Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Estudio sobre el mecanismo de Pei Tu Ning Feng Tang en el alivio del síndrome de Tourette mediante espectroscopia funcional de infrarrojo cercano (fNIRS) y la vía DA-MAPK-BDNF

29 de septiembre de 2026 actualizado por: Dongdong Qin

Estudio sobre el Mecanismo de Pei Tu Ning Feng Tang en el Alivio del Síndrome de Tourette mediante Espectroscopia Funcional de Infrarrojo Cercano (fNIRS) y la Vía DA-MAPK-BDNF

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Yunnan
      • Dali, Yunnan, Porcelana
        • Dongdong Qin

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

4 años a 15 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

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 is decocted three times:

First decoction: add about 500 mL of water, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter to collect the decoction.

Second decoction: add about 300 mL of water, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter to collect the decoction.

Third decoction: add about 250 mL of water, bring to a boil over high heat, then simmer over low heat for 30 minutes, and filter to collect the decoction.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional near-infrared spectroscopy (fNIRS) was used to detect the degree of brain function activation.
Periodo de tiempo: From enrollment to the end of the one-month treatment period

Functional near-infrared spectroscopy (fNIRS) was used to obtain real-time changes in oxygenated hemoglobin (Oxy-Hb) and deoxygenated hemoglobin (Deoxy-Hb) in cerebral cortical tissues under specific conditions, indirectly reflecting alterations in cerebral aerobic metabolism during brain activity. Children with Tourette syndrome (TS) underwent two fNIRS examinations before and after treatment to quantitatively describe the degree of brain function activation by Pei Tu Ning Feng Tang and to investigate its neural mechanisms underlying the suppression of tics.Unit: mmol/L

From enrollment to the end of the one-month treatment period
Relative and absolute quantitative analysis of the gut microbiota.
Periodo de tiempo: From enrollment to the end of the one-month treatment period

Fecal samples collected from children with TS were analyzed to determine the composition and relative abundance of the gut microbiota. Additionally, representative samples were randomly selected for absolute quantitative analysis of the gut microbiota, reflecting the actual abundance of each microbial taxon and the true differences in samples before and after treatment.In relative quantitative analysis, results are expressed as percentages (%). In absolute quantitative analysis, results are reported as 16S rRNA gene copies per gram of sample (copies/g).

From enrollment to the end of the one-month treatment period
Determination of Short-Chain Fatty Acids in Feces
Periodo de tiempo: From enrollment to the end of the one-month treatment period

In this project, fecal samples were collected from children with TS, and the short-chain fatty acids (SCFAs) in these samples were measured before and after treatment.The commonly used unit for determining SCFAs in feces is micromoles per gram of wet stool weight, i.e., μmol/g wet weight.

From enrollment to the end of the one-month treatment period
Analysis of Stress Hormones
Periodo de tiempo: From enrollment to the end of the one-month treatment period

Levels of stress hormones in peripheral blood were measured before and after treatment.For example, cortisol is commonly measured in nanomoles per liter (nmol/L).

From enrollment to the end of the one-month treatment period
Analysis of Oxidative Stress Markers
Periodo de tiempo: From enrollment to the end of the one-month treatment period

Levels of oxidative stress markers, including superoxide dismutase (SOD), nitric oxide (NO), and malondialdehyde (MDA), in peripheral blood were measured separately before and after treatment.The units are as follows: superoxide dismutase (SOD) activity in U/mL, nitric oxide (NO) metabolites in μmol/L, and malondialdehyde (MDA) in nmol/mL.

From enrollment to the end of the one-month treatment period
Analysis of Cytokines
Periodo de tiempo: From enrollment to the end of the one-month treatment period

Levels of IL-1β, IL-6, and TNF-α in peripheral blood were analyzed before and after treatment.Unit: picogram per milliliter (pg/mL)

From enrollment to the end of the one-month treatment period
Concentration of Neurotransmitters
Periodo de tiempo: From enrollment to the end of the one-month treatment period

In this project, the concentrations of neurotransmitters including dopamine (DA), glutamate (Glu), and gamma-aminobutyric acid (GABA) in peripheral blood were measured before and after treatment.The units are as follows: dopamine (DA) in pg/mL, glutamate (Glu) in μmol/L, and gamma-aminobutyric acid (GABA) in nmol/L or pg/mL.

From enrollment to the end of the one-month treatment period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Complete the questionnaire survey
Periodo de tiempo: From enrollment to the end of the one-month treatment period

The Yale Global Tic Severity Scale (YGTSS) was administered to children before and after treatment to evaluate the therapeutic efficacy of the medication. Scores range from 0 to 75, with higher scores indicating greater severity.

From enrollment to the end of the one-month treatment period
Complete the questionnaire survey
Periodo de tiempo: From enrollment to the end of the one-month treatment period

The Pediatric Tourette Syndrome Traditional Chinese Medicine Syndrome Score Scale (Spleen Deficiency and Liver Hyperactivity Type) was administered to children before and after treatment to evaluate the therapeutic efficacy of the medication. Scores range from 0 to 54, with higher scores indicating greater severity.

From enrollment to the end of the one-month treatment period

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2026

Finalización primaria (Actual)

30 de septiembre de 2026

Finalización del estudio (Actual)

30 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

2 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de febrero de 2026

Publicado por primera vez (Actual)

18 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Ethics Review (2025) No. 2

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No consent for IPD sharing was obtained from participants.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .