functional dyspepsia
Conditions
Interventions
Experimental group:Shanpu Jianpi granule
Control group:Mosapride citrate solution was administered orally
Sponsors
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Functional dyspepsia in children diagnosed by western medicine; 2. Syndrome differentiation of spleen deficiency and stagnation of food; 3. Age 1-14 years old (=14 years old) no gender restriction; 4. Informed consent must be obtained from the legal guardians of the subjects and informed consent must be signed voluntarily; When a subject can make a decision to participate in a clinical trial his or her consent must also be obtained. During the 5.2-week screening period no dyspepsia-related drugs were used good dietary habits had been established and FD symptoms still existed.
Exclusion criteria
Exclusion criteria: 1. Dyspepsia caused by organic diseases such as acute and chronic gastroenteritis peptic ulcer history of gastrointestinal surgery acute and chronic hepatitis anorexia nervosa anorexia caused by some drugs; 2. Concurrent treatment may cause constipation or enhanced gastrointestinal motility; 3. Moderate and severe malnutrition; 4. Allergic to components of Shanpu-Jianpi granules or mosapride citrate oral solution; 5. Serious primary diseases of cardiovascular nervous respiratory hepatobiliary urinary system etc. 6. Mental intellectual and/or communication disorders; 7. Participants who participated in other clinical trials within 3 months before the trial; 8. Those who were deemed unsuitable to participate in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical disappearance rate and significant efficacy rate of individual symptoms;Individual symptom scores;Niping Digestive Dysfunction Index Scale;Number of gut microbiota;Total symptom scores at each follow-up time point;Non-targeted metabolomics;Traditional Chinese Medicine Syndrome Points;Recurrence situation;Gastrointestinal hormone levels;The degree of improvement in weight and dietary time;Degree of decrease in TCM evidence score relative to baseline;Changes in Gastric Electrogram; | — |
Countries
China
Contacts
Public ContactWang Xuefeng
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed