None listed
Conditions
Interventions
Dietary Supplement : Four capsules of DKB-135 or placebo (500mg/capsule) will be orally administered one time a day (30-60 min before bedtime) for 4 weeks.
Sponsors
Dong Kook Pharm
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged between 19 and 65 years old. 2) Those with PSQI (Pittsburgh Sleep Quality Index) score 5 or higher. 3) Those with ISI-K (Korean Version of Insomnia Severity Index) score between 8 and 21. 4) Those who agreed to participate and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those with severe diseases in cardiovascular system, immune system, respiratory system, gastrointestinal/hepatic and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease, or malignant tumor. 2) Those with disease or symptoms that could affect the sleep, such as nocturia. 3) Those with alcohol use disorder and who are being treated by hospitalization, medications, or rehabilitation. 4) Those with major depressive disorders, generalized anxiety disorders, post-traumatic stress disorders, or obsessive-compulsive disorder according to the DSM-V criteria. a) Those with PHQ-9 score 10 or higher at visit 1 b) Those with GAD-7 score 5 or higher at Visit 1. 5) Those who are being treated for inflammatory bowel disease at visit 1. 6) Those with past or current history of schizophrenia or bipolar disorder. 7) Those with disease of cognitive decline, such as dementia (based on DSM-V) or Parkinson’s diseases. 8) In case of polysomnography cannot be performed, 9) Those who are being treated for sleep disorders (Insomnia, Narcolepsy, Obstructive sleep apnea, Restless Legs Syndrome, Periodic Limb Movement Disorder, etc.) within 4 weeks at visit 1 (Those who administered sleep medications within 4 weeks, Those who are currently under treatment of continuous positive airway pressure at visit 1) a) Those with STOP-Bang score 5 or higher at Visit 1. 10) Those with body mass index (BMI) 30 kg/m2 or higher; or 18 kg/m2 or lower at visit 1. 11) Those with alcohol or smoking withdrawal symptoms. 12) Current smokers. 13) Heavy caffeine drinkers (>400 mg (4 cups/day)} 14) Those with excessive drinking within 4 weeks (168 g/week for men, 84 g/week for women) or those who are suspected of alcohol-induced sleep disorders at visit 1. 15) Those with irregular sleep patterns within 4 weeks due to the shift or night work at visit 1. 16) Those with acute stress (family death, arrest, divorce, separation, debt, runaway from home, derogation, extramarital affair, business failure, serious illness, remarriage, etc.) within 4 weeks of visit 1. 17) Those who visited a country in different time zone within 4 weeks of visit 1. 18) Those who took oral steroids within 4 weeks of visit 1. 19) Those who took medications that could affect sleep (antipsychotics, antidepressants, anti-anxiety drugs, sleep medications, melatonin, stimulants, beta-blockers, bronchodilators, antihistamines, etc.) within 4 weeks of visit 1. 20) Those who took dietary supplements related to sleep improvement within 4 weeks of visiting 1. 21) Those with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher) 22) Those with uncontrolled diabetics (Blood glucose of 180 mg/dL or higher, or took new diabetes medication within 3 months 23) Those with TSH 0.1 µIU/mL or lower; or 10 µIU/mL or higher. 24) Those with creatinine higher than twice the upper limit of the normal range. 25) Those with AST (GOT) or ALT (GPT) higher than three times the upper limit of the normal range. 26) Those who have participated in other interventional clinical trials within 4 weeks of visit 1 or plan to participate in other interventional clinical trials after the start of this clinical trial. 27) Those who are pregnant, lactating women, or planning pregnancy during the clinical trial period. 28) Those who are sensitive or allergic to the ingredients of the clinical trial. 29)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI-K(Korean Version of Pittsburgh Sleep Quality Index) | — |
Secondary
| Measure | Time frame |
|---|---|
| ISI-K(Korean Version of Insomnia Severity Index);KESS(Korean Version of Epworth Sleepiness Scale);PSG(TST, SE, SOL, WASO);Sleep Diary(TST, SE, SOL, WASO);Blood Biomarker(Cortisol, CRP, Adiponectin) | — |
Countries
Korea, Republic of
Contacts
Public ContactWon Shul Sin
Kyung Hee University Hospital at Gangdong
Outcome results
None listed