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Идёт набор NCT07417371

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

Без фазы С лечением Tourette Syndrome in Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment..
Кому может быть актуально
Состояния в реестре: Tourette Syndrome in Children. Базовые параметры: 4 лет — 15 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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.

Вмешательства

  • Препарат 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

Первичные конечные точки

  • Functional near-infrared spectroscopy (fNIRS) was used to detect the degree of brain function activation. [Срок оценки: From enrollment to the end of the one-month treatment period]
  • Relative and absolute quantitative analysis of the gut microbiota. [Срок оценки: From enrollment to the end of the one-month treatment period]
  • Determination of Short-Chain Fatty Acids in Feces [Срок оценки: From enrollment to the end of the one-month treatment period]
  • Analysis of Stress Hormones [Срок оценки: From enrollment to the end of the one-month treatment period]
  • Analysis of Oxidative Stress Markers [Срок оценки: From enrollment to the end of the one-month treatment period]
  • Analysis of Cytokines [Срок оценки: From enrollment to the end of the one-month treatment period]
  • Concentration of Neurotransmitters [Срок оценки: From enrollment to the end of the one-month treatment period]
Вторичные конечные точки (2)
  • Complete the questionnaire survey [Срок оценки: From enrollment to the end of the one-month treatment period]
  • Complete the questionnaire survey [Срок оценки: From enrollment to the end of the one-month treatment period]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Китай · 1 центр
  • Dongdong Qin — Dali

Идентификаторы

NCT: NCT07417371 · Ethics Review (2025) No. 2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗