Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.

Official Title
-----------------
Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

Conditions
-----------------
Healthy Adults With Subjective Sleep Complaints

Intervention / Treatment
-----------------
* Dietary Supplement: Polygonatum sibiricum
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polygonatum sibiricum<br> | Dietary Supplement: Polygonatum sibiricum<br>* Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index |  | Baseline and week 4 | 
| Chagne from baseline physical activity at 4 weeks assessed by actigraph |  | Baseline and week 4 | 
| Change from baseline objective sleep quality at 4 weeks assessed by polysomnography |  | Baseline and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery |  | Baseline and week 4 | 
| Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale | Scale name: Hamilton Depression Rating Scale / Range of total score: 0 - 52 (Higher scores represent more severe depressive symptoms.) | Baseline and week 4 | 
| Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale | Scale name: Hamilton Anxiety Rating Scale / Range of total score: 0 - 56 (Higher scores represent more severe anxiety symptoms.) | Baseline and week 4 | 
| Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data |  | Baseline and week 4 |