A 8-week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of KBL396 on improvement of Sleep quality in adults with Sleep disorders, Stress, Anxiety, and Depressio
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0006865
- Lead Sponsor
- Kobiolabs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 105
1) Men and women over 19 and under 65
2) A person whose Pittsburgh sleep quality inventory- Korean version (PSQI-K) is 5 or more
3) A person whose stress response inventory (SRI) scale is 81 or more and has 120 or less points
3) A person who belongs at least one of those two
(1) A person whose Korean-Beck Anxiety scale (K-BAI) is 16 or more points and 45 or less
(2) A person whose Korean-Beck Depression Inventory-II (K-BDI-II) scale is 20 or more and 45 or less
5) A person who agrees to participate in this human body application test before the human body application test begins and has signed the Informational content
1) A person who is currently being treated for severe disorders of cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary tract, kidney and urinary system, musculoskeletal system, infectious diseases and malignant tumors
2) A person who has been diagnosed with mental illness such as schizophrenia and bipolar disorder
or has been diagnosed as a mental patient such as schizophrenia and bipolar disorder
3) A person who is currently being treated for major depression, generalized anxiety disorder, post-traumatic stress disorder, and obsessive-compulsive disorder, etc., on the basis of DSM-V
4) A person who is being treated for inflammatory bowel disease based on visit 1
5) A person who is suffering from mental illness such as schizophrenia or bipolar disorder or have a medical history
6) A person who is being treated for dementia within 3 months based on visit 1
7) A person who is being treated for sleep disorder within 4 weeks based on visit 1 (Insomnia, Periodic Limb Movement in Sleep (PLMS), Restless leg syndrome (RLS), Sleep apnea, etc.) including treatment method such as sleeping pills, positive pressure devices, etc.)
8) A person whose body mass index (BMI) is 35 kg/m2 or more at visit 1
9) A person who shows withdrawal symptoms from drinking and smoking
10) Current smokers
11) A person who has drank excessively in the last 1 month based on visit 1 (men: more than 14 soju/week, women: more than 7 soju/week based on alcohol content)
12) A person who has done shift work and night work within 4 weeks based on visit 1 or a person with irregular sleep habits
13) A person who has acute stress (dead/marriage/separate/liberation/liberation/discharge/disappear/
business failure/critical illness/marriage, etc.) within four weeks of the start of the test14) Those who visit a place with time difference within 4 weeks of visit 1
15) A person who took oral steroids and adrenal cortex hormones within four weeks of the start of a
test
16) A person who administered immune-suppressants within 4 weeks based on visit 1
17) A person who administered whole-body antibiotics within 2 weeks based on visit 1
18) A person who took probiotics and lactic acid bacteria products or intestinal agents continuously (4 times a week or more) within 2 weeks based on visit 1
19) A person who took drugs that affect sleep (anticonvulsants, antidepressants, beta blockers, bronchodilators, stimulants, Melatonin, sedative antidepressant, antihistamines, antipsychotics, etc.) within 2 weeks based on visit 1
20) A person who consumed health functional foods related to improving sleep, stress, anxiety, and depression within 2 weeks based on visit 1
21) A person with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measured after 10 minutes of rest for human subjects)
22 A person with uncontrolled diabetes (blood sugar of 180 mg/dL or more, or starting a new drug due to diabetes within 3 months)
23) A person whose TSH is 0.5 uIU/mL or less or 7.0 uIU/mL or more
24) A person who are being treated for thyroid disease or on medication
25) A person whose creatinine is more than twice the normal upper limit of the testing institution
26) A person whose AST(GOT) or ALT(GPT) is 3 times or more than the normal upper limit of the testing institution
27) A person who have participated in other interventional clinical trials (including human app
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSQI-K(Korean version of Pittsburgh Sleep Quality Index);SRI(Stress Response Inventory);K-BAI(Korean-Beck Anxiety Inventory);K-BDI-II(Korean-Beck Depression Inventory-II)
- Secondary Outcome Measures
Name Time Method ISI-K(Korean version of Insomnia Severity Index);KESS(Korean version of Epworth Sleepiness Scale);PSS-10(Perceived Stress Scale-10);K-STAI(Korean adaptation of Spielberger’s State Trait Anxiety Inventory);HARS(Hamilton Anxiety Rating Scale);K-HDRS(Korean version Hamilton Depression Rating Scale);K-MADRS(Korean version Montgomery-Åsberg Depression Rating Scale);NRS(Numeric Rating Scale);Actigraphy and sleep diary (SE: Sleep Efficiency, TST: Total Sleep Time, WASO: Wake up After Sleep Onset, SOL: Sleep Onset Latency) ;Blood biomarkers(Cortisol, Adiponectin, Leptin, CRP, BDNF, Serotonin, Dopamine);Immune cytokine(IL-1a, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IFN-?, TNF-a) ;Urine biomarker(5-HIAA),;Fecal microbiome