UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023186 |
|---|---|
| Receipt number | 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 09:10:34 |
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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
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
chiken@matsuyama.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Matsuyama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026728
