Functional dyspepsia Digestive System
Conditions
Interventions
Before starting the intervention, researchers will provide health education to the subjects and give face-to-face guidance on the usage, dosage, and precautions of rice paste. Rice paste will be distr
Sponsors
Beijing Shijitan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old with no gender restrictions 2. Meet the diagnostic criteria for functional dyspepsia in Rome III (the absence of organic dyspepsia confirmed by endoscope) 3. Normal gastroscopy results in the past 1 year, and no other organic lesions in the gastrointestinal tract 4. No mental illness (Mini Mental State Questionnaire, MMSE = 20) 5. Able to take food orally 6. Volunteered to accept intervention and signed the informed consent 7. Compliance with treatment completion and follow-up
Exclusion criteria
Exclusion criteria: 1. Severe cognitive impairment 2. Abnormal electrocardiogram 3. Organic digestive tract disease 4. History of gastrointestinal surgery 5. Diabetes 6. Malignant tumors 7. Other diseases 8. Taking traditional Chinese medicine preparations 9. Pregnancy and breast-feeding or planning to become pregnant within 6 months 10. History of allergic reactions related to Chinese medicine or rice paste 11. Impairment of liver and kidney function: 11.1 Total bilirubin, alanine aminotransferase or aspartate aminotransferase> 2 times the upper limit of normal 11.2. Serum creatinine> 2 times the upper limit of normal 12. Drugs that affect digestive function taken within the past month and during the study period: 12.1. Gastrointestinal motility drugs 12.2. Anti-Helicobacter pylori drugs 12.3. Antidepressants 12.4. Antianxiety drugs 12.5. Acid-suppressing drugs (PPIs and H2 receptor blockers) 13. A place of residence that is too far, unwilling or unable to complete the return visit 14. H. pylori positive by Carbon-13 urea breath test at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall severity of dyspepsia symptoms measured using the 7-point global overall symptom scale (GOSS) at baseline (0 day), 15th, 30th, and 60th days after treatment, and follow-up at 1 month after the expiration of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality-of-life, adverse reactions and other indicators measured using the 36-Item Short Form Survey (SF-36) at baseline (0 day), 15th, 30th, and 60th days after treatment, and follow-up at 1 month after the expiration of the intervention | — |
Countries
China
Outcome results
None listed