protocolSection identificationModule nctId: NCT06379373, orgStudyIdInfo id: 2023-KLS-190-02, briefTitle: Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Zhejiang Chinese Medical University, class: OTHER, descriptionModule briefSummary: Tourette syndrome is a refractory type of tic disorder. Previous clinical studies have confirmed that Tuina has a good effect on TS, but the mechanism of action is still uncertain. Studies have found that the pathogenesis of TS may be related to immune factors, and patients will accompanied by the overflow of inflammatory factors such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) during the onset of the disease. Other studies have found that the serum levels of IgG1, IgG2, IgG3, IgG4, IgGM, IgGA, IgGE, complement C3 and complement C4 are closely related to the pathogenesis of TS, and the abnormal humoral immune response mediated by food intolerance has an important impact on the pathogenesis of mental illness in children. The immune system plays a very complex role in TS. Based on this, we hypothesized that there may be differences in serum humoral immune effector levels between children with TS and healthy children, whether these differences are related to the consumption of certain allergenic foods or not, and so does Tuina spinal balancing can improve the clinical symptoms of children with TS by changing the levels of inflammatory and immune factors in peripheral serum. This study studied the peripheral mechanism of humoral immune effector mediated by Tourette syndrome and the intervention effect of Tuina through comprehensive scale analysis and advanced laboratory technology, which will provide a scientific theoretical basis and a safe and effective method for the treatment of multiple tics, and will have broad application prospects., conditionsModule conditions: Tourette Syndrome in Children, conditions: Food Intolerance, conditions: Inflammatory Response, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: According to the order of enrollment, the random number table method was used to divide the massage spinal manipulation+ placebo group (oral placebo, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d), relaxation manipulation+ western medicine group (oral Typride tablets, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d) for 2 consecutive weeks. Both groups were intervened for 2 courses. The observation time points were 2 weeks, 4 weeks, and 3 months before treatment and after treatment., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Spine manipulation; westren medicine, outcomesModule primaryOutcomes measure: Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8, primaryOutcomes measure: Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8, secondaryOutcomes measure: Change from Baseline in difference in the spacing of the lantoine side, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Zhejiang Chinese Medical University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, contacts name: xiao Li, Doc., role: CONTACT, phone: 0571-87072953, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False