UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004551
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute University of Toyama
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.