Tourette Syndrome in ChildrenNCT07417371
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
A study testing Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. in people with Tourette Syndrome in Children, run by Dongdong Qin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Tourette Syndrome in Children
- What is being tested?
- Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tourette Syndrome in Children
- Being tested
- Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. | Experimental | 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. Receives: Drug: Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional near-infrared spectroscopy (fNIRS) was used to detect the degree of brain function activation.
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
Measured: From enrollment to the end of the one-month treatment period
Relative and absolute quantitative analysis of the gut microbiota.
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).
Measured: From enrollment to the end of the one-month treatment period
Determination of Short-Chain Fatty Acids in Feces
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.
Measured: From enrollment to the end of the one-month treatment period
Analysis of Stress Hormones
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).
Measured: From enrollment to the end of the one-month treatment period
Analysis of Oxidative Stress Markers
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.
Measured: From enrollment to the end of the one-month treatment period
Analysis of Cytokines
Levels of IL-1β, IL-6, and TNF-α in peripheral blood were analyzed before and after treatment.Unit: picogram per milliliter (pg/mL)
Measured: From enrollment to the end of the one-month treatment period
Concentration of Neurotransmitters
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.
Measured: From enrollment to the end of the one-month treatment period
Secondary outcomes (2)
Complete the questionnaire survey
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.
Measured: From enrollment to the end of the one-month treatment period
Complete the questionnaire survey
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.
Measured: From enrollment to the end of the one-month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Apr 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette Syndrome in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongdong Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongdong Qin, Yunnan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417371
- Sponsor's protocol ID
- Ethics Review (2025) No. 2
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No consent for IPD sharing was obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07417371
- Acronym / sponsor ID
- Ethics Review (2025) No. 2
- Conditions
- Tourette Syndrome in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dongdong QinUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. | Experimental | Drug: 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. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Drug | Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. |
Primary outcome
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
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
Relative and absolute quantitative analysis of the gut microbiota.
Time frame: 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).
Determination of Short-Chain Fatty Acids in Feces
Time frame: 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.
Analysis of Stress Hormones
Time frame: 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).
Analysis of Oxidative Stress Markers
Time frame: 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.
Analysis of Cytokines
Time frame: 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)
Concentration of Neurotransmitters
Time frame: 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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. No consent for IPD sharing was obtained from participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. in people with Tourette Syndrome in Children, run by Dongdong Qin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.