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

Exclusion Criteria

• •1. Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening;
• •2. Gastric mucosal erythema grade II or above, erosion is bulge or grade II or above, or accompanied by bleeding, bile reflux, ≥ 3 inflammatory polyps and other manifestations, or combined with pathological diagnosis of chronic atrophic gastritis, hyperplastic polyps, glandular polyps, etc.; or those who have been clearly diagnosed with dyspepsia caused by organic diseases of the digestive system, such as digestive tract tumors, hepatobiliary and pancreatic diseases, inflammatory bowel diseases, etc.; or those who have other diseases that affect the evaluation of dyspepsia-related symptoms in the past, such as reflux esophagitis, peptic ulcer, gastrointestinal bleeding, intestinal obstruction, etc.;
• •3. Those who have been diagnosed with systemic diseases that seriously affect the function of the digestive tract, such as hyperthyroidism or hypothyroidism, diabetes, chronic renal insufficiency, connective tissue diseases, etc.;
• •4. Patients with severe cardiovascular and cerebrovascular, liver, lung, kidney, blood or systemic diseases that affect their survival; or patients with severe mental illness in the past, such as moderate or severe depression/anxiety/bipolar disorder, etc.;
• •5. Those who have a history of major abdominal surgery in the past, which may affect gastrointestinal function (except for appendectomy, cesarean section, endoscopic colon polyp resection and other surgeries that do not affect digestive function);
• •6. Patients with abnormal liver function (ALT or AST \>1.5 times the upper limit of normal) or abnormal renal function test (Cr\> upper limit of normal);
• •7. Glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥7mmol/L during the screening period;
• •8. Use of drugs or treatments that may have an impact on the effectiveness assessment of the trial drug within 2 weeks before screening (such as acid/antacids, gastrointestinal motility drugs, digestive enzymes, gastric mucosal protectors, antiemetics, antispasmodics, macrolide antimicrobials, azole antifungals, non-steroidal anti-inflammatory drugs, glucocorticoids, anti-anxiety and depressants, analgesics, sedatives; as well as traditional Chinese medicine decoctions, proprietary Chinese medicines and acupuncture treatments for the treatment of functional dyspepsia, etc.);
• •9. Pregnant and lactating women, who have a birth plan within one month after enrollment and the end of the trial;
• •10. Those who suspect or have a history of alcohol or drug abuse;
• •11. Participated in other clinical trials within 1 month before screening;
• •12. Those who are suspected or known to be allergic to the ingredients of this medicine;
• •13. According to the judgment of the investigator, it is not suitable to participate in this study.