A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome
Trial Parameters
Brief Summary
The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are: 1. Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo. 2. Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome. 3. Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 65 years old (including boundary value), gender is not limited; 2. meet the diagnostic criteria for postprandial distress syndrome (Rome IV.); 3. Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes; 4. NRS score of at least one symptom of postprandial distress syndrome (postprandial fullness, discomfort, early satiety) in the screening period and baseline period≥ 4 points; and did not have moderate/severe epigastric pain syndrome (mid-epigastric burning sensation and mid-upper quadrant pain both \< 4 points); 5. Those who did not have organic abnormal changes in the results of gastroscopy (including no abnormalities in gastroscopy, chronic non-atrophic gastritis/chronic superficial gastritis with erythema grade I and/or erosion that was flat and only grade I); 6. Negative Helicobacter pylori test in 13C/14C breath test during the screening period; 7. Voluntarily participate in clinical tr