Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

Not Applicable

Completed

• Conditions: Healthy Adults With Subjective Sleep Complaints
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Polygonatum sibiricum

• Registration Number: NCT03337789
• Lead Sponsor: Ewha Womans University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-07
• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-09
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-20
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Polygonatum sibiricum	Polygonatum sibiricum	-

Primary Outcome Measures

Name	Time	Method
Change from baseline objective sleep quality at 4 weeks assessed by polysomnography	Baseline and week 4
Chagne from baseline physical activity at 4 weeks assessed by actigraph	Baseline and week 4
Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index	Baseline and week 4

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ewha Womans University; 🇰🇷 Seoul, Korea, Republic of