UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024028 |
|---|---|
| Receipt number | 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 | 2021/05/06 15:20:25 |
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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
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
jm-kouheij@kochi-u.ac.jp
Sponsor or person
Institute
Kochi medical school hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027631
