NIPH Clinical Trials Search

Kamikihito study for autism spectrum disorder

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Autism spectrum disorder
Date of first enrollment	09/01/2026
Target sample size	29
Countries of recruitment
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome

Change from baseline in STAI-T score at 12 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.