Healthy Adults With Subjective Sleep ComplaintsNCT03337789
Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
A study testing Polygonatum sibiricum in people with Healthy Adults With Subjective Sleep Complaints, run by Ewha Womans University at 1 site in South Korea.
Trial summary
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults With Subjective Sleep Complaints
- What is being tested?
- Polygonatum sibiricum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
- Being tested
- Polygonatum sibiricum, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygonatum sibiricumDietary supplement
Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks
PlaceboDietary supplement
Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Polygonatum sibiricum | Experimental | Not described Receives: Dietary Supplement: Polygonatum sibiricum |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index
Measured: Baseline and week 4
Chagne from baseline physical activity at 4 weeks assessed by actigraph
Measured: Baseline and week 4
Change from baseline objective sleep quality at 4 weeks assessed by polysomnography
Measured: Baseline and week 4
Secondary outcomes (4)
Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery
Measured: 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.)
Measured: 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.)
Measured: Baseline and week 4
Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start7 Nov 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adults With Subjective Sleep ComplaintsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieun Kim, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337789
- Sponsor's protocol ID
- PSE
- Status last verified
- Jan 2018
- First submitted
- 6 Nov 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Polygonatum Sibiricum on Sleep Quality Improvement
- ClinicalTrials.gov ID
- NCT03337789
- Acronym / sponsor ID
- PSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- 7 Nov 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the efficacy and safety of Polygonatum sibiricum for sleep quality improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polygonatum sibiricum | Experimental | Dietary Supplement: Polygonatum sibiricum |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygonatum sibiricumPolygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks | Dietary supplement | Polygonatum sibiricum |
| PlaceboPlacebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index
Time frame: Baseline and week 4
Chagne from baseline physical activity at 4 weeks assessed by actigraph
Time frame: Baseline and week 4
Change from baseline objective sleep quality at 4 weeks assessed by polysomnography
Time frame: Baseline and week 4
4 secondary outcomes
Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery
Time frame: Baseline and week 4
Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale
Time frame: Baseline and week 4
Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale
Time frame: Baseline and week 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygonatum sibiricum in people with Healthy Adults With Subjective Sleep Complaints, run by Ewha Womans University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index (time frame: Baseline and week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.