Functional Dyspepsia
Conditions
Interventions
Experimental Group:Pediatric Diarrhea Remedy Patch
Control Group:Erxie Kang Patch Simulant
Sponsors
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: Subjects may be included in the study only if they meet all of the following criteria: (1) Meets the diagnostic criteria for pediatric/child FD in Western medicine and the diagnostic criteria for syndrome differentiation in traditional Chinese medicine; (2) Aged 1 to 14 years (=14 years), with no gender restrictions; (3) Agrees to cooperate with medication and accept assessments in accordance with the requirements of the trial protocol; (4) Must obtain written informed consent from the legal guardian of the subject, who must voluntarily sign the informed consent form; when the subject is capable of making the decision to participate in the clinical trial, the subject's own consent must also be obtained. Subjects who do not meet one or more of the above criteria shall not be included in the study.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must be excluded: (1) Dyspepsia caused by organic diseases, such as acute or chronic gastritis and enteritis, peptic ulcers, history of gastrointestinal surgery, acute or chronic hepatitis, anorexia nervosa, or anorexia caused by certain medications; (2) Concurrent treatments that may cause constipation or enhanced gastrointestinal motility; (3) Moderate to severe malnutrition; (4) Severe primary diseases in cardiovascular, nervous, respiratory, hepatobiliary, or urinary systems; (5) Mental disorders, intellectual disabilities, and/or communication disorders; (6) Known allergy to the investigational drug or its components, or a history of allergic constitution; (7) Participation in other clinical trials within the past 12 weeks; (8) Subjects deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weekly abdominal pain episode days;Clinical single symptom disappearance rate and response rate;TCM Syndrome Score;Niping Dyspepsia Index Scale;The improvement level of weight and meal timing;Recurrence situation; | — |
Countries
China
Contacts
Public ContactWANG XUEFENG
No. 33 Beiling Street, Shenyang City, Liaoning Province
Outcome results
None listed