Inflammatory Response Clinical Trial
Official title:
Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility | Inclusion Criteria: - Outpatients who meet the diagnostic criteria for TS; - Haven't taken any drugs that affect the efficacy evaluation, such as antipsychotic drugs or traditional Chinese medicines with similar effects, or have received treatment but have passed the drug washout period for more than 1 month before enrollment; - The legal guardian and the subject themselves have been informed consent, and have signed the informed consent form, agreeing to participate in this trial, and have been reviewed and approved by the Ethics Committee of Zhejiang Provincial Hospital of Traditional Chinese Medicine. Exclusion Criteria: - Any chorenia, Wilson's disease, epileptic myoclonus, drug-induced extrapyramidal symptoms and other extrapyramidal diseases; - A history of severe tics; - Any primary diseases such as cardiovascular, hepatic, renal and hematopoietic systems; - Allergic or allergic to the drug in this test; - Current taking other drugs or accept other treatments at the same time affect the evaluation of efficacy |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Zhejiang Chinese Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8 | These include motor tics, vocal tics, and social impairment scores. Among them, motor and vocal tics were divided into five items: type of tic, frequency, intensity, complexity and interference, each item was recorded as 0, 1, 2, 3, 4 and 5 points. According to the severity, the higher score is , the more severe the severity represent. In order of severity, they are scored as 0 (no effect), 10 (little difficulty), 20 (minor difficulty), 30 (significant difficulty), 40 (fairly difficult) and 50 (very difficult).The sum of motor tics score + vocal tic score + social impairment score is recorded as the total Yale score. | Baseline and Week4 and Week8 | |
Primary | Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8 | The scale includes 5 main symptoms, including frowning or blinking, opening or grinning, shaking or shrugging shoulders, shaking hands or kicking, speaking in different or obscene words, muscle twitches, yellow face or emaciation or obesity, mental fatigue or loss of appetite, difficulty concentrating or forgetfulness and insomnia, irritable temperament or temper or difficulty sitting still or restlessness at night, irregular bowel movements, tongue and pulse.
The main symptoms are scored 0, 1, 2, 3 and 4 points according to the symptoms from mild to moderate, and the secondary symptoms are scored 0, 1 and 2 points respectively according to the symptoms from mild to severe. Tongue quality (pale red 0 points, red 1 point, red 2 points). Tongue coating (0 points for moss peeling, 1 point for moss thin white, 2 points for moss white and greasy), pulse (0 points for peace, 2 points for fine/fine strings). |
Baseline and Week4 and Week8 | |
Secondary | Change from Baseline in difference in the spacing of the lantoine side | According to X-ray mouth opening images of the child before and after treatment between two groups | Baseline and Week4 and Week8 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Not yet recruiting |
NCT06434701 -
Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
|
N/A | |
Enrolling by invitation |
NCT05020210 -
Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
|
||
Completed |
NCT04084301 -
Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
|
N/A | |
Completed |
NCT04597983 -
Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists
|
N/A | |
Not yet recruiting |
NCT06016023 -
Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
|
||
Not yet recruiting |
NCT05990933 -
Role of Adrenaline in in the Inflammatory Response in Diabetes
|
N/A | |
Not yet recruiting |
NCT04608643 -
Inflammatory Markers and Cbc Indices in Severely Malnourished Children
|
||
Recruiting |
NCT01934049 -
Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
|
Phase 4 | |
Recruiting |
NCT01417923 -
The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain
|
Phase 4 | |
Terminated |
NCT01377441 -
Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia.
|
Phase 4 | |
Completed |
NCT01301079 -
Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia
|
Phase 3 | |
Terminated |
NCT00578578 -
Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels
|
Phase 4 | |
Recruiting |
NCT04611334 -
The Effects of HRV Biofeedback on Chronic Kidney Disease Patient.
|
N/A | |
Recruiting |
NCT03510702 -
SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
|
||
Completed |
NCT03445234 -
Blueberries, Bananas, Exercise Recovery
|
N/A | |
Not yet recruiting |
NCT06450704 -
Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
|
N/A | |
Not yet recruiting |
NCT05754294 -
Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
|
||
Not yet recruiting |
NCT04386525 -
Omega 3 and Ischemic Stroke; Fish Oil as an Option
|
Phase 4 | |
Completed |
NCT04864600 -
CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles
|
N/A |