NIPH Clinical Trials Search

The efficacy of hachimijiogan for Alzheimers disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	mild Alzheimers disease
Date of first enrollment	28/04/2026
Target sample size	200
Countries of recruitment
Study type	Interventional
Intervention(s)	Subjects will be randomized based on age, sex,and will be administered either hachimijiogan Extract Granules (7.5g, 3 times a day before meals (or after meals)) or a placebo for 6 months.

Outcome(s)

Primary Outcome	ADAS-Jcog
Secondary Outcome	Disability assessment of Dementia Grip strength Advanced Glycation End Products

Key inclusion & exclusion criteria

Age minimum	>= 60age old
Age maximum	< 85age old
Gender	Both
Include criteria	1) 60 to under 85 years old 2) Patients with Alzheimers dementia (those who meet the diagnostic criteria for Alzheimers dementia according to DSM-5) 3) Those with a baseline MMSE score of 15 to 26 4) Those with a baseline ABC dementia scale score of 86 to 100 or CDR 1.0 5) Patients who have been using donepezil, galantamine, or rivastigmine at a fixed dose for the past three months. 6) Patients who have signed an informed consent form for participation in the study, who can be contacted frequently by the patient, and who have a trustworthy study partner (parents, siblings, children/grandchildren, relatives living in the same household, or persons considered to be equivalent to such close relatives) who can respond at designated times.
Exclude criteria	1) Receiving non-pharmacological therapy for the treatment of AD 2) Taking Kampo Medicine 3)Regularly consume health functional foods that may influence the study three or more times per week and cannot discontinue them within three weeks prior to the study start date 4)Prior experience of anti-amyloid beta antibody drug therapy 5) Taking Memantine 6) Kidney disfunction (eGFR<30mL/min/1.73mm2) 7) AST or ALT>100mg/dl 8)Change of drug dosage or type that could affect the progression cognitive function during the three months 9) Complication with gastric ulcer, bronchial asthma, or epilepsy. 10) Judged by doctors not to be suited for study, such as having serious complications