UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of the efficacy and safety of Hainosankyuto on purulence in patients with lymphedema
Title of the study (Brief title)	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	Noriaki Sakuragi
Organization	Hokkaido University School of Medicine
Division name	Department of Obstetrics and Gynecology
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	Noriko Kobayashi
Organization	Hokkaido University Hospital
Division name	Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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