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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012059
Receipt No. R000013944
Scientific Title Evaluation of effect of Propolis on CO2 output, urine pH and insulin resistance
Date of disclosure of the study information 2013/10/21
Last modified on 2015/04/17

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Basic information
Public title Evaluation of effect of Propolis on CO2 output, urine pH and insulin resistance
Acronym Propolis, CO2 output, urine pH and insulin resistance
Scientific Title Evaluation of effect of Propolis on CO2 output, urine pH and insulin resistance
Scientific Title:Acronym Propolis, CO2 output, urine pH and insulin resistance
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the effects of Propolis for acid output and insulin resistance in patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CO2 output, urine pH, HOMA-IR
Key secondary outcomes fasting plasma glucose, HbA1c, serum insulin, blood ketone body, total cholesterol, HDL. LDL, triglyceride, remnant lile particle cholesterol(RLP-C), uric acid

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
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Brazilian Propolis(450.0mg/day)
Interventions/Control_2 placebo
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
35 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who are able to give written informed consent
2) Age is over 35 years and less than 75 years
3) Type of practice: outpatient department
4) Patients are able to do the following things in this trial - getting good compliance with consuming investigational food and coming to hospital
Key exclusion criteria 1) Patients who did not agree with this study
2)Patients with severe renal dysfunction and severe hepatic dysfunction
3)Pregnant women, women who may be pregnant, and breast-feeding women
4)Patients treated with insulin
5)Patients judged by the investigator to be ineligible for some other reason
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Fukui
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL +81-75-251-5505
Email sayarinapm@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Fukuda
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL +81-75-251-5506
Homepage URL
Email fukudatakuya0720@gmail.com

Sponsor
Institute Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

Funding Source
Organization Yamada Apiculture Center Inc. (Okayama, Japan)
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

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 21 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
2013 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 21 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 08 Month 31 Day
Date trial data considered complete
2014 Year 10 Month 05 Day
Date analysis concluded
2014 Year 10 Month 05 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 17 Day
Last modified on
2015 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013944

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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