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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003366
Receipt No. R000004091
Scientific Title Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza Type A
Date of disclosure of the study information 2010/03/24
Last modified on 2010/11/01

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Basic information
Public title Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza Type A
Acronym To explore and evaluate the efficacy and safety of Maoto for Influenza Type A
Scientific Title Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza Type A
Scientific Title:Acronym To explore and evaluate the efficacy and safety of Maoto for Influenza Type A
Region
Japan

Condition
Condition Influenza Type A
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the efficacy of Maoto against Influenza Type A by evaluating fever clearance time, residual viral load, symptom changes, and concurrently collecting data about its safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes 1) Symptoms of Influenza
a.fever clearance time
b.other symptoms (nasal discharge, nasal obstruction, sore throat, cough, muscle ache, arthralgia, lethargy or fatigue, headache)
2) Laboratory test for virus
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Test drug: Tsumura Mao-to extract granule for prescription
Normal adult dose is 7.5g p.o. in 2-3 divided doses, before or between meals.
Duration of administration: 5 days
Interventions/Control_2
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
10 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with a fever >38.0C or >37.5C at the time of admission, or >38.0C within 4 hours of admission
2) Patients who tested positive on Rapid Influenza Type A Diagnostic Test
3) Patients with influenza symptoms within 48 hours of onset
4) Age: between 10 - 65 y/o (at the time of acquisition of consent)
5) Gender: no specification
6) Consultation method: outpatient
7) Patients who can provide written informed consent ,if the patient is a minor, informed consent must be obtained from the patient and legal representative.
Key exclusion criteria 1) Patients who were taking Kampo or medication for respiratory disease within 3 days of registration
2) Patients who obtained an influenza vaccination within 2 weeks of registration
3) Patients with serious complications (liver, kidney, heart, lung, circulatory, or metabolic disorder)
4) Patients suspected of concomitant bacterial infection of the respiratory system
5) Patients with a history of drug allergy
6) Patients who are nursing, pregnant or desiring conception
7) Patients who are currently taking a test drug or planning to partake in a clinical trial
8) Patients with contraindication for acetaminophen (peptic ulcer, aspirin-induced asthma, acetaminophen hypersensitivity)
9) Patients who are considered inappropriate by the research director, research staff, or others (referred collectively as research director, etc.)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Iwaki
Organization Iwaki internal medicine clinic
Division name directer
Zip code
Address 2-5-20,Ekinishihonmachi Kanazawa-shi, Ishikawa-ken,Japan
TEL 076-223-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norio Iwaki
Organization Iwaki internal medicine clinic
Division name directer
Zip code
Address 2-5-20,Ekinishihonmachi Kanazawa-shi, Ishikawa-ken,Japan
TEL 076-223-2111
Homepage URL
Email iwaki@po2.nsknet.or.jp

Sponsor
Institute TJ-27 Influenza study group
Institute
Department

Funding Source
Organization Tsumura & Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 群馬県、石川県、岐阜県、徳島県、熊本県、兵庫県

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 24 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
2009 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 24 Day
Last modified on
2010 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004091

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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