Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

Table 3 Inclusion and exclusion criteria

Inclusion criteria

1 Age 18-70 yr, Chinese reading and writing ability

2 Meeting the Rome III diagnostic criteria for PDS

3 Having the symptom of “spleen-deficiency and Qi-stagnation”, “spleen-deficiency and damp-obstruction”, “spleen-Yang deficiency”.

4 Signing the informed consent form

Exclusion criteria

1 Combined with GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa or suspicious malignant lesion

2 Having overlap syndrome combined with gastroesophageal reflux disease or irritable bowel syndrome

3 Having alarm symptoms (weight loss, black or tar stool, dysphagia, etc.)

4 Having serious structural disease (disease of heart, lung, liver or kidney) or mental illness

5 History of surgery related with the gastrointestinal tract, except for appendectomy more than six months ago

6 Taking drugs which may affect the gastrointestinal tract, such as nonsteroidal anti-inflammatory drugs and aspirin

7 Allergy to the experimental medication

8 Difficulties in attending the trial (paralysis, serious mental illness, dementia, renal diseases, stroke, coronary atherosclerotic heart diseases, diabetes or mental diseases, illiteracy, etc.)

9 Pregnant or breastfeeding

10 Refusing to sign the informed consent form