None listed
Conditions
Interventions
Dietary Supplement : Participants will take their assigned product once a day (at any time of day), two tablets with plenty of water, for four weeks. The main ingredient of the test product is the Pla
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 20 to 75 years who have experienced sino-nasal symptoms continuously for more than 3 months (e.g., chronic rhinitis, allergic rhinitis, non-allergic rhinitis, chronic rhinosinusitis, etc.) 2) Individuals with a score of 8 or higher on the Sino-Nasal Outcome Test-22 (SNOT-22) 3) Individuals with a score between 8 and 21 (mild to moderate level) on the Korean version of the Insomnia Severity Index (ISI-K) 4) Individuals who have agreed to participate in the study before the start of the clinical trial and have signed the Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) Individuals currently undergoing treatment for severe cardiovascular system, immune system, respiratory system, hepatobiliary system, renal and urogenital system, nervous system, musculoskeletal system, infectious diseases, or malignant tumors 2) Individuals with alcohol use disorder, substance use disorder, neurocognitive disorder, or central nervous system disorders 3) Individuals with a history of severe mental disorders such as schizophrenia or recurrent major depressive disorder based on DSM-V criteria 4) Individuals receiving treatment for depression or anxiety disorders within 4 weeks prior to Visit 1 5) Individuals who have had a dosage change in oral steroids, corticosteroids, or antihistamines within 4 weeks prior to Visit 1 6) Individuals who have taken sleep medications within 2 weeks prior to Visit 1 7) Individuals who have taken health supplements related to allergies, sleep improvement, or stress within 2 weeks prior to Visit 1 8) Pregnant or breastfeeding women, or women planning to become pregnant during the study period 9) Individuals who have participated in another interventional clinical trial within 30 days prior to Visit 1, or who plan to participate in another interventional clinical trial during this study 10) Individuals with sensitivities or allergies to the ingredients of the study food 11) Individuals deemed inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index(PSQI);Actigraphy(Index: Total sleep time(TST), Sleep latency(SL), Wake after sleep onset (WASO), Percent sleep efficiency, REM sleep-related index));Sino-Nasal Outcome Test-22(SNOT-22) | — |
Secondary
| Measure | Time frame |
|---|---|
| Korean version of Insomnia Severity Index(ISI-K);Total Nasal Symptom Score(TNSS);Stress Response Inventory(SRI);Heart Rate Variability(HRV);functional Near Infrared Spectroscopy(fNIRS);Blood tests (serum IgE, cortisol, ACTH, CRP, eosinophils, hemoglobin, hematocrit, MCV, MCH);Epworth Sleepiness Scale(ESS);Morningness-Eveningness Questionnaire(MEQ);Sleep Diary ;IL-2, IL-6, IL-10, TNF-alpha | — |
Countries
Korea, Republic of
Contacts
Public ContactSun Mi Kim
Chung-Ang Univerisity Hospital
Outcome results
None listed