Food allergy
Conditions
Interventions
Intervention group:Shiwu-Tuomin-Decoction
Control group:Placebo
Sponsors
National Institute of TCM Constitution and Preventive Medicine Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for food allergy; (2) Meeting the diagnostic criteria for inherited special constitution in Traditional Chinese Medicine (TCM); (3) Either gender aged 3-6 years (inclusive); (4) Stable symptoms in all organ systems (skin/mucosa respiratory digestive nervous and circulatory systems) without medication requirement or where use of relief medications would not affect efficacy evaluation; (5) No use of any food allergy-related therapeutic drugs within 2 weeks prior to diagnosis; (6) Written informed consent obtained from parents or legal guardians.
Exclusion criteria
Exclusion criteria: (1) History of life-threatening food allergy reactions (e.g. anaphylactic shock syncope) or other food allergy symptoms (e.g. asthma abdominal pain vomiting dyspnea) that significantly impair daily life quality; (2) Requiring ongoing medication for symptom control in any organ system (skin/mucosa respiratory digestive nervous or circulatory systems) within 2 weeks prior to enrollment which may interfere with efficacy evaluation; (3) Symptoms attributable to other diseases (e.g. respiratory digestive or hematologic disorders); (4) Comorbidities including inflammatory bowel conditions indwelling catheters gastrostomy immunocompromised status post-cardiac/GI surgery critical illness or conditions requiring prolonged hospitalization; (5) Known hypersensitivity to any component of the investigational product; (6) Severe primary diseases affecting major organs (cardiac hepatic renal digestive or hematopoietic systems); (7) Inability to cooperate or participation in other drug trials within 1 month prior to screening; (8) Investigator-determined ineligibility for any clinical reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Desensitization rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Consortium for Food Allergy Research Systemic Allergic Reaction Grading System;Fecal Characteristics Evaluation;Serum Allergen-Specific Immunoglobulin E Testing;Physical Growth Level;Medication Scoring;Maximum tolerated dose in a single open food challenge;Time to Recurrence;Skin prick test;Total cumulative tolerated dose in a single open food challenge;Traditional Chinese Medicine Constitution Scoring;Childrens Sleep Habits Questionnaire;Serum Allergen-Specific Immunoglobulin G4 Testing; | — |
Countries
China
Contacts
Public ContactQi Wang
National Institute of TCM Constitution and Preventive Treatment of Disease Wangqi Academy of Beijing University of Chinese Medicine
Outcome results
None listed