None listed
Conditions
Interventions
Drug : This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of Ginexin-F Tab. 80 mg (SK Chemicals) on orthostatic intolerance (OI).
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 20 to 65 years (both male and female). 2. Meets at least one of the following conditions: 1) A decrease in systolic blood pressure (SBP) of =20 mmHg or a decrease in diastolic blood pressure (DBP) of =10 mmHg within 3 minutes during the head-up tilt test (HUTT). An increase in heart rate (HR) of =30 beats per minute within 10 minutes of standing without orthostatic hypotension, as observed during the head-up tilt test (HUTT). 2) Persistent symptoms for at least 6 months upon standing, such as dizziness, palpitations, tremors, generalized weakness, blurred vision, or fatigue. 3. Provides written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with structural heart disease or arrhythmia. 2. Patients diagnosed with thyroid or adrenal gland disorders. 3. Patients with active systemic diseases, including but not limited to: Infectious diseases, autoimmune diseases, malignant tumors, Chronic obstructive pulmonary disease (COPD), Hepatitis or liver cirrhosis, Acute heart failure or myocardial infarction, Pernicious anemia, Acute respiratory diseases. 4. Women who are currently pregnant, breastfeeding, or planning to conceive. 1) Women of childbearing potential (20–49 years old)* must have a negative urine pregnancy test before receiving the investigational drug. Participants with a positive pregnancy test will be excluded. 2) Definition of women of childbearing potential (20–49 years old): Women who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) and are not postmenopausal (defined as =60 years old or =12 months of amenorrhea if under 60 years old). The standard medical definition of reproductive age is 15–49 years, but for this study, the range is 20–49 years, based on the characteristics of adult neurology outpatients. 3) Female participants must avoid pregnancy and breastfeeding throughout the screening period and during the investigational treatment. In addition to the initial pregnancy test, pregnancy status will be monitored at each visit. 5. Patients currently undergoing treatment with antidepressants or psychiatric medications, including SSRIs, SNRIs, TCAs, and other antipsychotics. However, the use of mood stabilizers, benzodiazepines, or sleep medications is permitted if the dosage remains stable throughout the study period. 6. Patients with =50% cerebrovascular stenosis, as observed in recent (within one year) cerebrovascular imaging (e.g., MR angiography or CT angiography). 7. Patients with a history of hypersensitivity to Ginexin-F. 8. Patients with a known hypersensitivity or allergic reaction to Tartrazine (Yellow No. 4), an ingredient in the investigational drug. 9. Patients with other medical conditions deemed inappropriate for study participation at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Dizziness Handicap Inventory (DHI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-Form 36 | — |
Countries
Korea, Republic of
Contacts
Public ContactDayoung Seo
Asan Medical Center
Outcome results
None listed