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
CRIS Registration Number |
KCT0001225 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Yuyu Pharma |
Organization Type | Pharmaceutical Company |
Project ID | SIT-2013-301 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yuyu Pharma |
Organization Type | Pharmaceutical Company |
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 |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Description Subjets will take orally self-administer placebo, 3 capsules twice per day for 12weeks. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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