NIPH Clinical Trials Search

Honey V

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients with chronic vertigo
Date of first enrollment	17/09/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Lyophilized powder of enzymatically degraded honeybee larvae 720 mg/4 capsules/day (2 capsules each after breakfast and dinner for 28 days with room temperature water)

Outcome(s)

Primary Outcome

Change in plasma AVP level from baseline to Day 28 following the start of intake of food containing Enzymolyzed Honeybee Larvae.

Secondary Outcome

- Safety of the food containing Enzymolyzed Honeybee Larvae (assessment of hypersensitivity). - Change from baseline in plasma cortisol level at Day 28 following the start of intake of the food containing enzymolyzed Honeybee Larvae. - Change from baseline in scores for the following questionnaires/scales: - Dizziness Handicap Inventory - Japanese version (DHI-J) - Self-rating Depression Scale (SDS) - State-Trait Anxiety Inventory (STAI) - Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) - Stress Response Scale-18 (SRS-18)

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	< 65age old
Gender	Both
Include criteria	1. Age:>= 20 years and < 65 years. 2. Condition: Diagnosis of chronic dizziness with symptom duration of at least 3 months despite continued conventional treatment 3. Biomarker: Plasma AVP concentration of 3.0pg/ml or higher, measured at the time of obtaining informed consent.
Exclude criteria	1. Hypersensitivity to foods containing enzyme-hydrolyzed bee pupae/larvae, shrimp, or crab. 2. History of diagnosis of central nervous system (CNS) disorders, including pituitary disease, stroke, Parkinson's disease or Parkinsonism, multiple sclerosis, acoustic neuroma, or brain tumor. 3. Under treatment with vasopressin receptor antagonist 4. History of diagnosis of severe psychiatric disorders, including anxiety disorder, depression, or schizophrenia. 5. Currently undergoing treatment for hepatic impairment or renal impairment. 6. Judged by the Principal Investigator (or Sub-Investigator) as unsuitable for participation in the study. 7. Continuous or intermittent intake of foods containing enzyme-hydrolyzed bee pupae/larvae within the past 3 months. 8. Any change in medication regimen (including initiation, dose increase, or dose decrease) within the past 3 months.