UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023186
Receipt No. R000026728
Scientific Title Research on the effectiveness of collagen tripeptide that target arterial sclerosis
Date of disclosure of the study information 2016/07/20
Last modified on 2019/01/16

* 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
Public title Research on the effectiveness of collagen tripeptide that target arterial sclerosis
Acronym Research on the effectiveness of collagen tripeptide that target arterial sclerosis
Scientific Title Research on the effectiveness of collagen tripeptide that target arterial sclerosis
Scientific Title:Acronym Research on the effectiveness of collagen tripeptide that target arterial sclerosis
Region
Japan

Condition
Condition Arteriosclerosis
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The CTP was orally administered to arterial sclerosis patient, reveal the impact on the arteriosclerosis index.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) blood lipid
2) ABI inspection
3) PWV inspection
4) carotid artery echo
5) liver function tests
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 6 months
Interventions/Control_2 Once a day, the CTP tablet 16 tablets orally taken with a glass of water or lukewarm water cup at dinner (can be any of the pre-meal, after a meal).
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. This study to understand, there is the ability to comply with it who
2. Prior to participation in the study, those who consent by the document can be obtained
3. Hyperlipidemia, or hypertension, or who have been diagnosed with both its
Key exclusion criteria 1.Those who study doctor was ineligible as an object of the present study
2. Those of type 1 or type 2 diabetes
3. A person suspected of cerebral infarction with paralysis
Four. Acute coronary syndrome, unstable angina, acute myocardial infarction, a person with a history of acute cerebral infarction and transient ischemic attack
Five. Patients with cancer
6. Hypothyroidism, the person suspected of Graves' disease
7. A person suspected of liver disease, including hepatitis virus persistent infection
8. Persons with renal disease severe
9. A person who has a liver disorder of severe
10. Who during pregnancy and lactation
11. Patient in hospital
12. It is under ingestion other health supplements, functional foods, those who can not stop eating during the test
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Okada
Organization Saiseikai Matsuyama Hospital
Division name Internal medicine
Zip code
Address Matsuyama, Ehime Prefecture Shanxi-cho, 880-2
TEL 089-951-6111
Email chiken@matsuyama.saiseikai.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Shimizu
Organization Saiseikai Matsuyama Hospital
Division name Clinical trial management office
Zip code
Address Matsuyama, Ehime Prefecture Shanxi-cho, 880-2
TEL 089-951-6164
Homepage URL
Email chiken@matsuyama.saiseikai.or.jp

Sponsor
Institute Saiseikai Matsuyama Hospital
Institute
Department

Funding Source
Organization Saiseikai Matsuyama Hospital
Organization
Division
Category of Funding Organization Self funding
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 07 Month 20 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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 21 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 15 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.