UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034827 |
|---|---|
| Receipt number | R000039719 |
| Scientific Title | Effects of burdock sprout extract on decreasing LDL-cholesterol level; A single center double blind randomized controlled trial |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2021/09/27 14:50:21 |
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Basic information
Public title
Effects of burdock sprout extract on decreasing LDL-cholesterol level; A single center double blind randomized controlled trial
Acronym
Study for effects of burdock sprout extract on decreasing LDL-cholesterol level
Scientific Title
Effects of burdock sprout extract on decreasing LDL-cholesterol level; A single center double blind randomized controlled trial
Scientific Title:Acronym
Study for effects of burdock sprout extract on decreasing LDL-cholesterol level
Region
| Japan |
Condition
Condition
abnormal lipid metabolism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate effects of burdock sprout extract on decreasing LDL-cholesterol level and other factors such as triglyceride in the patients whose LDL-cholesterol level is higher than normal range even after nutritional guidance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in LDL-cholesterol level in the patients whose LDL-cholesterol level is higher than normal range at 12 weeks after taking burdock sprout extract.
Key secondary outcomes
Change of liver function, other kinds of serum lipid level, blood glucose level, and other cytokine and adipokine levels such as leptin and tumor necrosis factor-alpha in the patients whose LDL-cholesterol level is higher than normal range at 4 and 12 weeks after taking burdock sprout extract, and Fib-4 index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
burdock sprout extract (+)
Interventions/Control_2
burdock sprout extract (-)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. A patient whose total cholesterol level is over 230 mg/dL, or LDL-colesterol level is over140mg/dL
2. A patient who attended nutritional guidance 4 weeks or more before starting this study
Key exclusion criteria
1. A patient who is taking any drugs affecting lipid metabolism
2. A patient who cannot stop any supplements health food affecting lipid metabolism
3. A patient who is pregnant, or may become pregnant, or desire to get pregnant
4. A patient who has or had serious diseases in heart, liver, kidney, gastrointestinal tract, etc.
5. A patient who has allergy for any drugs or food
6. A patient who has or had drug or alcohol dependence
7. A patient who is judged to be unsuitable for this study by the doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Horie |
Organization
Shonan Keiiku Hospital
Division name
Internal Medicine
Zip code
252-0816
Address
4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
TEL
0466-48-0050
y-horie@keiiku.gr.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Miyazaki |
Organization
Shonan Keiiku Hospital
Division name
Office
Zip code
252-0816
Address
4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
TEL
0466-48-0050
Homepage URL
k-miyazaki@keiiku.gr.jp
Sponsor or person
Institute
Shonan Keiiku Hospital
Institute
Department
Personal name
Funding Source
Organization
Kracie Holdings Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University, Graduate School of Media and Governance
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan Keiiku Hospital
Address
4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
Tel
0466-48-0050
k-miyazaki@keiiku.gr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 09 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039719
