Funtional Dyspepsia
Conditions
Interventions
treatment group:Banxia Xiexin Decoction
control group:Placebo
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of Western medicine for Rome IV functional dyspepsia syndrome and the TCM diagnostic criteria for mixed syndrome of cold and heat; 2. Aged 18-65 years, gender is not limited, outpatient; 3. The gastroscopy diagnosis must be made within 6 months before the selection. The microscopic diagnosis should be no abnormality or chronic gastritis, no obvious erosion can be seen under the microscope, and there is no obvious atrophy, intestinal metaplasia or dysplasia in the pathological examination; 4. If the 13C or 14C breath test or endoscopic pathological detection of Helicobacter pylori is negative within 3 months before the enrollment, or the patient becomes negative after treatment, the 13C or 14C breath test is required within 1 month before enrollment; 5. Subjects gave informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Taking drugs that interfere with this study within 2 weeks before treatment, such as gastrointestinal related drugs such as promoting gastrointestinal motility and anti-gastric acid secretion; 2. Those with allergic constitution or multiple drug allergies, those who are allergic to Banxia Xiexin Decoction and its components; 3. Those with a history of abdominal surgery; 4. Complicated with peptic ulcer, reflux esophagitis, erosive gastritis (grade 2 or above), atrophic gastritis, gastrointestinal tumor, gastrointestinal bleeding, hepatobiliary and pancreatic diseases, indigestion caused by organic diseases of the digestive system such as intestinal obstruction and inflammatory bowel disease; 5. Patients with connective tissue diseases, diabetes and other endocrine and metabolic diseases, menopausal syndrome; patients with severe primary heart, liver, lung, kidney, blood or serious diseases that affect their survival; 6. Suspected or definite history of drug or alcohol abuse; 7. Acupuncture, massage, cupping, ear acupuncture and other non-drug treatments; 8. Patients with severe psychological disorder, mental illness or severe neurosis; patients with cognitive and language disorders; 9. Patients who are pregnant, lactating or planning to become pregnant; 10. Disabled patients specified by law (blind, deaf, dumb, intellectually disabled, physically disabled); 11. According to the judgment of the researcher, there are other circumstances that reduce the possibility of enrollment or complicate enrollment, such as frequent business trips, frequent changes in working environment and residence, which may easily lead to loss of follow-up; 12. Those who have received clinical trials of other drugs within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall symptom score of dyspepsia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Dyspepsia Quality of Life Scale;Hamilton Anxiety Scale;Hamilton Depression Scale; | — |
Countries
China
Contacts
Public ContactGeng Qi
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed