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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013876
Receipt No. R000016184
Scientific Title A pilot study about the efficacy of Angelica keiskei for the morbid obese patients screened with their own adipose derived stem cell.
Date of disclosure of the study information 2014/05/07
Last modified on 2017/11/06

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Basic information
Public title A pilot study about the efficacy of Angelica keiskei for the morbid obese patients screened with their own adipose derived stem cell.
Acronym A pilot study about the efficacy of the supplements based on ADSC screening.
Scientific Title A pilot study about the efficacy of Angelica keiskei for the morbid obese patients screened with their own adipose derived stem cell.
Scientific Title:Acronym A pilot study about the efficacy of the supplements based on ADSC screening.
Region
Japan

Condition
Condition Morbid obesity
Classification by specialty
Endocrinology and Metabolism Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We verify that the supplements have the effect of increasing blood adiponectin level in vivo, which effect is confirmed in vitro.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Adiponectin
Key secondary outcomes Blood lipids
Nutritional indicators
Body composition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 We collect the surplus adipose cell during sleeve gastorectomy in patients with morbid obesity.
After the culture, Angelica keiskei is added to adipose-derived stem cell.
Adiponectin increasing effect is observed:1
Adiponectin increasing effect is not observed:2
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The case of 1: Randomized and divided into 2 groups.
Effective and supplement intake group:5 people
Subjects take two pouch of Angelica keiskei supplements per a day for 6 month.
Each evaluations are performed every two month.
Interventions/Control_2 Same as interventions 1
******************************************
The result of interventions 2, subjects who are assigned to non-intervention belongs to the group below.
Effective and non-intervention group:5 people
Each evaluations are performed every two month.
No intakes of supplements.
Interventions/Control_3 Same as interventions 1
******************************************
Subjects of 2
Not effective and non-intervention group:5 people
Each evaluations are performed every two month.
No intakes of supplements.
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 1) Morbid Obese patients who were performed Sleeve gastrectomy.
2) Patients expected over 3 month-survival from the first day of this study.
3) Patients who are obtained with the prior written consent.
Key exclusion criteria 1) Patients with food allergy
2) Patients less than 20 years old.
3) Patients judged to be inappropriate for this study from the doctor in charge.
Target sample size 15

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 and Alternative Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3498
Email kaz@cam.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Asuka Yasueda
Organization Osaka University Graduate School of Medicine
Division name Department of Complementary and Alternative Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3498
Homepage URL
Email a-yasueda@cam.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Takara Bio INC.
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
Address
Tel
Email

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 大阪大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 07 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
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 02 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 05 Month 02 Day
Last modified on
2017 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016184

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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