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Table 1 Inclusion, exclusion and spleen-deficiency and qi-stagnation syndrome diagnostic criteria

From: Efficacy of modified LiuJunZi decoction on functional dyspepsia of spleen-deficiency and qi-stagnation syndrome: a randomized controlled trial

Inclusion criteria

1. Patients who meet the Rome III diagnosis standard of functional dyspepsia.

2. Patients who have Spleen-deficiency and qi-stagnation syndrome.

3. Patients aged 18 to 65 without gender limitation.

4. Signed the informed consent.

Exclusion criteria

1. Patients who combined with GI ulcer, erosive gastritis, atrophic gastritis, severe dysplasia of gastric mucosa or suspicious malignant lesion.

2. Patients who have overlap syndrome combined with gastroesophageal reflux disease or irritable bowel syndrome.

3. Patients whose syndrome is difficult to differentiate.

4. Patients who have connective tissue diseases, diabetes or other endocrine disease, climacteric syndrome, or severe diseases in heart, liver, lung, kidney, blood.

5. Pregnant or lactating women. Disabled people.

6. Patients with history of alcoholic or drug abuse.

7. Patients who have allergic constitution or known to be allergic to the drug used in this trial.

8. Patients who are involved in other trials.

9. Patients with poor compliance or other reasons that the researcher considered not to be appropriate to participate in this trial.

10. Patients with severe depression and have suicidal tendency.

Spleen-deficiency and qi-stagnation syndrome diagnostic criteria

The spleen-deficiency and qi-stagnation syndrome is defined as having the main symptoms and at least two of the accompanying symptoms, as well as pale tongue with whitish tongue coating and deep and thready pulse. The main symptoms include epigastric stuffiness and fullness, and asthenia. While the accompanying symptoms include epigastric stuffiness and fullness aggravated after meal, epigastric pain, decreased appetite, belching and acid regurgitation, fullness and discomfort in chest and hypochondrium, nausea and vomiting, and constipation or loose stool.