None listed
Conditions
Interventions
Others(Sword bean pod(Canavalia gladiata)) : - Test food: SBP extract
- Intake period: 6 weeks
- Dosage and intake frequency
* Test group (SBP): 6 weeks, once a day, 3 tablets per time, taken orally w
Sponsors
Dankook Univeristy Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria were as follows : (1) aged 19 to 65 years; (2) WBC within the normal range (4-10 × 103/µL) at the screening visit; (3) allergic nasal symptoms to allergens throughout the year within the past 12 months; (4) total nasal symptom score = 4; (5) not receiving treatment for allergic rhinitis (drug therapy, non-drug therapy, or other treatments) during the trial period; and (6) agreed in writing to voluntarily participate in this examination and to comply with the requirements.
Exclusion criteria
Exclusion criteria: 1) Those who have taken immunosuppressants, antibiotics, nonsteroidal anti-inflammatory drugs, steroid drugs, or antihistamines within the past 2 weeks 2) Those with autoimmune diseases, inflammatory systemic diseases, metabolic syndrome, or infectious diseases 3) Those diagnosed with severe cardiovascular disease and receiving treatment 4) Those with uncontrolled hypertension (those with hypertension of 160/100 mgHg or higher or those taking new medication for hypertension within the past 3 months) 5) Those with uncontrolled diabetes (those with fasting blood sugar of 180 mg/dl or higher or those taking new medication for diabetes within the past 3 months) 6) Those with liver or kidney damage (AST: 100 IU/L or higher, ALT: 100 IU/L or higher, ?-GTP: 100 IU/L or higher, Creatinine: 1.4 mg/dl or higher) 7) Those with gastrointestinal diseases (e.g., Crohn's disease, ulcers, etc.) that may affect the absorption of human food Those with a history of surgery (except simple appendectomy or hernia surgery) 8) Those with a history of hypersensitivity or clinically significant hypersensitivity to drugs containing extracts of the same class of ingredients as the extract of the plant, or other drugs (aspirin, antibiotics, etc.) 9) Those being treated for thyroid disease 10) Those diagnosed with cancer within the past year or currently being treated 11) Those who have taken other clinical trial drugs or test foods within the past 3 months 12) Those who have donated whole blood within 60 days or component blood within 30 days or received a blood transfusion within 30 days prior to the first administration of the human application food 13) Those who have taken drugs that induce or inhibit drug metabolism enzymes, such as barbiturates, within 30 days prior to the first administration of the human application food 14) Those who have consumed excessive alcohol (Men: <30 g/day (about 3 glasses of beer or 3 glasses of soju), Women: <20 g/day (about 2 glasses of beer) 2 glasses, about 2 glasses of soju) 15) Those with a history of drug abuse or neuropsychiatric disorders (depression, schizophrenia, etc.) 16) Those who are pregnant or breastfeeding 17) Those who are judged by the tester to be unsuitable for this human application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reflective Total Nasal Symptom Score(rTNSS) and symptoms scores;AM/PM reflective Total Nasal Symptom Score(rTNSS), instantaneous Total Nasal Symptom Score(iTNSS), Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ), Patients' Global Impression of Change(PGIC);Cytokine(Interferon gamma, Tumor Necrosis Factor-a, Interleukin 4, Interleukin 5), White Blood Cell, Immunoglobulin E, Eosinophil Cationic Protein, Histamine, Prostaglandin, Leukotriene | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions, clinical laboratory tests, vital signs, physical examination | — |
Countries
Korea, Republic of
Contacts
Public ContactBoeun Kim
Dankook Univeristy Hospital
Outcome results
None listed