Pediatric Functional Dyspepsia
Conditions
Interventions
Experimental Group:For children aged 4-6 years: Children's Jianpi Granules, 2.5 g per sachet, 1 sachet per dose, 3 times a day, taken orally 30 minutes before meals. For children aged 7-12 years: Chi
Control Group:For children aged 4 to 6 years: Pediatric Jianpi Granule Simulant, 2.5g per sachet, 1 sachet per dose, three times a day, taken orally 30 minutes before meals. For children aged 7 to 12
Sponsors
Shanghai City Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for functional dyspepsia in children and the PDS subtype diagnostic criteria; (2) Meets the diagnostic criteria for spleen deficiency with food stagnation in traditional Chinese medicine; (3) During the run-in period, the main symptom score on the PDS main symptom scale is =2 points for 1 or more main symptoms; (4) Age is between 4 and 12 years old (inclusive); (5) For children under 8 years old, the legal guardian provides informed consent and signs the informed consent form; for children 8 years old or older, both the child and the legal guardian provide informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) The child patient has comorbid irritable bowel syndrome, functional abdominal pain, functional constipation, and upper abdominal pain syndrome, among other clinical conditions; (2) The child patient had a history of prolonged improper feeding or picky eating prior to the onset of the disease; (3) The child patient has comorbid organic diseases of the digestive system, or digestive tract symptoms caused by other related diseases; (4) The child patient has a history of gastric or abdominal surgery (appendectomy excluded); (5) The child patient has comorbid severe primary diseases of the heart, liver, kidneys, or hematopoietic system, severe pulmonary infections, or other life-threatening severe diseases (e.g., malignant tumors); (6) The child patient needs to take non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, or antidepressants during the study period, which may cause symptoms of indigestion; (7) The child patient has used Chinese medicine (including Chinese herbal decoctions), Western medicine, gut microbiota agents, digestive health supplements, or acupuncture, massage, and patch therapy for the treatment of functional dyspepsia during the run-in period; (8) The child patient has an allergy to the investigational drug or its components; (9) The child patient has a history of cranial trauma within the past 3 months; (10) The child patient has participated in other clinical trials within the past 1 month; (11) The child patient has elevated liver function (AST, ALT) or renal function (Scr) levels exceeding the upper limit of normal values; (12) Other conditions or circumstances, as judged by the investigator, that may reduce the likelihood of enrollment or complicate the enrollment process, such as unstable living conditions, unstable emotions of the child or family members, or transportation difficulties, which may lead to non-compliance with the protocol or affect the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total score of main symptoms (postprandial bloating discomfort or early satiety) in PDS (Postprandial Distress Syndrome) compared to baseline decrease.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The total score of the main symptoms (post-meal bloating discomfort or early satiety) in PDS (Postprandial Distress Syndrome) decreased compared to the baseline value.;Response Rate to the Efficacy of Postprandial Distress Syndrome (PDS);Disappearance rate of single clinical symptoms in PDS (Postprandial Distress Syndrome);The decrease in the total score of the Traditional Chinese Medicine (TCM) syndrome scale compared to baseline.;The efficacy rate of traditional Chinese medicine syndromes;The disappearance rate of individual symptoms.; | — |
Countries
China
Contacts
Public ContactXue Zheng
Shanghai City Hospital of Traditional Chinese Medicine
Outcome results
None listed