UMIN-CTR Clinical Trial

Basic information
Public title	Clinical evaluation of the efficacy and safety of Hochuekkito for fatigue in patients with myeloproliferative neoplasms
Acronym	Hochuekkito for myeloproliferative neoplasms related fatigue
Scientific Title	Clinical evaluation of the efficacy and safety of Hochuekkito for fatigue in patients with myeloproliferative neoplasms
Scientific Title:Acronym	Hochuekkito for myeloproliferative neoplasms related fatigue
Region	Japan

Condition
Condition	myeloproliferative neoplasms
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy of Hochueekito for myeloproliferative neoplasms related fatigue
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MPN-SAF TSS at week 8
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hochuekkitou 7.5g/day for 8 weeks
Interventions/Control_2	No treatment
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Diagnosed as myeloproliferative neoplasms including polycythemia vera, essential thrombocythemia, primary myelofibrosis, and secondary myelofibrosis 2.Score >=3 in fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during past 24 hours of MPN-SAF TSS 3.20 years of age or older 4.Written informed consent 5.Capable of oral administration 6.No plan to change the treatment strategy because of stable disease
Key exclusion criteria	1.Severe complications including liver disease and respiratory disease 2.Alergy to chinese traditional medicine 3.Treated with other chinese traditional medicine within 2 weeks. 4.Participated to other clinical trials 5.Determined as inappropriate by the researcher
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoko Edahiro
Organization	Juntendo University School of Medicine
Division name	Department of Hematology
Zip code
Address	2-1-1 Hongou, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	yedahiro@juntendo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoko Edahiro
Organization	Juntendo University School of Medicine
Division name	Department of Hematology
Zip code
Address	2-1-1 Hongou, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	yedahiro@juntendo.ac.jp

Sponsor
Institute	Department of Hematology, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	Department of Hematology, Juntendo University School of Medicine Center for Advanced Kampo Medicine and Clinical Research, Juntendo Graduate School of Medicine
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	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	2018 Year 04 Month 01 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	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 02 Month 23 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 28 Day
Last modified on	2019 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035960