Study on the Mechanism of Pei Tu Ning Feng Tang in Alleviating Tourette Syndrome Via Functional Near-Infrared Spectroscopy (fNIRS) and the DA-MAPK-BDNF Pathway
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment..
- Who it may be relevant to
- Registry conditions: Tourette Syndrome in Children. Basic parameters: 4 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. The differences in gut microbiota composition, peripheral blood stress hormones, oxidative stress markers, cytokines, neurotransmitters, and hair cortisol concentrations were observed before and after treatment. Combined with the differences in tic-like behavioral indicators, the therapeutic efficacy of Pei Tu Ning Feng Tang was evaluated. Additionally, TS children underwent two fNIRS examinations before and after treatment to quantitatively describe the activation of brain function by Pei Tu Ning Feng Tang and to investigate its neural mechanisms against tics. Scores were assessed before and after treatment using the Yale Global Tic Severity Scale (YGTSS) and the Traditional Chinese Medicine Syndrome Score Sheet for Pediatric Tourette Syndrome (Spleen Deficiency and Liver Hyperactivity Type) to observe the efficacy of the medication.
Interventions
- Drug Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.
Preparation of Peitu Ningfeng Decoction: Codonopsis pilosula (Dangshen) 10g, Astragalus membranaceus (Huangqi) 10g, stir-fried Atractylodes macrocephala (Baizhu) 5g, Poria cocos (Fuling) 10g, Paeonia lactiflora (Hangshao) 10g, Uncaria rhynchophylla (Gouteng) 10g, honey-fried Glycyrrhiza uralensis (Zhi Gancao) 10g.Soak the above herbs (except Uncaria rhynchophylla) in boiling water for 30 minutes, then decoct for 20 minutes. Add Uncaria rhynchophylla later during the decoction process. Each dose
Primary outcome measures
- Functional near-infrared spectroscopy (fNIRS) was used to detect the degree of brain function activation. [Time frame: From enrollment to the end of the one-month treatment period]
- Relative and absolute quantitative analysis of the gut microbiota. [Time frame: From enrollment to the end of the one-month treatment period]
- Determination of Short-Chain Fatty Acids in Feces [Time frame: From enrollment to the end of the one-month treatment period]
- Analysis of Stress Hormones [Time frame: From enrollment to the end of the one-month treatment period]
- Analysis of Oxidative Stress Markers [Time frame: From enrollment to the end of the one-month treatment period]
- Analysis of Cytokines [Time frame: From enrollment to the end of the one-month treatment period]
- Concentration of Neurotransmitters [Time frame: From enrollment to the end of the one-month treatment period]
Secondary outcome measures (2)
- Complete the questionnaire survey [Time frame: From enrollment to the end of the one-month treatment period]
- Complete the questionnaire survey [Time frame: From enrollment to the end of the one-month treatment period]
Eligibility criteria
Inclusion Criteria:① Meet the diagnostic criteria for Pediatric Tic Disorder (Spleen Deficiency and Liver Hyperactivity Type) in both traditional Chinese and Western medicine; ② Aged between 4 and 15 years; ③ Guardians provide informed consent, sign the informed consent form, and are able to adhere to the treatment; ④ No visual impairments such as color blindness or color weakness, and no cognitive impairment disorders.
Exclusion Criteria:① Failure to meet the diagnostic criteria for Pediatric Tic Disorder (Spleen Deficiency and Liver Hyperactivity Type) in both traditional Chinese and Western medicine; ② Presence of involuntary movements caused by other diseases, such as Huntington's chorea, hepatolenticular degeneration, myoclonus, epilepsy, etc.; ③ Allergy to any component of the trial medication; ④ Accompanied by severe conditions such as cardiac, hepatic, renal insufficiency, or hematological system disorders.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
China · 1 center
- Dongdong Qin — Dali
Identifiers
NCT: NCT07417371 · Ethics Review (2025) No. 2