UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012540
Receipt number R000014380
Scientific Title Assessment of A Decision Making Model Including Kampo Therapy for the Management of Influenza.
Date of disclosure of the study information 2013/12/20
Last modified on 2014/01/07 11:36:46

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Basic information

Public title

Assessment of A Decision Making Model Including Kampo Therapy for the Management of Influenza.

Acronym

Kampo Therapy Decision Making Model for Influenza.

Scientific Title

Assessment of A Decision Making Model Including Kampo Therapy for the Management of Influenza.

Scientific Title:Acronym

Kampo Therapy Decision Making Model for Influenza.

Region

Japan


Condition

Condition

Influenza like illness

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess a decision making model including Kampo therapy for the management of influenza.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Patients' choice of therapy (Primary outcome about medical cost)
Duration of fever (Primary outcome about effectiveness)

Key secondary outcomes

Change of therapy
Initial symptoms
Dose of antipyretics
Adverse event
Patients' satisfaction for treatment
Vaccination


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Neuraminidase inhibitors including osertamivir, zanamivir, and laninamivir

Interventions/Control_2

Kampo formula including maoto for patinets with sweating and makyokansekito for without sweating

Interventions/Control_3

watchful waiting

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with influenza like illness who meet all the requirements below
1. axilla temperature equal or higher than 38.0 degree C within the first 48 hours after the onset of fever

2. some symptoms shown below
chill
sore throat
cough
headache
muscle pain
multiple arthrargia
general fatigue

Key exclusion criteria

1. patients younger than 19 year-old or older than 65 year-old
2. patients with slight symptoms like subfever or running nose only
3. patients with severe symptoms which need hospitalization
4. persons with chronic pulmonary (including asthma), cardiovascular (except hypertension alone), renal, hepatic, hematological (including sickle cell disease), metabolic disorders (including diabetes mellitus), or neurologic and neurodevelopment conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability [mental retardation], moderate to severe developmental delay, muscular dystrophy, or spinal cord injury), and active hyperthyroidism
5. patients in danger of urinary retention
6. persons with immunosuppression, including that caused by medications or by HIV infection
7. women who are pregnant or postpartum (within 2 weeks after delivery)
8. persons who are morbidly obese (i.e., body-mass index is equal to or greater than 40)
9. residents of nursing homes and other chronic-care facilities
10. patients considered inappropriate for this trial by the physicians-in-charge including allergic reaction to the test drugs

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Mimura

Organization

Keio University School of Medicine

Division name

Center for Kampo Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5366-3824

Email

mimura@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuhiro Yoshino

Organization

Keio University School of Medicine

Division name

Center for Kampo Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5366-3824

Homepage URL

http://www.keio-kampo.jp/index.html

Email

tetta213@a5.keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kobe University Hospital
Jichi Medical University Hospital
Nishitaga National Hospital
Hiyoshi Medical Clinic
Irako Clinic
Ohi Kyodo Clinic
Kameda Medical Hospital
Ohsaki First Clinic
Saiseikai Central Hospital
Saiseikai Mukoujima Hospital
Kumamoto Red Cross Hospital

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

慶應義塾大学病院漢方医学センター (主幹施設:東京都)
神戸大学病院(兵庫県)
自治医科大学付属病院(栃木県)
国立病院機構西多賀病院漢方医学センター(宮城県)
日吉メディカルクリニック(神奈川県)
五十子クリニック(東京都)
大井協同診療所(東京都)
亀田総合病院(千葉県)
大崎ファーストクリニック(東京都)
東京都済生会中央病院(東京都)
東京都済生会向島病院(東京都)
熊本赤十字病院(熊本県)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 20 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

Terminated

Date of protocol fixation

2013 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 20 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

2013 Year 12 Month 10 Day

Last modified on

2014 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014380


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name