Status Approved
First Submitted Date
2018/01/29
Registered Date
2018/04/23
Last Updated Date
2018/03/23
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002821 |
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Unique Protocol ID | 136-21 |
Public/Brief Title | Lactuca sativa L and Scutellaria baicalensis for sleep improvement |
Scientific Title | Effects of the extract mixtures of Lactuca sativa L and Scutellaria baicalensis for sleep improvement: A prospective randomized double-blind placebo-controlled clinical trial |
Acronym | LS |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 136-21 |
Approval Date | 2017-07-31 |
Institutional Review Board Name | Ewha Womans University Institutional Review Board |
Institutional Review Board Address | 52, Ewhayeodae-gil, Seodaemun-gu, Seoul |
Institutional Review Board Telephone | 02-3277-7152 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jungyoon Kim |
Title | Assistant Professor |
Telephone | +82-2-3277-6555 |
Affiliation | Ewha Womens University |
Address | 52 Ewhayeodae-gil Seodaemoon-gu Seoul |
Contact Person for Public Queries | |
Name | Jungyoon Kim |
Title | Assistant Professor |
Telephone | +82-2-3277-6555 |
Affiliation | Ewha Womens University |
Address | 52 Ewhayeodae-gil Seodaemoon-gu Seoul |
Contact Person for Updating Information | |
Name | Jungyoon Kim |
Title | Assistant Professor |
Telephone | +82-2-3277-6555 |
Affiliation | Ewha Womens University |
Address | 52 Ewhayeodae-gil Seodaemoon-gu Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-08-24 Actual | |
Target Number of Participant | 86 | |
Primary Completion Date | 2018-07-30 , Anticipated | |
Study Completion Date | 2018-07-30 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Ewha Womens University | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-08-24 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Neo Cremar |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Ewha Womens University |
Organization Type | University |
7. Study Summary
Lay Summary | This study aims to investigate the efficacy and safety of the extract mixtures of Lactuca sativa L and Scutellaria baicalensis for sleep quality improvement. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator, Caregiver, Outcome Accessor |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | Extract mixtures of Lactuca sativa L and Scutellaria baicalensis or placebo 3 capsules (750mg x 3) per day, 60 minutes before sleep, once a day for 4 to 6 weeks |
Number of Arms | 2 |
Arm 1 |
Arm Label Lactuca sativa L and Scutellaria baicalensis |
Target Number of Participant 43 |
|
Arm Type Experimental |
|
Arm Description Extract mixtures of Lactuca sativa L and Scutellaria baicalensis 3 capsules (750mg x 3) per day, 60 minutes before sleep, once a day for 4 to 6 weeks |
|
Arm 2 |
Arm Label Placebo |
Target Number of Participant 43 |
|
Arm Type Placebo comparator |
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Arm Description Placebo, 3 capsules (750mg x 3) per day, 60 minutes before sleep, once a day for 4 to 6 weeks |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (G00-G99)Diseases of the nervous system (G47.0)Disorders of initiating and maintaining sleep [insomnias] |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~65Year |
|
Description - 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 based on ICD-10 and the PSQI scores or classified as having severe sleep apnea or periodic limb movement symptoms based on the polysomnography results. - Current intake of medication known to induce sleep disorders (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 Lactuca sativa L and/or Scutellaria baicalensis, or had experienced side effects after consumption of any product containing Lactuca sativa L and/or Scutellaria baicalensis - 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 |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Change from baseline subjective sleep quality at 4 weeks assessed by Pittsburgh Sleep Quality Index |
|
Timepoint | Baseline and week 4 |
|
Primary Outcome(s) 2 | ||
Outcome | Chagne from baseline physical activity at 4 weeks assessed by actigraph |
|
Timepoint | Baseline and week 4 |
|
Primary Outcome(s) 3 | ||
Outcome | Change from baseline objective sleep quality at 4 weeks assessed by polysomnography |
|
Timepoint | Baseline and week 4 |
|
Secondary Outcome(s) 1 | ||
Outcome | Change from baseline cognitive functions at 4 weeks assessed by the neuropsychological test battery |
|
Timepoint | Baseline and week 4 |
|
Secondary Outcome(s) 2 | ||
Outcome | Change from baseline depressive symptom levels at 4 weeks assessed by the Hamilton Depression Rating Scale |
|
Timepoint | Baseline and week 4 |
|
Secondary Outcome(s) 3 | ||
Outcome | Change from baseline anxiety symptom levels at 4 weeks assessed by the Hamilton Anxiety Rating Scale |
|
Timepoint | Baseline and week 4 |
|
Secondary Outcome(s) 4 | ||
Outcome | Change from baseline brain structure, function, and metabolism at 4 weeks assessed by computational analysis of magnetic resonance imaging data |
|
Timepoint | Baseline and week 4 |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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