urinary albumin to creatinine ratio UACR measured to evaluate kidney function at 12 weeks. Other assessments include urinary protein to creatinine ratio, blood pressure changes, and monitoring of any adverse events from the start of treatment through a follow-up visit 18 weeks after enrollment. The total participation includes screening, run-in, treatment, and safety follow-up periods, providing detailed data on the treatment effects and safety profile.

Age: 18Years +All GendersPhase 2
15 locations
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Actively Recruiting

Researchers are evaluating Raphamin in adults aged 18 to 64 years who have acute bronchitis symptoms lasting less than 72 hours. This randomized, double-blind, placebo-controlled phase 3 trial aims to determine if Raphamin can speed up symptom resolution, reduce disease severity, and prevent complications requiring antibiotics compared to placebo. The study includes both men and women during the seasonal period of acute respiratory viral infections. Participants are randomly assigned to receive either Raphamin or a placebo following a specific oral dosing schedule for 5 days. On the first day, participants take 8 tablets of Raphamin or placebo one tablet every 30 minutes for the first 2 hours total of 5 tablets, then one tablet three times spaced evenly throughout the day. From day 2 onwards, one tablet is taken three times daily. The study uses an electronic patient diary to record daily symptoms, and face-to-face visits are scheduled on days 1, 4, and 7, with a phone visit on day 14. Throughout the study, participants undergo physical exams, vital sign monitoring, pulse oximetry, and laboratory tests including blood counts and PCR for respiratory viruses. Symptom severity is assessed by the Bronchitis Severity Scale and the Integrative Medicine Outcome Scale. Quality of life is evaluated using the EQ-5D instrument. Safety is monitored through recording adverse events and any use of antibacterial medications or hospitalizations. The total duration of participation includes treatment and follow-up over 14 days.

Age: 18Years - 64YearsAll GendersPhase 3
33 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of Raphamin in treating acute rhinosinusitis in adult patients aged 18 to 75 years. This multicenter, double-blind, placebo-controlled, randomized clinical trial focuses on adults experiencing symptoms within 48 hours of disease onset during the seasonal peak of acute respiratory viral infections. The study aims to compare Raphamin against placebo in improving symptoms and quality of life. Participants will be randomly assigned to one of two groups at the first visit. One group receives Raphamin tablets dissolved in the mouth following a specific dosing schedule over 5 days, starting with multiple doses on day 1 and three times daily thereafter. The other group receives a placebo on the same schedule. The study includes a treatment period of 5 days and follow-up visits up to 14 days. Participants will attend three visits on days 1, 4, and 7, either at a medical center or at home, with a phone visit on day 14. They will complete symptom severity scales and quality of life questionnaires, record daily temperature and symptoms in an electronic diary, and report any worsening condition or adverse events. Researchers will monitor symptom improvement, safety, antibiotic use, hospitalizations, and vital signs throughout the study and follow-up period.

Age: 18Years - 75YearsAll GendersPhase 3
44 locations