KCT0007750
Recruiting
未知
A 8-week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of LTC-022 on Improvement of sleep quality
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Korea Institute of Oriental Medicine
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Aged between 30 and 59 years old.
- •(2\) Those with Pittsburgh Sleep Quality Index (PSQI) score of grater than 5\.
- •(3\) Those with Insomnia Severity Index (ISI) score between 8 and 21\.
- •(4\) Those who agreed to participate and signed the informed consent form.
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 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\)
- •(3\) Those with major depressive disorders, generalized anxiety disorders, post\-traumatic stress disorders, or obsessive\-compulsive disorder according to the DSM\-V criteria.
- •? Those with PHQ\-9 score 10 or higher at visit 1\.
- •? Those with GAD\-7 score 5 or higher at Visit 1\.
- •(4\) Those with past or current history of schizophrenia or bipolar disorder.
- •(5\) Those with disease of cognitive decline, such as dementia or Parkinson’s diseases, or head trauma accompanied by loss of consciousness/convulsions.
- •(6\) 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\.
- •(7\) Those who took oral steroids within 4 weeks of visit 1\.
- •(8\) Those who took dietary supplements related to sleep improvement within 4 weeks of visiting 1\.
Outcomes
Primary Outcomes
Not specified
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