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

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 coldand heat miscellaneous syndromes;

4. NRS score of at least one symptom of postprandial distress syndrome (postprandialfullness, discomfort, early satiety) in the screening period and baseline period≥ 4points; and did not have moderate/severe epigastric pain syndrome (mid-epigastricburning 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/chronicsuperficial gastritis with erythema grade I and/or erosion that was flat and onlygrade I);

6. Negative Helicobacter pylori test in 13C/14C breath test during the screeningperiod;

7. Voluntarily participate in clinical trials, sign informed consent, and understandand comply with research procedures.

Exclusion Criteria:

1. Those who have undergone Helicobacter pylori eradication treatment within 6 monthsbefore 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 othermanifestations, or combined with pathological diagnosis of chronic atrophicgastritis, hyperplastic polyps, glandular polyps, etc.; or those who have beenclearly diagnosed with dyspepsia caused by organic diseases of the digestive system,such as digestive tract tumors, hepatobiliary and pancreatic diseases, inflammatorybowel diseases, etc.; or those who have other diseases that affect the evaluation ofdyspepsia-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 thefunction 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, bloodor systemic diseases that affect their survival; or patients with severe mentalillness 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 affectgastrointestinal function (except for appendectomy, cesarean section, endoscopiccolon 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 ofnormal) or abnormal renal function test (Cr> upper limit of normal);

7. Glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥7mmol/L during thescreening period;

8. Use of drugs or treatments that may have an impact on the effectiveness assessmentof 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 anddepressants, analgesics, sedatives; as well as traditional Chinese medicinedecoctions, proprietary Chinese medicines and acupuncture treatments for thetreatment of functional dyspepsia, etc.);

9. Pregnant and lactating women, who have a birth plan within one month afterenrollment 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 inthis study.