UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034827
Receipt No. R000039719
Official scientific title of the study 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 2018/11/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Effects of burdock sprout extract on decreasing LDL-cholesterol level; A single center double blind randomized controlled trial
Title of the study (Brief title) 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 body weight, 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 Yoshinori Horie
Organization Shonan Keiiku Hospital
Division name Internal Medicine
Address 4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
TEL 0466-48-0050
Email y-horie@keiiku.gr.jp

Public contact
Name of contact person Kenji Miyazaki
Organization Shonan Keiiku Hospital
Division name Office
Address 4360 Endo Fujisawa-shi Kanagawa-ken, 252-0816, Japan
TEL 0466-48-0050
Homepage URL
Email k-miyazaki@keiiku.gr.jp

Sponsor
Institute Shonan Keiiku Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 08 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 09 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.