Objectives of Study:
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Primary objective: To evaluate the efficacy and safety of Lianxiaxiaopi Keli in the treatment of functional dyspepsia (cold-heat complicated syndrome), so as to provide basis for later clinical trials.
Exploratory objective: To explore the changes of endogenous substances and immune indexes in vivo before and after taking medicine, to explain the mechanism of drug action through omics research methods (including metabonomics, proteomics, one or more omics studies in Immunology) and system biology methods, and to find potential clinical biomarkers for exploratory subgroup analysis of clinical trials.
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Inclusion criteria
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(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.
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Exclusion criteria:
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(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.
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