UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000848 |
|---|---|
| Receipt number | R000001018 |
| Scientific Title | The efficacy and safety of Kampo (Japanese herbal) medicines, maoto and maotokasekko, in treatment of influenza virus infections |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2009/07/03 16:43:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy and safety of Kampo (Japanese herbal) medicines, maoto and maotokasekko, in treatment of influenza virus infections
Acronym
The efficacy and safety of Kampo medicines in treatment of influenza virus infections
Scientific Title
The efficacy and safety of Kampo (Japanese herbal) medicines, maoto and maotokasekko, in treatment of influenza virus infections
Scientific Title:Acronym
The efficacy and safety of Kampo medicines in treatment of influenza virus infections
Region
| Japan |
Condition
Condition
influenza virus infections
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the efficacy and safety of maoto and maotokasekko in treatment of influenza virus infections
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
time to the alleviation of all major symptoms
definition of "alleviation of all major symptoms"
1. without sensation of heat
2. oral temperature is 37.8 degree C or lower
3. disappearance or mild state of all the symptoms below
1. sore throat
2. cough
3. muscle pain
4. headache
4. above state is kept more than 24 hours
Key secondary outcomes
time to the absence of fever
time to the alleviation of individual symptoms
time to the resumption of normal activities
adverse drug events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of maoto
consumption of 2 packs of maoto directly after the consultation, subsequent application of 2 packs after 4 and 8 hours and 1 pack after 16, 24, and 32 hours, respectively
Interventions/Control_2
administration of maotokasekko
consumption of 2 packs of maotokasekko directly after the consultation, subsequent application of 2 packs after 4 and 8 hours and 1 pack after 16, 24, and 32 hours, respectively
Interventions/Control_3
administration of oseltamivir (Tamiflu)
consumption of 1 capsule of Tamiflu 2 times a day, in the morning and the evening, for 5 days
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 virus infection who meet all the requirements below
1. oral temperature equal or higher than 37.8 degree C
2. two or more symptoms shown below
headache
muscle pain
cough
sore throat
3. within the first 36 hours after the onset of symptoms
4. identification of influenza virus by PCR methods
Key exclusion criteria
1. patients who is taking any Kampo medicines
2. patients who took any Kampo medicines in the past 4 weeks
3. patients who need to start taking other medicines simultaneously
4. patients with active cardiovascular diseases
5. patients with active hyperthyroidism
6. patients in danger of urinary retention
7. patients with severe delicate constitution
8. patients with hypokalemia
9. patients with significant liver or renal dysfunction
10. patients with allergic reaction to the test drugs
11. patients with some disease which may deteriorate their performance status such as cancer or heart failure
12. patients considered inappropriate for this trial by the physicians-in-charge
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Odaguchi |
Organization
Oriental Medicine Research Center, Kitasato University
Division name
Clinical Trial Division
Zip code
Address
5-9-1, Shirokane, Minatoku, Tokyo
TEL
03-3444-6161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Odaguchi |
Organization
Oriental Medicine Research Center, Kitasato University
Division name
Clinical Trial Division
Zip code
Address
5-9-1, Shirokane, Minatoku, Tokyo
TEL
03-3444-6161
Homepage URL
odaguchi@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Oriental Medicine Research Center, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Oriental Medicine Research Center, Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato Institute Hospital
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
| 2007 | Year | 11 | 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
| 2007 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 12 | Day |
Last modified on
| 2009 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001018
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
