UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031519 |
|---|---|
| Receipt number | R000035960 |
| Scientific Title | Clinical evaluation of the efficacy and safety of Hochuekkito for fatigue in patients with myeloproliferative neoplasms |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/06/10 15:02:02 |
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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
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
yedahiro@juntendo.ac.jp
Sponsor or person
Institute
Department of Hematology, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035960
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
