UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004551 |
|---|---|
| Receipt number | R000005439 |
| Scientific Title | A comparative trial of Kampo formulas on insulin resistance and endothelial function |
| Date of disclosure of the study information | 2010/11/15 |
| Last modified on | 2012/06/13 10:14:00 |
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Basic information
Public title
A comparative trial of Kampo formulas on insulin resistance and endothelial function
Acronym
Effect of Kampo formulas on endothelial function
Scientific Title
A comparative trial of Kampo formulas on insulin resistance and endothelial function
Scientific Title:Acronym
Effect of Kampo formulas on endothelial function
Region
| Japan |
Condition
Condition
Rheumatoid arthritis or metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of Kampo formulas on endothelial function in patients with rheumatoid arthritis or metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The levels of peripheral arterial tonometry
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of keishibukuryogan
Interventions/Control_2
Non-administration of keishibukuryogan
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with rheumatoid arthritis.
2. Patients with factors of metabolic syndrome (obesity, elevation of blood pressure, lipid abnormality, hyperglycemia etc.).
Key exclusion criteria
1. Patients with inflammatory diseases (except rheumatoid arthritis), cancer or other serious disorders.
2. Patients who changed addiction medicines within three months.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirozo Goto |
Organization
University of Toyama
Division name
Department of Japanese Oriental Medicine, Graduate school of Medicine and Pharmaceutical Sciences
Zip code
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-7393
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Nagata |
Organization
University of Toyama
Division name
Department of Japanese Oriental Medicine, Graduate school of Medicine and Pharmaceutical Sciences
Zip code
Address
2630 Sugitani, Toyama, Japan
TEL
076-434-7393
Homepage URL
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
富山大学附属病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.hindawi.com/journals/ecam/2012/359282/
Publication of results
Published
Result
URL related to results and publications
http://www.hindawi.com/journals/ecam/2012/359282/
Number of participants that the trial has enrolled
Results
Ninety-two patients were assigned to group A (first KBG-treatment period, then control period; each lasting 4 weeks, with about a one-year interval) or group B (first control, then KBG-treatment). In forty-nine (27, group A; 22, group B) patients completing all tests, the mean value of the natural logarithmic scaled reactive hyperemia index (L_RHI) increased and those of serum non-esterified fatty acid (NEFA), malondialdehyde and soluble vascular cell adhesion molecule 1 decreased significantly during the KBG-treatment period, but not during the control period, and 4-week changes of L_RHI, NEFA and malondialdehyde between the 2 periods showed significance. These results suggest that KBG has beneficial effect on endothelial function in patients with metabolic syndrome-related factors.
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
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 12 | Day |
Last modified on
| 2012 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005439
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
