Autism spectrum disorder
Conditions
Interventions
The treatment period is 12 weeks. Participants will receive Kamikihito extract granules at a total daily dose of 7.5 g, administered orally in three divided doses before meals.
Sponsors
Kosaka Hirotaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: 1. Diagnosed with autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 2. Diagnosed with "autism spectrum disorder" or "autism" according to the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). 3. State-Trait Anxiety Inventory (STAI-T) score of >=44 for men or >=45 for women at baseline. 4. Aged 18 years or older at the time of informed consent. 5. Gender: male or female (no restriction). 6. Outpatient status. 7. Full-scale IQ >=70 as measured by the Wechsler Adult Intelligence Scale (WAIS-III or WAIS-IV). 8. No use of herbal medicines within 1 month prior to registration, except for transient conditions such as the common cold. 9. No planned initiation of new drug therapy or addition/reduction of existing medication during the study period. 10. Ability to take oral medications. 11. Written informed consent obtained for participation in this study.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: 1. Individuals whose primary psychiatric diagnosis is other than ASD. 2. Individuals with comorbid organic brain disorders (including epilepsy or dementia), psychotic disorders, bipolar disorder, substance dependence, or other psychiatric disorders. 3. Individuals with a full-scale IQ below 70 as measured by the WAIS-III or WAIS-IV. 4. Individuals who have been newly prescribed psychotropic medications or whose existing medication dosage has been changed within 1 month prior to registration. 5. Individuals who have used intranasal oxytocin within 1 month prior to registration. 6. Individuals with severe comorbid diseases (e.g., liver, kidney, heart, hematologic, metabolic, gastrointestinal disorders, or malignancy) or unstable organ dysfunction. 7. Individuals with hypersensitivity to herbal medicines. 8. Individuals with a history of pseudoaldosteronism. 9. Individuals showing symptoms suggestive of hypokalemia. 10. Pregnant or breastfeeding individuals, those who may be pregnant, or those planning pregnancy during the study period. 11. Individuals currently participating in or planning to participate in an investigational drug study or other clinical research. 12. Individuals deemed inappropriate for participation by the principal investigator or sub-investigators for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in STAI-T score at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to 4 weeks post-intervention in STAI -T score. Change from baseline to 4 weeks and 12 weeks post-intervention in each following items. 1)STAI-T score 2) STAI total score and STAI-S score 3) LSAS-J total score and subscale score 4) HADS total score and subscale score 5) SF-8 total score and subscale score 6) AIS total score and subscale score 7) CGI-I score 8) PGI-I score 9) blood oxytocin and Cortisol 10) salivary oxytocin, Cortisol and total protein 11) Name and dose of antidepressant medication 12) Name and dose of anxiolytic medication | — |
Contacts
Public ContactHirotaka Kosaka
University of Fukui Hospital
Outcome results
None listed