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
Status :
Approved
First Submitted Date : 2014/08/20
Registered Date : 2014/09/15
Last Updated Date : 2014/09/02
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
1. Background
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
Institutional Review Board Information - Clinical research ethics review consisting of approval status, approval number, approval date, committee information, and data monitoring committee.
2. Institutional Review Board/Ethics Committee
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
Contact Details Information - Contact Details Information consisting of Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Name of Contact Person for Updating Information, Title, Email, Telephone, Cellular Phone, Affiliation, Address.
3. Contact Details
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
Status Information - Status Information consisting of 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.
4. Status
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
,
Source of Monetary / Material Support Information - Source of Monetary / Material Support Information consisting of Organization Name, Organization Type, Project ID.
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support
Organization Name
Yuyu Pharma
Organization Type
Pharmaceutical Company
Project ID
SIT-2013-301
Sponsor Organization Information - Sponsor Organization Information consisting of Organization Name, Organization Type.
6. Sponsor Organization
1. Sponsor Organization
Organization Name
Yuyu Pharma
Organization Type
Pharmaceutical Company
Study Summary Information
7. Study Summary
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
Study Design Information - Study Design Information consisting of 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.
8. Study Design
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.
Subject Eligibility Information
9. Subject Eligibility
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
Outcome Measure(s) Information - Outcome Measure(s) Information consisting of Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint.
10. Outcome Measure(s)
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
Study Results and Publication Information - Study Results and Publication Information consisting of Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary.
11. Study Results and Publication
Result Registered
Sharing of Study Data Information - Sharing of Study Data Information consisting of Sharing Statement, Time of Sharing, Way of Sharing.
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)