Study of 4-MUST Tablets for Treating Chronic Cholecystitis and Biliary Dyskinesia in Adults Aged 18 to 70

What this Trial Is About

Researchers are evaluating the drug 4-MUST to understand its effectiveness, safety, and tolerability in treating patients with chronic cholecystitis and biliary dyskinesia. This study compares different doses of 4-MUST with a placebo to see how well the drug reduces upper abdominal pain and gastrointestinal symptoms. The trial is a phase 2, prospective, randomized, double-blind, placebo-controlled study designed to provide detailed insight into the drugs impact on these digestive conditions. Participants will be randomly assigned to one of four groups. One group receives 1 tablet of 4-MUST 128 mg plus 2 placebo tablets three times daily, another receives 2 tablets of 4-MUST 256 mg plus 1 placebo tablet three times daily, a third group takes 3 tablets of 4-MUST 384 mg three times daily, and the last group receives 3 placebo tablets three times daily. The treatment lasts for 29 days, with doses given three times a day, followed by assessment and monitoring. During the study, participants will undergo regular evaluations including pain measurement using a Visual Analog Scale VAS, gastrointestinal symptom rating via questionnaires, and quality of life assessments with the SF-36 questionnaire. Safety will be monitored through adverse event tracking, physical examinations, vital signs, laboratory tests, and electrocardiograms at multiple time points throughout the 29-day period and up to day 36. These thorough assessments aim to capture the drugs effects and tolerability over the course of treatment.

Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia