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
CRIS Registration Number |
KCT0000424 |
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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
Board Approval Status | Submitted approval |
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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 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 | 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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Newtree |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Newtree |
Organization Type | Others |
7. Study Summary
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. |
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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 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
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 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)
Type of Primary Outcome | Efficacy | |
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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
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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