International Clinical Study of Zhizhu Kuanzhong Capsule

Inclusion Criteria:

1. Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distresssyndrome;
2. • At least 3 days during the one-week run-in period with VAS score ≥ 4 for majorsymptoms (at least one of postprandial fullness discomfort and early satiety) .
3. Age between 18 and 65 years old (including 18 and 65 years old), male or female,outpatients;
4. **Be able to discontinue prohibited medications that may affect the evaluation of theeffectiveness, such as acid inhibition/antacids, prokinetic agents, non-steroidalanti-inflammatory drugs, anticholinergic agents, glucocorticoids, and therapeuticmedication for H. pylori eradication.
5. Each subject is informed and voluntarily signed the informed consent form(ICF).

• Subjects who entered the one-week run-in period are self-rated on the VisualAnalogue Score (VAS) for the degree of discomfort with both symptoms ofpostprandial fullness and early fullness, with subjects indicating the degree ofdiscomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort"and 10- "Extreme Severe or Extreme Discomfort"at its head and tail, respectively. Therating was made once a day and 7 days a week with scores of 0 to 10.
• A 2-week wash-out period is required for patients taking prohibitedmedications prior to screening.

Exclusion Criteria:

1. Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 orhigher), moderate to severe atrophic gastritis, dysplasia, or other organgastrointestinal disease.
2. Patients with a history of abdominal surgery (except for appendectomy and cesareansection).
3. Patients with immune system defects (such as leukaemia or cancer), or those who havebeen administered immunosuppressive agents or glucocorticoids within the past 3months.
4. Patients who combined severe cardiac and pulmonary insufficiency, insufficiency ofliver (ALT/AST > 1.5 times the upper limit of the normal value) and kidneyinsufficiency (BUN/Serum Creatinine > the upper limit of the normal value), abnormalof endocrine system( such as diabetes and thyroid dysfunction), abnormal hematopoieticsystem, and iron deficiency anemia as indicated on hematological examination.
5. Patients with severe anxiety and depression.
6. Patients with psychosis and mental retardation as well as language disorder precludingthe ability of filling scales or recording symptoms.
7. Pregnant (a female of childbearing potential with a positive pregnancy test) orlactating females; or patients of childbearing potential without effectivecontraception.
8. Patients who are known to be allergic to the ingredients of this drug.
9. Patients who are suspected to have or indeed have a history of alcohol or drug abuse.
10. Patients who have participated in a clinical trial in the past 3 months.
11. Patients who are deemed by the investigator as being not suitable for participation inthe clinical trial.