Efficacy of LTC-022 on Sleep Improvement

Not Applicable

Recruiting

• Conditions: Diseases of the nervous system

• Registration Number: KCT0007750
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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.
(9) Those who are sensitive or allergic to the ingredients of the clinical trial (those with hypersensitivity to milk and dairy products).
(10) Those with body mass index (BMI) 30 kg/m2 or higher at visit 1.
(11) Those with alcohol use disorder and who are being treated by hospitalization, medications, or rehabilitation.
(12) Those with irregular sleep patterns within 4 weeks due to the shift or night work at visit 1.
(13) 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.
(14) Those who are pregnant, lactating women, or planning pregnancy during the clinical trial period.
(15) Those who determined to be not appropriated to participate for other reason by the investigators.

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)

Secondary Outcome Measures

Name	Time	Method
KESS(Korean Version of Epworth Sleepiness Scale);sleep diary and sleep log by Fitbit;Health-related quality of life(SF-12, mibyeong);Blood Biomarker;Fecal microbiome;Heart Rate Variability test;ISI-K(Korean Version of Insomnia Severity Index)