UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014184 |
|---|---|
| Receipt number | R000016493 |
| Scientific Title | The effects of The Traditional Japanese Herbal Formulation Boiogito on postprandial glucose and lipid metabolism |
| Date of disclosure of the study information | 2014/06/06 |
| Last modified on | 2014/06/06 10:57:06 |
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Basic information
Public title
The effects of The Traditional Japanese Herbal Formulation Boiogito on postprandial glucose and lipid metabolism
Acronym
The effects of Boiogito on postprandial glucose and lipid metabolism
Scientific Title
The effects of The Traditional Japanese Herbal Formulation Boiogito on postprandial glucose and lipid metabolism
Scientific Title:Acronym
The effects of Boiogito on postprandial glucose and lipid metabolism
Region
| Japan |
Condition
Condition
healthy voluneteer
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Boiogito (BOT) is a common formulation in traditional Japanese medicine and has been used to treat various metabolic diseases, mostly in middle-aged obese women. We investigate the effects of BOT on postprandial glucose and fat metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Eleven healthy volunteers (5 women and 6 men; age range, 25-61 years) were enrolled in this open pilot trial. The participants were given BOT (7.5 g/day) for 2 weeks, after which they were given a test meal and 200 ml of cold water containing 100 mg of [1-13C]-glucose. Breath samples were collected every 10 min for 180 min.13C activity in breath samples was measured and glucose oxidation rate was calculated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Boiogito administration
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
| 25 | years-old | <= |
Age-upper limit
| 61 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
those had not used medicines in the 6 months before the start of this study.
Key exclusion criteria
those had used medicines in the 6 months before the start of this study
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Koichiro |
Organization
Toho University
Division name
Faculty of Medicine
Zip code
Address
Omorinishi5-21-16 Ota-ku, Tokyo
TEL
03-3762-4151
ktanaka1014@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanaka Koichiro |
Organization
Toho University
Division name
Faculty of Medicine
Zip code
Address
Omorinishi5-21-16 Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
ktanaka1014@hotmail.co.jp
Sponsor or person
Institute
Toho University, Faculty of Medicine, Department of Japanese traditional medicine
Institute
Department
Personal name
Funding Source
Organization
Toho University, Faculty of Medicine, Department of Japanese traditional medicine
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
| 2014 | Year | 06 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2014 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016493
| Research Plan | |
|---|---|
| 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 |
