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Effects of the extract mixtures of Lactuca sativa L and Scutellaria baicalensis for sleep improvement: A prospective randomized double-blind placebo-controlled clinical trial

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002821
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific 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 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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Neo Cremar
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Ewha Womens University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    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

    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

    Subject Eligibility Information
    Condition(s)/Problem(s) * (G00-G99)Diseases of the nervous system 
       (G47.0)Disorders of initiating and maintaining sleep [insomnias] 
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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