Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement

NCT ID: NCT03337789

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Adults With Subjective Sleep Complaints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Polygonatum sibiricum

Group Type EXPERIMENTAL

Polygonatum sibiricum

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Polygonatum sibiricum

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Jieun Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ewha Womans University

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PSE

Identifier Type: -

Identifier Source: org_study_id

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