Suspected Orthostatic Dysregulation (Orthostatic Dizziness) Orthostatic Dysregulation, Orthostatic Dizziness, Thiamine Responsive Disorders
Conditions
Interventions
Fursultiamine hydrochloride (25 mg tablets) will be administered at four tablets per day for 20 days.
Thiamine
Vitamin B1, Fursultiamine Hydrochloride
Sponsors
Hadano Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 45 years 2. Self-reported orthostatic dizziness occurring at least once within the past two weeks 3. Able to attend study visits in accordance with the study schedule
Exclusion criteria
Exclusion criteria: 1. History of syncope within the past two weeks 2. History or findings of major cardiac disease considered unsafe for orthostatic testing 3. Use of fortified foods, dietary supplements, or prescription medications containing 5 mg/day or more of vitamin B1 on 6 or more days within the past 32 days 4. Does not provide consent to participate in the study 5. Participation is not considered voluntary due to a suspected relationship with the investigator or others 6. Unable to sufficiently understand the study due to cognitive impairment, language difficulties, or similar reasons 7. Judged by the principal investigator or sub-investigators to be unable to participate safely, due to symptoms, underlying diseases, or a history of syncope-related injury 8. Judged by the principal investigator or sub-investigators to be inappropriate for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group difference in the proportion of participants with improvement in orthostatic dizziness at 20 days after treatment or no treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Between-group difference in the change in frequency of orthostatic dizziness at 20 days after treatment or no treatment 2. Between-group difference in the change in severity of orthostatic dizziness at 20 days after treatment or no treatment 3. Between-group difference in the proportion of participants with improvement in orthostatic dizziness stratified by sex 4. Between-group difference in the proportion of participants with improvement in orthostatic dizziness stratified by alcohol consumption 5. Between-group difference in the proportion of participants with improvement in orthostatic dizziness stratified by the total score and specific items of the Dietary Variety Score 6. Between-group difference in the proportion of participants with improvement in orthostatic dizziness among participants with a positive new orthostatic test, overall and stratified by each diagnosis 7. Between-group difference in the proportion of participants with improvement in orthostatic dizziness stratified by blood pressure, heart rate, and initial recovery time of blood pressure. 8. Between-group difference in the proportion of participants with improvement in orthostatic dizziness stratified by %FMD | — |
Contacts
Public ContactTakahiro Hadano
University of Tsukuba
Outcome results
None listed