Functional dyspepsia with upper abdominal pain syndrome accompanied by anxiety
Conditions
Interventions
Experimental Group:Qizhi Weitong Tablets, to be taken orally, 3 tablets (0.5g/tablet) each time, three times daily, for 4 consecutive weeks.
Control group:Qizhi Weitong Tablet Simulator, administered orally, 3 tablets each time, 3 times daily (0.5g/tablet). Continue the treatment for 4 consecutive weeks.
Sponsors
Wangjing Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the Western medicine diagnostic criteria for epigastric pain syndrome type functional dyspepsia, as well as the traditional Chinese medicine diagnostic criteria, with or without post-meal discomfort syndrome; 2. The subjects are in an anxious state (HAMA score 7 = score = 18 years old and <= 65 years old, gender not limited; 4. Voluntary participation in this clinical trial and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with combined gastric and duodenal ulcers, with mucosal erosion and bleeding observed under gastroscopy, and with pathological findings suggesting gastric mucosal atrophy, intestinal metaplasia or dysplasia; 2. Positive for Hp infection (positive result in any one of bacterial culture, histological examination, urea breath test, rapid urease test and fecal antigen detection); 3. Patients with gastroesophageal reflux disease (with typical heartburn and reflux symptoms); 4. Organic lesions of the digestive system detected by abdominal B-ultrasound (such as cholecystitis, gallstones, chronic pancreatitis, etc., liver, gallbladder, spleen, and pancreas diseases); 5. Patients with a history of gastric/abdominal surgery (except cesarean section or appendectomy); 6. Patients with connective tissue diseases, diabetes and other endocrine metabolic diseases, menopause syndrome; or having severe primary cardiovascular diseases, liver diseases (ALT > 1.5 times the normal value, and/or AST > 1.5 times the normal value), kidney diseases, hematological diseases, lung diseases; or other serious diseases that affect their survival, such as tumors or AIDS; 7. Patients with a previous history of mental disorders or anxiety and depression caused by the use of psychotropic substances, and related family history; 8. Patients with allergic constitution or allergic to the components of this preparation; 9. Patients currently participating in or within 4 weeks of participating in other drug clinical trials; 10. Pregnant women, lactating women or patients planning pregnancy; 11. Patients suspected or confirmed to have a history of alcohol or drug abuse; 12. Or other conditions that the investigator deems to reduce the possibility of enrollment or make the enrollment process complicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Symptom Response Rate (7-point Likert Scale); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale;Primary Symptom Score;Nepean Dyspepsia Index Score;TCM Syndrome Score;Overall Symptom Response Rate (7-point Likert Scale); | — |
Countries
China
Contacts
Public ContactWei Wei
Wangjing Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed