Status Approved
First Submitted Date
2021/01/08
Registered Date
2021/03/26
Last Updated Date
2021/03/23
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006032 |
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Unique Protocol ID | 2020008 |
Public/Brief Title | A multi-center, randomized, double-blind, and controlled a clinical study for improvement of bone health via the analysis of effect of ferment oyster extract. |
Scientific Title | A multi-center, randomized, double-blind, and controlled a clinical study for improvement of bone health via the analysis of effect of ferment oyster extract |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020008 |
Approval Date | 2020-03-10 |
Institutional Review Board Name | Pusan National University Korean Medicine Hospital Institutional Review Board |
Institutional Review Board Address | 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do |
Institutional Review Board Telephone | 055-360-5902 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | IN HEO |
Title | Professor |
Telephone | +82-55-360-5966 |
Affiliation | Pusan National University Korean Medicine Hospital |
Address | 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do |
Contact Person for Public Queries | |
Name | Hyun Tae Kim |
Title | KMD |
Telephone | +82-55-360-5966 |
Affiliation | Pusan National University Korean Medicine Hospital |
Address | 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do |
Contact Person for Updating Information | |
Name | Hyun Tae Kim |
Title | KMD |
Telephone | +82-55-360-5966 |
Affiliation | Pusan National University Korean Medicine Hospital |
Address | 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-04-05 Anticipated | |
Target Number of Participant | 120 | |
Primary Completion Date | 2021-12-31 , Anticipated | |
Study Completion Date | 2021-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Pusan National University Korean Medicine Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-04-05 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Dong-A University Hospital | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-04-05 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | MARINE BIOPROCESS |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Pusan National University Korean Medicine Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | This study investigated whether fermented oyster extract as a functional raw material for health functional food is safe and clinically and scientifically analyzed and evaluated whether there is an effect on health. The human application test was designed as a multi-center, double-blind, randomized, and control food comparison test. If the subject voluntarily agrees in writing to participate in the clinical trial, the subject's suitability is evaluated after performing the necessary examinations and tests in accordance with the human application trial plan, and the test according to a pre-generated random assignment only to those who meet the selection/exclusion criteria. Randomized 1:1 as a group control. Research subjects randomly assigned are given trial food and dosing diary, etc. Take it once daily according to the prescribed method. On days 0, 56, 112, and 168, the efficacy and safety endpoints are measured and tested, and the results are analyzed. |
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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 | Others (Fermented Oyster Extract) |
Intervention Description | Fermented oyster extract, 1,400mg/day, once a day, once a day 350mg 4 capsules, Take it with water after dinner |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental group |
Target Number of Participant 80 |
|
Arm Type Experimental |
|
Arm Description Fermented oyster extract, 1,400mg/day, once a day, once a day 350mg 4 capsules, Take it with water after dinner for 168 days (24 weeks) |
|
Arm 2 |
Arm Label Placebo comparator |
Target Number of Participant 80 |
|
Arm Type Placebo comparator |
|
Arm Description Dextrin, 1,400mg/day, once a day, once a day 350mg 4 capsules, Take it with water after dinner for 168 days (24 weeks) |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M81.09)Postmenopausal osteoporosis, site unspecified 1) Women over the age of 45 2) The next confirmed menopause ① Those who have passed more than 1 year after the last menstruation as of the screening date ② Natural amenorrhea or screening for 6 months based on the biochemical criteria for menopause (FSH> 40 IU) Received bilateral oophorectomy ≥ 6 weeks prior to visit. |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 45Year~No Limit |
|
Description 1) Women over the age of 45 2) The next confirmed menopause ① Those who have passed more than 1 year after the last menstruation as of the screening date ② Natural amenorrhea or screening for 6 months based on the biochemical criteria for menopause (FSH> 40 IU) Received bilateral oophorectomy ≥ 6 weeks prior to visit. |
|
Exclusion Criteria |
1) Those who received treatment such as Hormone replacement therapy, calcitonin, bisphosphonate within 6 months before screening test 2) Those who have been taking beta-adrenergic receptor inhibitors within 2 months prior to screening test 3) People with diabetes/hyperlipidemia that cannot be controlled within 2 months before screening test or People who take soy-containing health functional food 4) Within 2 months before the screening test, People who took herbal medicines (Ogapi, Hogol, Gokgisaeng, Sangsaeng) which can affect bone metabolism, treatments such as steroids (Dynol tablet, Edgol tablet, Won Alpha Tablet, Premina Tablet, Posteage, Preda Tablet). Those who have consumed healthy foods (soy isoflavone, black yeast culture powder, milk protein extract) which can affect bone metabolism, 5) People with liver disease or AST or ALT greater than twice the upper limit of normal 6) Patients with uncontrolled high blood pressure or heart disease such as angina pectoris-myocardial infarction 7) Patients with uncontrolled hyperthyroidism or hypothyroidism 8) Those who have taken other clinical trial drugs within 1 month 9) Those suffering from diseases affecting bone metabolism (cirrhosis/chronic renal failure/drug treatment Necessary anemia) 10) Patients with medically inappropriate administration of test food 11) Alcohol abuser 12) People with osteoporosis-related or other concomitant diseases that may affect the drug safety evaluation 13) Those who are being treated for psychiatric diseases 14) Others, those who are judged to be inappropriate by the judgment of the responsible researcher and the person in charge of testing |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | osteocalcin |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 1 | ||
Outcome | Deoxypyridinoline |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 2 | ||
Outcome | DPD/OSC ratio |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 3 | ||
Outcome | Bone Alkaline Phosphate |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 4 | ||
Outcome | Ca |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 5 | ||
Outcome | WOMAC |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 6 | ||
Outcome | C-telopeptide of type-I collagen |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 7 | ||
Outcome | N-telopeptide of type-I collagen |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 8 | ||
Outcome | BMD |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 9 | ||
Outcome | Estrogen |
|
Timepoint | 0, 168th day |
|
Secondary Outcome(s) 10 | ||
Outcome | Growth Hormone |
|
Timepoint | 0, 168th day |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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