Clinical trial NCT03337789: Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
Official title: Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults With Subjective Sleep Complaints
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers who are between the ages of 20 and 65
* Experienced any of the following sleep problems, at least more than once a week for more than 2 months: 1) difficulty in falling asleep or staying asleep; 2) waking up at dusk and not being able to fall asleep again; 3) not feeling refreshed even after getting some sleep.

Exclusion Criteria:

* Diagnosed with insomnia assessed with a structured interview and sleep scale measurements
* Possibility of drug-induced sleep disorders due to current intake of medication (i.e., corticosteroid, statin, etc)
* Had taken sleeping pills (i.e., zolpidem, benzodiazepine) during the past 2 months
* Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests.
* Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, alcohol dependence, schizophrenia) evaluated with a structured instrument
* A history of traumatic brain injury with loss of consciousness, or any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in body)
* Had taken psychotropic drugs within the past 3 months before study participation
* Allergic to polygonatum sibiricum or experienced side effects after consumption of any product containing polygonatum sibiricum
* Participated in another clinical trial or took other medications during the period that may influence the results of this clinical trial
* Currently taking contraceptive pills
* Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding

Primary outcomes:
measure: Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index
timeFrame: Baseline and week 4
measure: Chagne from baseline physical activity at 4 weeks assessed by actigraph
timeFrame: Baseline and week 4
measure: Change from baseline objective sleep quality at 4 weeks assessed by polysomnography
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery
timeFrame: Baseline and week 4
measure: Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale
timeFrame: Baseline and week 4
measure: Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale
timeFrame: Baseline and week 4
measure: Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University
Study officials:
References: