Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

NCT03337789 | Completed

• 1 other identifier: PSE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults With Subjective Sleep Complaints

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale

  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

Study Arms (2)

Polygonatum sibiricum

EXPERIMENTAL

Dietary Supplement: Polygonatum sibiricum

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Polygonatum sibiricum DIETARY_SUPPLEMENT

Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks

Polygonatum sibiricum

Placebo DIETARY_SUPPLEMENT

Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha Womans University

Seoul, 03759, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 9, 2017
• Study Start: November 7, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

KR (1)