Functional dyspepsia
Conditions
Interventions
Test group:Kaiwei Zhitong plaste
control group:Appetizer and Pain Relief Patch Simulator
Sponsors
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: Only those who meet all the following conditions can be selected: (1) It meets the western medicine diagnostic criteria and TCM syndrome diagnostic criteria of FD in children; (2) The age ranged from 1 to 14 years old (= 14 years old) with no sex restriction; (3) Agree to cooperate with the medication and accept the evaluation according to the requirements of the test plan; (4) The informed consent of the legal guardian of the subject must be obtained and the informed consent form must be signed voluntarily; When the subject can make the decision to participate in the clinical trial the consent of the subject must also be obtained. Those who do not meet one of the above conditions shall not be selected as subjects.
Exclusion criteria
Exclusion criteria: Those who meet any of the following criteria shall be excluded: (1) Dyspepsia caused by organic diseases such as acute and chronic gastroenteritis peptic ulcer gastrointestinal surgery history acute and chronic hepatitis anorexia nervosa anorexia caused by some drugs; (2) At the same time the treatment can cause constipation or gastrointestinal motility enhancement; (3) Moderate and severe malnutrition; (4) There are serious primary diseases such as cardiovascular nervous respiratory hepatobiliary and urinary system; (5) Mental intellectual and/or communication disorders; (6) Those who are clearly allergic to the test drug or its preparation ingredients or allergic constitution; (7) Participated in clinical trials in the past 12 weeks; (8) The investigator believes that it is not appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total effective rate at 2 weeks after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome efficacy;Nipin Indigestion Index Scale;Changes in Gastric Electrogram;The degree of reduction of the total symptom score each individual symptom score and TCM syndrome score from baseline at each follow-up time point;The disappearance rate and apparent efficiency of individual clinical symptoms;Untargeted metabolomics;Recurrence situation;The number of gut microbiota before and after treatment;Number of days per week with abdominal pain attacks;Gastrointestinal hormone levels;The degree of improvement in weight and eating time; | — |
Countries
China
Contacts
Public ContactWang Xuefeng
Liaoning University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed