Phase III Study of Lianxiaxiaopi Granules for Treating Postprandial Distress Syndrome A Randomized, Double-blind, Placebo-Controlled Trial Evaluating Efficacy and Safety in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the efficacy and safety of Lianxiaxiaopi Granules in treating participants with postprandial distress syndrome, a digestive condition characterized by symptoms such as postprandial fullness, discomfort, and early satiety. This phase III, multicenter, randomized, double-blind, placebo-controlled trial aims to determine whether Lianxiaxiaopi Granules improve symptoms better than a placebo and assess its safety in affected individuals aged 18 to 65. Participants are randomly assigned to receive either Lianxiaxiaopi Granules or a placebo, taking one sachet orally three times a day for eight weeks. The study uses a quadruple-blind design, meaning participants, care providers, investigators, and outcome assessors are unaware of group assignments to ensure unbiased results. The trial focuses on symptoms of postprandial distress syndrome and traditional Chinese medicine syndrome patterns classified as intermingled cold and heat. Throughout the study, researchers evaluate participants response rates to treatment by the end of eight weeks, including changes in symptom scores and traditional Chinese medicine assessments. Safety and symptom remission are also monitored up to 12 weeks. Participants undergo screening, symptom scoring, and Helicobacter pylori testing before enrollment and follow the trial protocol with regular assessments to measure effectiveness and safety over the study period.

A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome