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The clinical study for the evaluation of the efficacy and safety of YY-312 on reducing body weight and body fat mass of obese Korean. : a 12 weeks, randomized, double-blind, placebo-controlled clinical trial

Status Approved

  • First Submitted Date

    2014/08/20

  • Registered Date

    2014/09/15

  • Last Updated Date

    2014/09/02

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
    KCT0001225
    Unique Protocol ID SIT-2013-335
    Public/Brief Title The clinical study for the evaluation of the efficacy and safety of YY-312(Herbal extract composition; Evodiae fructus, Imperatae rhizome and Citrus unshiu markovich) on reducing body weight and body fat mass of obese Korean. : a 12 weeks, randomized, double-blind, placebo-controlled clinical trial
    Scientific Title The clinical study for the evaluation of the efficacy and safety of YY-312 on reducing body weight and body fat mass of obese Korean. : a 12 weeks, randomized, double-blind, placebo-controlled clinical trial
    Acronym
    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 SIT-2013-335
    Approval Date 2013-10-25
    Institutional Review Board Name Inje University 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 Miyoung Lee
    Title M.D.
    Telephone +82-2-2270-0960
    Affiliation Inje University Seoul Paik Hospital
    Address
    Contact Person for Updating Information
    Name Miyoung Lee
    Title M.D.
    Telephone +82-2-2270-0960
    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 Active, not recruiting
    Date of First Enrollment 2014-04-08 Actual
    Target Number of Participant 60
    Primary Completion Date Anticipated
    Study Completion Date Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University Seoul Paik Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2014-04-08 ,
  • 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 Yuyu Pharma
    Organization Type Pharmaceutical Company
    Project ID SIT-2013-301
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yuyu Pharma
    Organization Type Pharmaceutical Company
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study will be a 12 weeks, douled blind, placebo-controlled, parallel group study of YY-312 demonstrated to reduce body weight in the previous studies of obese Korean for the evaluation of the efficacy and safety of body weight and body fat mass loss. 
    
    1. Primary endpoints 
    - Change in body fat percent and body fat mass by DEXA compared placebo and YY-312 from baseline at 12 weeks. 
    2. Secondary endpoints 
    - Change in body weight and body waist compared placebo and YY-312 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 YY-312 1,800mg or placebo. Subjects will orally self-adminster YY-312 1,800mg or placebo, 3 capsules twice per day for 12 weeks.  
    Number of Arms 2
    Arm 1

    Arm Label

    YY-312 1,800mg

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    Subjets will take orally self-administer YY-312 1,800mg, 3 capsules twice per day for 12weeks.  
    Arm 2

    Arm Label

    Placeo

    Target Number of Participant

    30

    Arm Type

    Placebo comparator

    Arm Description

    Subjets will take orally self-administer placebo, 3 capsules twice per day 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

    19Year~60Year

    Description

    1) Male and female subjects between 19-60years of age inclusive. 
    2) BMI of 25.0 - 30.0kg/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(Thyroid-Stimulating Hormone) value(≤0.1uU/ml or ≥10 uU/ml)
    4) Subjects with  hyperlipidemia) (fasting triglycerides > 600mg/dl)
    5) Serum AST(aminotransferse)/ALT(alanine amintransferse) ≥ 3 times the upper limit of normal
    6) Serum creatinine ≥ 1.5 times the upper limit of normal 
    7) Use of prescription drugs or supplements known to alter body weight or appetite, antidepressants, oral contraceptive, steroid, female sex hormon
    8) Subjects with taking drugs that can affect the body weight within the 3 months
    9) Subjects with clinically significant cardiovascular disease within the 6 months prior to screening
    10) Subjects who change weight more than 4kg within 4 months 
    11) Subjects with pancreatopathy 
    12) Subjects with chronic malabsorption syndrome or bile secretion disorder
    13) Subjects with undergoing gastrointestinal operation for reducing boy weight
    14) Subjects with postoperative intestinal adhesion 
    15) Subjects with a history of cancer and intervention within the 5 years prior to screening
    16) Subjects with a history of CNS(central nervous system) disorder(depressive disorder, schizophrenia, alcoholism, drug addiction)
    17) Subjects with heart disease, kidney disease, liver disease, lung disease and cerebrovascular disease
    18) Subjects with gallbladder diseases, gastrointestinal diseases, gout and porphyria
    19) Subjects with asthma and allergic disease 
    20) Subjects with bulimia and abuse of relievers
    21) Women of childbearing age who are disagreed with effective contraceptions in the clinical trial period
    22) Woman who are pregnant or lactating 
    23) Participation in any clinical trial within the 1 month prior to screening. 
    24) Subjects who could affect preclude evaluation 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
    Fat percentage(by DEXA)  
    Timepoint
    From baseline at 12 weeks  
    Primary Outcome(s) 2
    Outcome
    Fat mass(by DEXA)  
    Timepoint
    From baseline at 12 weeks  
    Secondary Outcome(s) 1
    Outcome
    Body weight
    Timepoint
    From baseline at 12 weeks  
    Secondary Outcome(s) 2
    Outcome
    Waist circumference 
    Timepoint
    From baseline at 12 weeks  
  • 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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