Functional Dyspepsia
Conditions
Interventions
Experimental Group:Take Shenqi Oral Liquid, 1 vial each time, twice daily, for 4 weeks.
Control Group:Take shenqi oral solution placebo, 10 mL once, twice daily, for 4 weeks.
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Participants who meet the Rome IV diagnostic criteria for functional dyspepsia; 2. Participants for whom Rome IV recommends a severity score of at least =2 points for FD symptoms; 3. Participants who meet the diagnostic criteria for Qi deficiency syndrome; 4. Endoscopic findings should show no abnormalities or chronic gastritis, with no visible erosion under the endoscope, and pathological examination should show no significant atrophy, intestinal metaplasia, or dysplasia. The results of endoscopy from a Grade A tertiary hospital within the past week should be used as the reference standard. 5. Participants aged 18 to 65 years (inclusive of boundary values), with no gender restrictions; 6. Participants with good compliance, willing to cooperate with this study, able to accept related treatments, and undergo various physical and chemical examinations; 7. Participants who are fully informed, agree to participate in this clinical trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. One of the four main symptoms of FD is classified as extremely severe, or only one main symptom is present and classified as mild; 2. Dyspepsia caused by organic diseases of the digestive system, such as peptic ulcers, gastroesophageal reflux disease, erosive gastritis (Grade 2 or above), atrophic gastritis, digestive tract tumors, digestive tract bleeding, hepatobiliary and pancreatic diseases, intestinal obstruction, inflammatory bowel disease, etc.; 3. Systemic diseases affecting gastrointestinal motility, such as diabetes, chronic renal insufficiency, connective tissue diseases, neurological disorders, etc.; 4. Patients with severe primary diseases of the heart, brain, liver, lungs, kidneys, blood, or other conditions that significantly impact survival; 5. History of abdominal surgery (except appendectomy and cesarean section); 6. Pregnant or breastfeeding women, or patients with plans for pregnancy in the near future; 7. Abnormal liver and kidney function as indicated by laboratory tests: ALT, AST >1.5 times the upper limit of normal, SCr > upper limit of normal; 8. Patients with disabilities as defined by law (blindness, deafness, mutism, intellectual disabilities, mental disorders, physical disabilities); 9. Suspected or confirmed history of alcohol or substance abuse; 10. Participants who have taken part in other drug clinical trials within the past three months, or who have taken medications in the week prior to the trial that may affect the assessment of the trial drug's efficacy (e.g., acid-suppressing/antacid drugs, non-steroidal anti-inflammatory drugs, anticholinergic drugs, glucocorticoids, antidepressants, etc.); 11. Allergic constitution, such as a history of allergy to two or more drugs or foods, or known allergy to components of the trial drug; 12. Other conditions, as judged by the investigator, that may reduce the likelihood of enrollment or complicate the enrollment process, such as frequent changes in work environment that may lead to loss to follow-up; 13. Other participants deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive Assessment of Primary Symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Symptom Response Rate;Single Symptom Efficacy Evaluation;7-point Likert scale;Evaluation of therapeutic effects on TCM syndromes;Therapeutic effect of single symptoms in Qi deficiency syndrome;FD Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactLi Hui Zhen
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed