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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010613
Receipt No. R000012410
Scientific Title Competitive study to examine the effectiveness of hochuekkito for patients with serious skin wound
Date of disclosure of the study information 2013/04/30
Last modified on 2019/01/24

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Basic information
Public title Competitive study to examine the effectiveness of hochuekkito for patients with serious skin wound
Acronym Effectiveness of hochuekkito for patients with serious skin wound
Scientific Title Competitive study to examine the effectiveness of hochuekkito for patients with serious skin wound
Scientific Title:Acronym Effectiveness of hochuekkito for patients with serious skin wound
Region
Japan

Condition
Condition serious skin wound
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of hochuekkito for patient with serious skin wound in randomized controlled trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cure of wound
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Kampo medications(hochuekkito)
Interventions/Control_2 control
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria No wound healing for more than 3 weeks
Key exclusion criteria Patients
1 who is impossible to take hochuekkito
2 who takes other herbal medicines regularly
3 who has interstitial pneumonia and /or pseudo-aldosteronism
4 who is recognized to be inappropriate as a subject
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Namiki
Organization Chiba University hospital, chiba University
Division name Dept. of Japanese-Oriental(Kampo) and Dept. of plastic surgery
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba-city
TEL 043-226-2984
Email tnamiki@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Namiki
Organization Chiba University hospital, chiba University
Division name Dept. of Japanese-Oriental(Kampo)
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba-city
TEL 043-226-2984
Homepage URL
Email tnamiki@faculty.chiba-u.jp

Sponsor
Institute Takao Namiki
Dept. of Japanese-Oriental(Kampo) Medicine,
Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Dept. of Japanese-Oriental(Kampo) Medicine,
Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 G24030
Org. issuing International ID_1 ChibaUniversity
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 04 Month 30 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
18 patients divided into medication (7.5 g oral Kampo medicines per day, n = 9) and control (n = 9) groups. Wound healing during the 12-week study period was scored based on depth, exudate, size, inflammation/infection, granulation tissue, necrotic tissue, and pocket size. Wound healing was observed at 12 weeks in all nine patients in the medication group, whereas wound healing progressed in only three in the control group (significant difference, P < 0.01; odds ratio, 3.00). In the medication group, the total score decreased significantly at 8 weeks and later. To our knowledge, this study showed for the first time that HET promoted healing of chronic wounds resistant to conventional treatments.
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
2012 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 15 Day
Date analysis concluded
2018 Year 12 Month 28 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 30 Day
Last modified on
2019 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012410

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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