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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013590
Receipt No. R000015879
Scientific Title The evaluation of the efficacy and safety of Hainosankyuto on purulence in patients with lymphedema
Date of disclosure of the study information 2014/05/07
Last modified on 2018/01/29

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Basic information
Public title The evaluation of the efficacy and safety of Hainosankyuto on purulence in patients with lymphedema
Acronym The effect of Hainosankyuto on purulence in patients with lymphedema
Scientific Title The evaluation of the efficacy and safety of Hainosankyuto on purulence in patients with lymphedema
Scientific Title:Acronym The effect of Hainosankyuto on purulence in patients with lymphedema
Region
Japan

Condition
Condition Patients with lymphedema
Classification by specialty
Medicine in general Surgery in general Obsterics and gynecology
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety on purulence in patients with lymphedema and to explore the action mechanism by clinical pharmacological testing of Hainosankyuto
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of days to clear the symptoms of purulence
Key secondary outcomes 1)The severity of the symptoms of purulence 2)The body temperature 3)QOL questionnaire 4)The circumference of the region of lymphedema (the affected side) 5)Immunologic test [Measuring NK cell activity, balance between Th1 and Th2, and cytokine (TNF-alpha, IL-12)]

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TSUMURA Hainosankyuto Extract Granules for Ethical Use plus oral antibiotics for two weeks
Interventions/Control_2 oral antibiotics for two weeks
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria 1)Patients with lymphedema
2)Patients diagnosed grade 2 and more in lymphedema staging according to International Society of Lymphedema (ISL)
3)Patients with a first episode of purulence or who relapsed after over a year
4)Patients within 3 days after the onset of purulence
5)20-75 years of age
6)Sex: Female
7)Outpatient
8)Patients with written consent
Key exclusion criteria 1)Patients with aldosteronism, myopathy and hypokalemia
2)Patients who were prescribed Kampo medicine within 4 weeks before entry
3)Patients who were prescribed an adrenocortical hormonic agent or an anti-allergic agent
4)Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders)
5)Patients with recurrent or metastasized cancer
6)Pregnant patients, breast-feeding patients or patients hoping to become pregnant
7)Patients considered inappropriate by the study investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriaki Sakuragi
Organization Hokkaido University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL 011-706-5941
Email sakuragi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Kobayashi
Organization Hokkaido University Hospital
Division name Gynecology
Zip code
Address North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL 011-706-5941
Homepage URL
Email norikingyo@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University School of Medicine
Institute
Department

Funding Source
Organization TSUMURA & CO.
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
2014 Year 05 Month 07 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
2014 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 01 Day
Last modified on
2018 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015879

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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