Status:
COMPLETED
Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
Lead Sponsor:
Ewha Womans University
Conditions:
Healthy Adults With Subjective Sleep Complaints
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03337789
Start Date
November 7 2016
End Date
December 31 2017
Last Update
January 23 2018
Active Locations (1)
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1
Ewha Womans University
Seoul, South Korea, 03759