UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013590 |
|---|---|
| Receipt number | 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 09:20:27 |
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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 | Obstetrics 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
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
norikingyo@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015879
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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