Functional dyspepsia
Conditions
Interventions
Experimental group:XiangShaHeWeiYin
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: Only those who meet all of the following conditions can be selected for the research: (1) It meets the Western medical diagnostic criteria for functional dyspepsia (FD) in infants and children and the TCM syndrome diagnosis criteria for "liver-stomach disharmony syndrome" of functional dyspepsia. (2) Age: 1 to 3/4 to 14 years old (=14 years old) with no gender restrictions; (3) The informed consent of the legal guardian of the subject must be obtained and the informed consent form must be voluntarily signed. When the subjects can make the decision to participate in the clinical trial the consent of the subjects themselves must also be obtained. (4) During the 2-week screening period no relevant drugs for treating dyspepsia were used good dietary habits were established but the symptoms of functional dyspepsia (FD) still existed. Those who do not meet any of the above conditions shall not be selected as subjects.
Exclusion criteria
Exclusion criteria: Studies that meet any of the following criteria need to be excluded: (1) Indigestion caused by organic diseases such as acute and chronic gastroenteritis peptic ulcers history of gastrointestinal surgery acute and chronic hepatitis anorexia nervosa and anorexia caused by certain drugs; (2) Concurrent treatment may cause constipation or enhanced gastrointestinal motility. (3) Moderate to severe malnutrition; (4) There are serious primary diseases in the cardiovascular nervous respiratory liver and gallbladder urinary systems etc. (5) Mental disorders intellectual disabilities and/or communication disorders; (6) Allergic to the components of XiangShaHeWeiYin and Mosapride citrate oral solution; (7) Participated in clinical trials within the past 12 weeks; (8) Those whom the researcher deems unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total effective rate at 2 weeks after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-targeted metabolomics;Recurrence situation;Changes in electrogastrogram;The degree of improvement in weight and meal time;Niping dyspepsia index scale, quality of life evaluation;The degree of reduction in the total symptom score, individual symptom score and TCM syndrome score at each follow-up time point compared with the baseline;The disappearance rate and apparent efficiency of individual clinical symptoms at 1 week and 2 weeks after randomization.;Therapeutic effects of syndromes in traditional Chinese medicine;Gastrointestinal hormone levels;Oral/intestinal microbiota analysis; | — |
Countries
China
Contacts
Public Contactwang xuefeng
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed