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A week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Fingerroot(Bosenbergia pandurata) 300mg and 600mg on reducing body weight and body fat of obese subjects

Status Approved

  • First Submitted Date

    2012/04/09

  • Registered Date

    2012/04/30

  • Last Updated Date

    2013/08/12

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
    KCT0000424
    Unique Protocol ID SIT-2012-074
    Public/Brief Title A week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Fingerroot(Bosenbergia pandurata) 300mg and 600mg on reducing body weight and body fat of obese subjects
    Scientific Title A week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Fingerroot(Bosenbergia pandurata) 300mg and 600mg on reducing body weight and body fat of obese subjects
    Acronym
    MFDS Regulated Study Yes
    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 SIT-2012-074
    Approval Date 2012-03-29
    Institutional Review Board Name Seoul Paik Hospital Institutional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee
  • 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 Jae Heon Kang
    Title Ph. D.
    Telephone +82-2-2270-0960
    Affiliation Inje University Seoul Paik Hospital
    Address
    Contact Person for Public Queries
    Name Yangim Hur
    Title M.D
    Telephone +82-2-2270-0907
    Affiliation Inje University Seoul Paik Hospital
    Address
    Contact Person for Updating Information
    Name Miyoung Lee
    Title M.D.
    Telephone +82-2-2270-0907
    Affiliation Inje University Seoul Paik Hospital
    Address
  • 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 2012-04-17 Actual
    Target Number of Participant 150
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University Seoul Paik Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2012-04-17 ,
  • 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 Newtree
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Newtree
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study will be a 12 weeks, douled blind, placebo-controlled, parallel group study of Fingerroot(Bosenbergia pandurata) for assessmenet of weight loss, body fat mass and fat percentage loss. This study will suggest the optimal intake and intake method and also will be based on a commercialization after acquired product-specific health functional food ingredients recognition and approval from KFDA(Korean Food & Drug Administration).1.Primary endpoints :Change in body weight at 4 weeks, 8 weeks, and 12 weeks
    :Change of fat mass(kg), fat percentage(%) by DEXA from baseline at 12 weeks. 2.Secondary endpoints :The Comparison of safety for efficacy, adverse event(AE) clinical laboratory on the changes visceral fat, subcutaneous fat(by CT), and waist circumference from baseline at 12 weeks. 
  • 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
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    Subjects will be randomized to receive Fingerroot(Bosenbergia pandurata) 300mg, 600mg or placebo. Subjets will orally self-adminster Fingerroot(Bosenbergia pandurata) 300mg, 600mg or placebo qd, 4 tablets per a day for 12weeks. 
    Number of Arms 3
    Arm 1

    Arm Label

    Fingerroot(Bosenbergia pandurata) 300mg

    Target Number of Participant

    50

    Arm Type

    Experimental

    Arm Description

    Subjets will take orally self-administer Fingerroot(Bosenbergia pandurata) 300mg qd, for 12weeks. 
    Arm 2

    Arm Label

    Fingerroot(Bosenbergia pandurata) 600mg

    Target Number of Participant

    50

    Arm Type

    Experimental

    Arm Description

    Subjets will take orally self-administer Fingerroot(Bosenbergia pandurata) 600mg qd, for 12weeks. 
    Arm 3

    Arm Label

    Placeo

    Target Number of Participant

    50

    Arm Type

    Placebo comparator

    Arm Description

    Subjets will take orally self-administer placebo qd, for 12weeks. 
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~65Year

    Description

    1) Male and female subjects between 20-65years of age inclusive.
    2) BMI of 25.0-29.9kg/m2 
    3) Evidense of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. 
    Exclusion Criteria
    1. Subjects with systolicBP ≥ 160 mmHg or diastolicBP ≥ 100 mmHg and also taking a beta blocker or a hydragogue.
    2. Subjects with diabetes(use of hypoglycemic agent or insulin)or fasting blood glucose ≥ 126 mg/dL or random blood glucose ≥ 200 mg/dL.
    3. Subjects with endocrinopathy or abnormal screening TSH value(≤0.1uU/ml or ≥10 uU/ml).
    4. Serum AST/ALT ≥ 3 times the upper limit of normal. 
    5. Serum creatinine ≥ 2 times the upper limit of normal. 
    6. Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon. 
    7. Subjets with clinically significant cardiovascular disease within the 6 months prior to screening. 
    8. Subjets with a history of cancer and intervention within the 5 years prior to screening. 
    9. Subjects with a history of CNS disorder(depressivedisorder,schizophrenia, alcoholism, drug addiction).
    10. Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period. 
    11. Woman who are pregnant or lactating. 
    12. Participation in any clinical trial within the 3 months prior to screening. 
    13. Subjects with bleeding risk factor of stomach.
    14. Subjects with the musculoskeletal disorders or restricted physical activity.
    15. Subjects who could affect preclude evauation of response in the opinion investigator. 
    
    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 Efficacy
    Primary Outcome(s) 1
    Outcome
    Change in body weight 
    Timepoint
    From baseline at 12 weeks 
    Primary Outcome(s) 2
    Outcome
    Chainge in fat percentage(by DEXA) 
    Timepoint
    From baseline at 12 weeks 
    Primary Outcome(s) 3
    Outcome
    Chainge in fat mass(by DEXA) 
    Timepoint
    From baseline at 12 weeks 
    Secondary Outcome(s) 1
    Outcome
    Change in visceral fat(by CT) 
    Timepoint
    From baseline at 12weeks 
    Secondary Outcome(s) 2
    Outcome
    Change in subcutaneous fat(by CT) 
    Timepoint
    From baseline at 12weeks 
    Secondary Outcome(s) 3
    Outcome
    Change in waist circumference 
    Timepoint
    From baseline at 12weeks 
  • 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
  • 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 Not provided at time of Registration
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