UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003528 |
|---|---|
| Receipt number | R000004281 |
| Scientific Title | The efficacy and safety of Kampo (Japanese herbal) medicine, bofutsushosan, on matabolic syndrome -a randomized, double-blind, placebo-controlled trial- |
| Date of disclosure of the study information | 2010/04/24 |
| Last modified on | 2013/04/25 18:46:19 |
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Basic information
Public title
The efficacy and safety of Kampo (Japanese herbal) medicine, bofutsushosan, on matabolic syndrome -a randomized, double-blind, placebo-controlled trial-
Acronym
The efficacy and safety of bofutsushosan on matabolic syndrome
Scientific Title
The efficacy and safety of Kampo (Japanese herbal) medicine, bofutsushosan, on matabolic syndrome -a randomized, double-blind, placebo-controlled trial-
Scientific Title:Acronym
The efficacy and safety of bofutsushosan on matabolic syndrome
Region
| Japan |
Condition
Condition
metabolic syndrome
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether bofutsushosan is useful for metabolic syndrome and which condition affects its usefulness from the viewpoint of Kampo medicine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
body weight after 6-month administration
Key secondary outcomes
abdominal circumference, blood pressure, HDL, LDL, TG, HbA1c, FBS, HOMA-IR, hs-CRP, CAVI, S100A12, adiponectin, TNF-alfa, and SF-36 after 6-month administration and adverse events during the test period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
27 extract tablets of bofutsushosan manufactured by Kracie Pharmaceutical Ltd. per day, in 3 divided doses before or between meals, during 6 months
Interventions/Control_2
27 placebo tablets per day, in 3 divided doses before or between meals, during 6 months
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
Both A and B are required
A: abdominal circumference: 85 cm or over in men and 90 cm or over in women
B: one or more requirements below shold be met
1.[TG: 150mg/dl or over] and/or [HDL 40mg/dl or over]
2.[systolic blood pressure: 130mmHg or over] and/or [diastorlic blood pressure: 85mmHg or over]
3.fasting blood glucose: 110mg/dl or over
Key exclusion criteria
1.those who are taking Kampo drugs
2.those who have taken Kampo drugs in the past 4 weeks
3.those who need the treatment by conventional medicine
4.those who present significant liver or renal dysfunction
5.those who are taking the drugs affecting abdominal circumference or body weight
6.those who are taking antihyperlipidemic agents, antihypertensive agents, or antihyperglycemic agents
7.those with malignancy or heart failure which affects their general condition
8.those judged unsuitable for the trial by physician-in-charge
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Odaguchi |
Organization
Oriental Medicine Research Center, Kitasato University
Division name
Center for Evidence-Based Medicine
Zip code
Address
5-9-1, Shirokane, Minatoku, Tokyo
TEL
03-3444-6161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Odaguchi |
Organization
Oriental Medicine Research Center, Kitasato University
Division name
Center for Evidence-Based Medicine
Zip code
Address
5-9-1, Shirokane, Minatoku, Tokyo
TEL
03-3444-6161
Homepage URL
Sponsor or person
Institute
Oriental Medicine Research Center, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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
北里大学東洋医学総合研究所
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 24 | 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
| 2009 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 24 | Day |
Last modified on
| 2013 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004281
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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