None listed
Conditions
Interventions
Dietary Supplement : The experimental group takes SB-109 which contains a mixture of Platycodon grandiflorum extract and Poncirus trifoliate extract. Participants take two tablets(one tablet is 600mg
Sponsors
Sungkyunbiotech
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) men and women over 20 and under 75 2) Those with a Stress Response Inventory(SRI) of 50 or more and 115 or less 3) If one or more of the depression/anxiety scales apply ? Those with Hamilton Depression Scale (HAM-D) of 8 or more and 16 or less ? Those with a Hamilton anxiety scale (HAM-A) of 15 or more and 23 or less 4) Those who agreed to participate in this clinical trial prior to the beginning of the clinical trial and signed the informed consent form
Exclusion criteria
Exclusion criteria: Those who meet one or more conditions are excluded from clinical trials. 1) Those currently being treated with severe cardiovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious diseases, and malignant tumors. 2) Those with alcohol use/inducing disabilities and central nervous system disorders 3) Those with a history of schizophrenia 4) Those with major depression disorder/mental illness based on DSM-5(The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) 5) Those with withdrawal symptoms of alcohol and smoking prohibition 6) Those who are being treated for dementia within 3 months of visit 1. 7) Those who are being treated for depression and stress anxiety within 4 weeks of the visit 1. 8) Those who have acute stress (family death/imprisonment/divorce/separation/ debt/run away/delinquency/affair/business failure/serious illness/remarriage, etc.) within 4 weeks of visit 1. 9) Those who have taken oral steroids and adrenocortical hormones within 4 weeks of visit 1. 10) Those who have taken sleeping piils within 2 weeks of visit 1 11) Those who have taken health functional foods related to stress improvement within 2 weeks of visit 1. 12) Patients with uncontrolled hypertension(systolic blood pressure above 160mmHg or diastolic blood pressure above 100mmHg, clinical trial subjects measured after 10 minutes of rest) 13) Patients with uncontrolled diabetes(fasting blood sugar level is 180 or higher, or start taking medications for diabetes within 3 months of visit 1) 14) Those who are being treated or taking medications for thyroid disease 15) Those whose creatine is more than twice the normal upper limit 16) Those whose AST(GOT) or ALT(GPT) is more than three times the normal upper limit 17) Those who are pregnant, lactating women, or have a plan of pregnancy during a clinical trial. 18) Those who have participated in other interventional clinical trial within one month(30 days) of visit 1 or plan to participate in other interventional clinical trials after participating this clinical trial 19) Those who are sensitive to or allergic to the ingredients of this clinical trial food 20) those who are judged inappropriate by the researcher for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perceived Stress Scale(PSS);Korean-Beck Depression Inventory-II(K-BDI-II);Korean-Beck Anxiety Inventory(K-BAI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart Rate Variability(HRV);Pittsburgh Sleep Quality Index(PSQI);blood cortisol level ;drenocorticotrophic hormon(ACTH);functional near-infrared spectroscopy (fNIRS) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun Chan Hwang
Chung-Ang Univerisity Hospital
Outcome results
None listed