Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

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

Study Overview

• Status: Completed
• Conditions: Healthy Adults With Subjective Sleep Complaints
• Intervention / Treatment: Dietary supplement: Polygonatum sibiricum; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03759
    • Ewha Womans University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks
Experimental: Polygonatum sibiricum	Dietary supplement: Polygonatum sibiricum; Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ewha Womans University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 20, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PSE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No