UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013683 |
|---|---|
| Receipt number | R000015973 |
| Scientific Title | An open-labeled preliminary study of the effect of Peucedanum japonicum Thunb (PJT) ingestion on serum adiponectin secretion for healthy volunteer subjects |
| Date of disclosure of the study information | 2014/04/12 |
| Last modified on | 2014/04/10 17:20:05 |
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Basic information
Public title
An open-labeled preliminary study of the effect of Peucedanum japonicum Thunb (PJT) ingestion on serum adiponectin secretion for healthy volunteer subjects
Acronym
An open-labeled preliminary study of the effect of PJT ingestion on serum adiponectin secretion for healthy volunteer subjects
Scientific Title
An open-labeled preliminary study of the effect of Peucedanum japonicum Thunb (PJT) ingestion on serum adiponectin secretion for healthy volunteer subjects
Scientific Title:Acronym
An open-labeled preliminary study of the effect of PJT ingestion on serum adiponectin secretion for healthy volunteer subjects
Region
| Japan |
Condition
Condition
healthy volunteer subjects
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether PJT produced in Tokuno-shima island, is an adiponectin secretion-enhancing food factor or not in healthy volunteer people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the amount of serum adiponectin secretion
Key secondary outcomes
body weight and abdominal circumference
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
1,260 mg/day of a PJT tablet products for 3 months (Tyojusyokuzai-kenkyusyo, Tokyo, Japan)
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
| 47 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. to be simple obese subjects with over 20kg/m2 of BMI
2. to be the subjects over 20 years old on informed consent before entering the study
3. to be the subjects who gave their written informed consent before entering the study
Key exclusion criteria
1. to be the subjects with severe abnormalites of liver or kidney functions
2. to be the subjects allergic to PJT ingredients
3. to be the subjects in pregnancy or breast feeding
4. to be the subjects inadequate to participate in this trial, judged by the responsible physicians
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Maeda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary & Alternative Medicine
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka, 565-0871, Japan
TEL
06-6879-3498
kaz@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sawako Sawa |
Organization
Isen-tyo community health center
Division name
Isen-tyo community health center
Zip code
Address
2575-2, Isen, Isen-cho Oshima-gun, Kagoshima, 891-8201, Japan
TEL
0997-86-2124
Homepage URL
isen-ph@po5.synapse.ne.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of 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 | 04 | Month | 12 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2014 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015973
