functional dyspepsia
Conditions
Interventions
Sponsors
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) The age is 18-65 years old (including the boundary value), and the gender is not limited; (2) They were in accordance with the diagnostic criteria of functional dyspepsia of Western Medicine (Rome IV); (3) According to the syndrome differentiation standard of cold-heat complicated syndrome; (4) In the screening period, the NRS score of at least one symptom of functional dyspepsia (postprandial fullness and discomfort, early satiety, mid upper abdominal pain, mid upper abdominal burning sensation) was >= 4; (5) In the lead-in period, the average NRS score of at least one symptom of functional dyspepsia (postprandial discomfort, early satiety, mid upper abdominal pain, mid upper abdominal burning) was >= 4; (6) No organic abnormality was found in gastroscopy (except chronic non atrophic gastritis); (7) Voluntarily participate in clinical trials, sign informed consent, and understand and follow the research procedures.
Exclusion criteria
Exclusion criteria: (1) Previous diagnosis of dyspepsia caused by organic diseases of digestive system, such as reflux esophagitis, atrophic gastritis, gastrointestinal tumor, hepatobiliary pancreatic disease, inflammatory bowel disease, etc; (2) Patients with diseases affecting the evaluation of digestive symptoms, such as peptic ulcer, intestinal obstruction, erosive gastritis (above grade 2), gastrointestinal bleeding, chronic non atrophic gastritis with polyps; (3) Patients with systemic diseases that seriously affect the digestive tract function, such as hyperthyroidism or hypothyroidism, diabetes, chronic renal insufficiency, connective tissue disease, etc; (4) Patients with severe cardiovascular, cerebrovascular, liver, lung, kidney, blood or systemic diseases affecting their survival; (5) Previous history of abdominal surgery (except appendectomy and cesarean section); (6) The liver function or renal function examination was abnormal and had clinical significance, and the researcher judged that it was not suitable to participate in the trial; (7) The patients who were previously diagnosed with hypertension and had poor blood pressure control (systolic blood pressure >= 140 mmHg, diastolic blood pressure >= 90 mmHg after taking antihypertensive drugs) or with complications; (8) During the trial, we can not stop taking drugs that may affect the effectiveness evaluation of the trial drugs (such as acid suppressor / antacids, non steroidal anti-inflammatory drugs, anticholinergic drugs, glucocorticoids, antidepressants, etc.); (9) Pregnant and lactating women who have fertility planning within 3 months after enrollment to the end of the trial; (10) Suspected or with a history of alcohol or drug abuse; (11) Participated in other clinical trials within one month before screening; (12) Allergic constitution, such as those with a history of allergy to two or more drugs or food, or those known to be allergic to the ingredients of this drug; (13) According to the judgment of the researcher, it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of dyspepsia symptoms, 8 weeks;Response rate of dyspepsia symptoms, 4/6 weeks;Response rate of postprandial discomfort syndrome, 4/6/8 weeks;Response rate of upper abdominal pain syndrome, 4/6/8 weeks;Dyspepsia symptom score, 2/4/6/8 weeks;Disappearance rate of single dyspepsia symptom, 4/8 weeks;Single symptom of TCM Syndrome, 2/4/6/8 weeks; | — |
Countries
China
Contacts
Public ContactFengpeimin
Affiliated hospital of Chengdu University of Triditional Chinese Medicine
Outcome results
None listed