Status Approved
First Submitted Date
2020/01/17
Registered Date
2020/01/30
Last Updated Date
2020/01/17
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0004672 |
|---|---|
| Unique Protocol ID | KHNMC 2017-06-030 |
| Public/Brief Title | Double blind, randomized controlled study to evaluate the efficacy and safety of extract of leaves of Dendropanax morbiferous H. Lev on the glucose metabolism |
| Scientific Title | Double blind, randomized controlled study to evaluate the efficacy and safety of extract of leaves of Dendropanax morbiferous H. Lev on the glucose metabolism |
| 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 |
|---|---|
| Board Approval Number | KHNMC 2017-06-030 |
| Approval Date | 2018-03-19 |
| Institutional Review Board Name | Institutional Review Board of Kyung Hee University Hospital at Gangdong |
| Institutional Review Board Address | 892, Dongnam-ro, Gangdong-gu, Seoul |
| Institutional Review Board Telephone | 02-440-8107 |
| Data Monitoring Committee |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | in-kyung jeong |
| Title | Professor |
| Telephone | +82-2-440-7058 |
| Affiliation | Kyung Hee University Hospital at Gangdong |
| Address | 892, Dongnam-ro,Gangdong-gu, Seoul |
| Contact Person for Public Queries | |
| Name | junghwa lee |
| Title | coordinator |
| Telephone | +82-2-440-7058 |
| Affiliation | Kyung Hee University Hospital at Gangdong |
| Address | 892, Dongnam-ro,Gangdong-gu, Seoul |
| Contact Person for Updating Information | |
| Name | junghwa lee |
| Title | coordinator |
| Telephone | +82-2-440-7058 |
| Affiliation | Kyung Hee University Hospital at Gangdong |
| Address | 892, Dongnam-ro,Gangdong-gu, Seoul |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2018-07-23 Actual | |
| Target Number of Participant | 80 | |
| Primary Completion Date | 2019-04-25 , Actual | |
| Study Completion Date | 2019-06-13 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Kyung Hee University Hospital at Gangdong | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2018-07-23 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | J-Creation |
| Organization Type | Others |
| Project ID | |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Kyung Hee University Hospital at Gangdong |
| Organization Type | Medical Institute |
7. Study Summary
| Lay Summary | Background: Dendropanax morbiferous H. Lev has already conducted several studies as follows: 1) blood circulation improvement, 2) liver function improvement, 3) antioxidant effect, 4) hard tissue bone and tooth regeneration effect, 5) immunity enhancement effect, 6) neurostable effect, 7 Antimicrobial and antimicrobial effects 8) Cancer cell proliferation Inhibitors have been reported to have a variety of effects, but the effect on improving blood glucose in humans has not been studied yet. Therefore, the purpose of this study is to evaluate the effects and safety of Dendropanax morbiferous H. Lev extracts on blood sugar reduction. METHODS: A randomized randomized group of 40 subjects in each group were treated with Dendropanax morbiferous H. Lev extract and placebo in a ratio of 1: 1, followed by daily doses of Hwangchil leaf extract or placebo for 3 months. Compare the measured HOMA-IR and HOMA-beta values. |
|---|
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 | The ratio of 1: 1 to leaves of Dendropanax morbiferous H. Lev extract group and placebo group is randomly assigned to each group, and to take Hwangchil-tree leaf extract or placebo every day for 3 months. Take 2 tablets once a day or once a day. |
| Number of Arms | 2 |
| Arm 1 |
Arm Label leaves of Dendropanax morbiferous H. Lev |
|
Target Number of Participant 40 |
|
|
Arm Type Experimental |
|
|
Arm Description The dose of Hwangchil-tree leaf extract is administered 700 mg per day, and two tablets are administered once a day before breakfast. |
|
| Arm 2 |
Arm Label placebo |
|
Target Number of Participant 40 |
|
|
Arm Type Placebo comparator |
|
|
Arm Description Two tablets made of 91% crystalline cellulose, 3% Hydroxypropyl MethylCellulse (HPMC), 2% silicon dioxide, 2% magnesium stearate, and 2% food coloring are administered before breakfast. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E74.1)Disorders of fructose metabolism A person without diabetes |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 21Year~75Year |
|
|
Description 1) 80 male and female adults aged 21 to 75 years without diabetes with fasting blood glucose levels below 126 mg / dl and glycated hemoglobin less than 6.5% ２) Person who has not received drug treatment for obesity and diabetes in the last three months 3) The person who voluntarily agreed to participate in this clinical trial |
|
| Exclusion Criteria |
1) Fasting blood glucose is 126 mg / dl or more or HbA1C 6.5% or more 2) Those who are taking drugs or dietary supplements for diabetes within the last three months and during clinical trials 3) Mental illnesses that may affect subject evaluation and investigational drugs. In particular, history such as mental disorder, depression 4) Except where the following laboratory test results are shown, which may affect the performance of the test. AST (SGOT) / ALT (SGPT) is a liver disease that is more than three times the normal upper limit -Renal impairment with creatinine levels above 1.5 mg / dl ５) Those who have been taking glucocorticoids that affect blood sugar within the last 3 months ６) Drug abuser or historical person (including alcohol) 7) History of serious illness that can recur during or immediately after clinical trials 8) Those who need treatment due to hyperthyroidism or hypothyroidism. (However, hypothyroidism that does not require treatment with a TSH of less than 10 μg / dl is not applicable.) In addition, persons deemed impossible to participate in clinical research by researchers |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | /Safety/Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Compare glucose changes |
|
| Timepoint | Screening, 3 months |
|
| Primary Outcome(s) 2 | ||
| Outcome | Compare insulin changes |
|
| Timepoint | Screening, 3 months |
|
| Primary Outcome(s) 3 | ||
| Outcome | Compare c-peptide changes |
|
| Timepoint | Screening, 3 months |
|
| Primary Outcome(s) 4 | ||
| Outcome | Changes in HOMA-IR Measured with Fasting Glucose and Insulin |
|
| Timepoint | Screening, 3 months |
|
| Primary Outcome(s) 5 | ||
| Outcome | Changes in HOMA-beta Measured with Fasting Glucose and Insulin |
|
| Timepoint | Screening, 3 months |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Comparison of Changes in Glycoalbumin |
|
| Timepoint | Screening,1 months , 3 months |
|
| Secondary Outcome(s) 2 | ||
| Outcome | Comparison of Changes in HbA1C |
|
| Timepoint | Screening,1 months , 3 months |
|
| Secondary Outcome(s) 3 | ||
| Outcome | Comparison of Changes in Weight Change |
|
| Timepoint | Screening, 1 month, 3 months |
|
| Secondary Outcome(s) 4 | ||
| Outcome | Comparison of changes in body fat |
|
| Timepoint | Screening, 1 month, 3 months |
|
| Secondary Outcome(s) 5 | ||
| Outcome | Comparison of waist circumference |
|
| Timepoint | Screening, 1 month, 3 months |
|
| Secondary Outcome(s) 6 | ||
| Outcome | Comparison of Total Cholesterol Change |
|
| Timepoint | Screening, 1 month, 3 months |
|
| Secondary Outcome(s) 7 | ||
| Outcome | Comparison of Triglyceride Changes |
|
| Timepoint | Screening, 1 month, 3 months |
|
| Secondary Outcome(s) 8 | ||
| Outcome | Comparison of LDL-C |
|
| Timepoint | Screening, 1 month, 3 months |
|
| Secondary Outcome(s) 9 | ||
| Outcome | Comparison of LDL-C |
|
| Timepoint | Screening, 1 month, 3 months |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | No |
|---|
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