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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032765
Receipt No. 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 2019/11/29

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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
Email 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
Email kitazawa@shinseikai.or.jp

Sponsor
Institute shinseikai toyama hospital
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
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
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037373

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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