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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024028
Receipt No. R000027631
Scientific Title Clinical trials of the lipid improvement effect of Goishi tea evaluated by index LDL cholesterol
Date of disclosure of the study information 2016/09/14
Last modified on 2016/11/14

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Basic information
Public title Clinical trials of the lipid improvement effect of Goishi tea evaluated by index LDL cholesterol
Acronym Clinical trials of lipid improvement effect of Goishi tea
Scientific Title Clinical trials of the lipid improvement effect of Goishi tea evaluated by index LDL cholesterol
Scientific Title:Acronym Clinical trials of lipid improvement effect of Goishi tea
Region
Japan

Condition
Condition Healthy individual
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the LDL lowering effect of the intake of Goishi tea
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL-CHO
Key secondary outcomes Height,Weight, Blood pressure,
T-CHO,HDL-CHO,TP,T-BIL,UN,CRE,UA,ALT,AST,
alpha-GTP,ALP,LD,CK,ChE,AMY,Na, K,Cl,Ca,
Fe,Blood sugar,HbA1c,CBC

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 NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The subjects drink 195g (about 195mL) Goishi tea twice a day for 12 weeks.
Interventions/Control_2 The subjects drink 195g (about 195mL) placebo twice a day for 12 weeks.
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. Healthy adults
2. If you sign a consent document, you will be in 65 years or less, and 20 years of age or older
3. The person who have pointed out that high cholesterol in the past year, and who recommended a diet and exercise therapy
4. If LDL cholesterol value of screening tests is greater than or equal to 120mg / dL
Key exclusion criteria 1. Minors
2. Maternal and lactating women
3. The person who is suffering from some sort of disease
4. The person who drink on a daily basis Goishi tea
5. The person principal investigator has determined that inappropriate
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Miyamura
Organization Kochi medical school hospital
Division name pharmacy
Zip code
Address 185-1, Kohasu, Oko, Nankoku, Kochi, Japan
TEL 088-880-2549
Email miyamus@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Jobu
Organization Kochi medical school hospital
Division name pharmacy
Zip code
Address 185-1, Kohasu, Oko, Nankoku, Kochi, Japan
TEL 088-880-2549
Homepage URL
Email jm-kouheij@kochi-u.ac.jp

Sponsor
Institute Kochi medical school hospital
Institute
Department

Funding Source
Organization Otoyo yutori farm
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 Month 14 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 Open public recruiting
Date of protocol fixation
2016 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 13 Day
Last modified on
2016 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027631

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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