Patients with chronic vertigo
Conditions
Interventions
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)
Sponsors
Kitahara Tadashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma AVP level from baseline to Day 28 following the start of intake of food containing Enzymolyzed Honeybee Larvae. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) | — |
Contacts
Public ContactHitoshi Akazawa
Nara Medical University Hospital
Outcome results
None listed