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OpenTrials
Completed

NCT Number: NCT03337789

Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

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

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Key information

Conditions

Healthy Adults With Subjective Sleep Complaints

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University

Seoul, 03759, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polygonatum sibiricum

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index

    Time frame: Baseline and week 4

  2. Chagne from baseline physical activity at 4 weeks assessed by actigraph

    Time frame: Baseline and week 4

  3. Change from baseline objective sleep quality at 4 weeks assessed by polysomnography

    Time frame: Baseline and week 4

Secondary outcomes

  1. Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery

    Time frame: Baseline and week 4

  2. Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale

    Time frame: Baseline and week 4

    Scale name: Hamilton Depression Rating Scale

    / Range of total score: 0 - 52 (Higher scores represent more severe depressive symptoms.)

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

    Time frame: Baseline and week 4

    Scale name: Hamilton Anxiety Rating Scale

    / Range of total score: 0 - 56 (Higher scores represent more severe anxiety symptoms.)

  4. Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data

    Time frame: Baseline and week 4

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2017
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.