Functional Dyspepsia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for this trial: (1) Aged between 18-65 years, with no restriction on gender; (2) Subjects in an anxious state (HADS-A score =8) and without depressive state (HADS-D score =8); (3) Meet the diagnostic criteria for functional dyspepsia PDS in Western medicine and the diagnostic criteria for spleen-stomach damp-heat syndrome in traditional Chinese medicine; (4) Have not received any Chinese or Western internal medications or external treatments for functional dyspepsia within at least 15 days prior to treatment, and have not participated in other clinical trials; (5) Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: If a subject meets any of the following exclusion criteria, they are not eligible to participate in this trial: 1. Organic Diseases: Patients confirmed to have clear organic diseases (e.g., gastric ulcers, gastric cancer, gallbladder diseases, etc.) through endoscopy, ultrasound, CT, or other examinations. 2. Severe Diabetes Mellitus, Chronic Obstructive Pulmonary Disease (COPD), Cirrhosis, Chronic Kidney Disease, Severe Cardiovascular Diseases (e.g., hypertension, angina pectoris), or other chronic cerebrocardiovascular diseases. 3. Advanced malignant tumors or other severe wasting diseases, with a tendency to develop infections or bleeding. 4. HADS-D score =8 points or HADS-D score > HADS-A score. 5. Patients where the onset of anxiety or depression is persistent and primary, with no significant correlation to the occurrence, progression, or alleviation of symptoms associated with functional dyspepsia. 6. Patients where the onset of anxiety or depression is due to drug withdrawal reactions. 7. Severe mental disorders, such as depression, schizophrenia, or other mental illnesses that may affect mood or cognitive functions. 8. History of long-term drug abuse or dependence, especially sedatives, opioids, or antidepressants. 9. Pregnant or breastfeeding women: Due to potential effects of drugs and treatments on the fetus or infant, pregnant or breastfeeding women are typically excluded. 10. History of recent digestive system surgery, particularly gastrointestinal surgery, as this may impact gastrointestinal function. 11. Patients who have undergone other treatment methods in the past two weeks, which may affect the assessment of the therapeutic effects of this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Main Symptom Score;Anxiety and Depression State Evaluation;International Physical Activity Questionnaire;Short-form Nepean Dyspesia Index; Perceived Stress Scale; | — |
Primary
| Measure | Time frame |
|---|---|
| Overall Symptom Response Rate; | — |
Countries
China
Contacts
Beijing University of Chinese Medicine