UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018827 |
|---|---|
| Receipt number | R000021776 |
| Scientific Title | Effectiveness of complementary and alternative approaches to lifestyle diseases: a summary of systematic reviews |
| Date of disclosure of the study information | 2015/08/27 |
| Last modified on | 2021/09/21 10:45:02 |
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Basic information
Public title
Effectiveness of complementary and alternative approaches to lifestyle diseases:
a summary of systematic reviews
Acronym
Effectiveness of complementary and alternative approaches to lifestyle diseases
Scientific Title
Effectiveness of complementary and alternative approaches to lifestyle diseases:
a summary of systematic reviews
Scientific Title:Acronym
Effectiveness of complementary and alternative approaches to lifestyle diseases
Region
| Japan |
Condition
Condition
lifestyle diseases
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this review is to summarize the effectiveness of complementary and alternative or integrative approaches to lifestyle diseases. We will examine systematic reviews (SRs) based on randomized controlled trials (RCTs) and summarize the specific effectiveness of an intervention for each section of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) or the ICD-11.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Our main goal is to summarize the specific effectiveness of an intervention for each section of the ICD-10 or ICD-11. In addition, we will create an evidence frame work together with age and sex while we examine the validity and interpretation of each SR's result. We are also interested in the accuracy of the implementation and description of each SR. We will evaluate each claim report by the AMSTAR checklist (Shea BJ, et al., 2007).
Key secondary outcomes
We will not define the secondary outcomes.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Studies will be eligible if they are SRs based on all types of complementary and alternative approaches (i.e., interventions) to lifestyle diseases. This study will be a review based on SRs and will be restricted to original SRs of adult patients with six types of lifestyle diseases: hypertension, hyperlipidemia, type 2 diabetes, colon cancer, stroke, and obesity.
Key exclusion criteria
Not SR (i.e., narrative reviews)
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroharu |
| Middle name | |
| Last name | Kamioka |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environment Science
Zip code
1568502
Address
1-1-1Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2587
h1kamiok@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroharu |
| Middle name | |
| Last name | Kamioka |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environment Science
Zip code
1568502
Address
1-1-1Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2587
Homepage URL
h1kamiok@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research © Number 26350910 from the Ministry of Education, Culture, Sports, Science and Technology (MEXT),
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tokyo University of Tokyo
Address
1-1-1 Sakuragaoka, Setagaya-ku, Tokyo, Japan
Tel
0354772532
kakenhi@nodai.ac.jp
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
| 2015 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000021776
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/file/KAKENHI-PROJECT-26350910/26350910seika.pdf
Number of participants that the trial has enrolled
81
Results
This study revealed that there have been 81 SRs on lifestyle-related diseases, and product-based methods were more widely implemented than practice-based methods. Please refer to the research report above the URL.
Results date posted
| 2021 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable.
Participant flow
Not applicable.
Adverse events
Not applicable.
Outcome measures
Not applicable.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Review team
Professor Hiroharu Kamioka, Faculty of Regional Environment Science, Tokyo University of Agriculture
Professor Kiichiro Tsutani, Tokyo Ariake Medical and Health Science University
Prof. Koki Tsuruoka, Graduate School of Social Services, Japan College of Social Work
Dr. Takahiro Yoshizaki, Department of Nutritional Science, Department of Toyo University
Mr. Shinpei Okada, Physical Education and Medicine Research Foundation
Mr. Sang-jun Park, Physical Education and Medicine Research Foundation
Mr Jun Kitayuguchi, Physical Education and Medicine Research Center Unnan
Mr. Takafumi Abe, Physical Education and Medicine Research Center Unnan
Ms. Mikiko Shimada, Medical Cooperations Hidaka Rehabilitation Hospital
Contribution
HK designed the study. TY, SO, SP, JK, TA, MS, and HK will take responsibility for the quality assessment and summary of included studies and data extraction. KT and KT will be the guarantors. All authors will critically revise the manuscript for important intellectual content.
Pease see our complete protocol on the PROSPERO website. We described this protocol based on the PRISMA-P checklist.
Management information
Registered date
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021776
| 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 |
