None listed
Conditions
Interventions
Drug : - Intervention Group (Bojungikgi-tang): one pack (2.06 g) per dose, three times daily, administered for 8 weeks
- Control Group (Socheongryong-tang): one pack (2.67 g) per dose, three times dai
Sponsors
Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults aged 19 to 65 years. 2. A Fatigue Severity Scale (FSS) total score of 36 or higher. 3. A documented history of persistent allergic rhinitis for at least 2 years prior to study participation. 4. A positive result for perennial allergens on a skin allergy test (skin prick test or intradermal test), Multiple Allergen Simultaneous Test (MAST), or ImmunoCAP performed within the previous 12 months. Positivity is defined as follows: - Skin prick test: Wheal diameter =3 mm larger than the negative control. - Intradermal test: Wheal diameter =7 mm larger than the negative control. - MAST or ImmunoCAP: Class 2 or higher. 5. A 7-day average reflective Total Nasal Symptom Score (r-TNSS) of 5 or higher (maximum score: 12), assessed during the week preceding Visit 2. 6. Willing and able to complete the study diary. 7. Voluntarily provides written informed consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Individuals with non-allergic rhinitis (e.g., vasomotor, infectious, or drug-induced rhinitis). 2. Individuals with asthma. 3. Individuals with obstructive nasal polyps or other clinically significant nasal structural abnormalities (e.g., severe nasal septal deviation). 4. History of nasal trauma or surgery within 12 weeks prior to Visit 1. 5. History of acute or chronic sinusitis within 4 weeks prior to Visit 1. 6. Initiation or dose adjustment of allergen immunotherapy within 4 weeks prior to Visit 1. 7. Current use of long-acting antihistamines. 8. Upper respiratory tract infection (including the common cold) or systemic infection within 2 weeks prior to Visit 1. 9. Current or past history of underlying diseases that may cause fatigue, including but not limited to cancer, sleep disorders, active hepatitis A, chronic hepatitis, liver cirrhosis, chronic kidney disease, active tuberculosis, hypothyroidism, or multiple sclerosis. 10. Renal impairment (serum creatinine =2.0 × the upper limit of normal [ULN]). 11. Hepatic dysfunction (ALT or AST =2.0 × ULN). 12. Uncontrolled hypertension (diastolic blood pressure >100 mmHg or systolic blood pressure >180 mmHg). 13. Uncontrolled diabetes mellitus (random blood glucose =200 mg/dL at screening). 14. Use of prohibited concomitant medications or anticipated need for prohibited medications during the study period. Subjects may participate if the following medications have been discontinued for at least the specified washout period before screening: - Intranasal, topical, ophthalmic, or systemic antihistamines: 3 days (10 days for long-acting antihistamines such as loratadine, fexofenadine, or cetirizine; 14 days for ketotifen; 3 months for astemizole) - Intranasal cromolyn or nedocromil: 14 days - Anticholinergic agents: 3 days - Intranasal or systemic decongestants: 3 days - Topical or systemic corticosteroids: 30 days - Reserpine: 3 days - Antitussives or expectorants: 3 days - Leukotriene modifiers: 7 days - Systemic antibiotics: 14 days - Nonsteroidal anti-inflammatory drugs (NSAIDs): 2 days - Immunosuppressants: 90 days - Psychotropic medications: 30 days - Herbal medicines, traditional herbal preparations, or dietary supplements that may affect fatigue or allergic rhinitis: 14 days 15. Chronic use of medications that may affect the efficacy assessment of the investigational product, including tricyclic antidepressants, ß-agonists, or bronchodilators. 16. Fewer than 4 days of recorded reflective Total Nasal Symptom Score (r-TNSS) assessments in the subject diary during the week prior to Visit 2. 17. Planned prolonged travel or absence from the study area during the study period that would interfere with study participation. 18. History of alcohol or drug abuse. 19. History of hypersensitivity to the investigational product or any of their ingredients/excipients. 20. Myopathy associated with hyperaldosteronism or hypokalemia. 21. Hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 22. Individuals unwilling to use medically acceptable contraception from the time of informed consent until completion of study participation. ? Acceptable contraceptive methods include: - An intrauterine device (IUD) with documented contraceptive efficacy used by the participant's partner; - Barrier contraception (male or female) used together with spermicide; - Surgical sterilization of the participant or partner (vasectomy, tubal ligation, or hysterectom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| r-TNSS (Reflective Total Nasal Symptom Score) | — |
Secondary
| Measure | Time frame |
|---|---|
| FSS (Fatigue severity scale);r-TNSS (Reflective Total Nasal Symptom Score);i-TNSS (Instantaneous Total Nasal Symptom Score);Rhinitis control assessment test;KARQLQ(Korean Allergic Rhinitis specific Quality of Life Questionnaire) ;Visual Analogue Scale for Fatigue;Visual Analog Scale for Digestive Symptoms;Visual Analog Scale for Sleep;Biomarker (total IgE, eosinophil count) ;HINT-8 (Health-related Quality of Life Instrument with 8 Items);Overall assessment;Adverse events;Hematology and blood chemistry tests;vital sign | — |
Countries
Korea, Republic of
Contacts
Public ContactSo-jung Park
Pusan National University Korean Medicine Hospital
Outcome results
None listed