UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032765 |
|---|---|
| Receipt number | R000037373 |
| Scientific Title | Examination of the usefulness of kangen-karyu in the metabolic syndrome patient |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/12/04 20:23:27 |
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Basic information
Public title
Examination of the usefulness of kangen-karyu in the metabolic syndrome patient
Acronym
Examination of the usefulness of kangen-karyu in the metabolic syndrome patient
Scientific Title
Examination of the usefulness of kangen-karyu in the metabolic syndrome patient
Scientific Title:Acronym
Examination of the usefulness of kangen-karyu in the metabolic syndrome patient
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We give kangen-karyu to metabolic syndrome patient for six months and examine clinical response
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate home blood pressure, degree of obesity , total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride , HbA1C, after taking kangen-karyu for six months
Key secondary outcomes
We evaluate subjective symptoms
"kitai", "oketu" after taking kangen-karyu for six months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the patient takes kangen-karyu 2.5g three times a day for six months
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who corresponds to diagnostic criteria of the metabolic syndrome.In addition, the patient whom it was judged an interview list to be a state of kitai, oketu
Key exclusion criteria
The patient who judged that a doctor was inappropriate
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Kitazawa |
Organization
Shinseikai Toyama Hospital
Division name
internal medicine
Zip code
939-0243
Address
89-10, Shimowaka, Imizu-shi
TEL
0766522156
kitazawa@shinseikai.or.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Kitazawa |
Organization
shinseikai toyama hospital
Division name
internal medicine
Zip code
939-0243
Address
89-10, Shimowaka, Imizu-shi
TEL
0766522156
Homepage URL
kitazawa@shinseikai.or.jp
Sponsor or person
Institute
shinseikai toyama hospital
Institute
Department
Personal name
Funding Source
Organization
ISUKURA industry Co., Ltd.
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
Shinseikai Toyama Hospital Kenkyu rinri shinsa iinkai
Address
89-10, Shimowaka, Imizu-shi
Tel
0766-52-2156
rinri@shinseikai.or.jp
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 | 07 | Month | 01 | 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
5
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
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037373
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
