Unique ID issued by UMIN | UMIN000001514 |
---|---|
Receipt number | R000001823 |
Scientific Title | Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza |
Date of disclosure of the study information | 2008/11/21 |
Last modified on | 2010/03/24 09:20:08 |
Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza
To explore and evaluate the efficacy and safety of Maoto for Influenza
Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza
To explore and evaluate the efficacy and safety of Maoto for Influenza
Japan |
Influenza Type A and Type B
Pneumology | Infectious disease |
Others
NO
To explore the efficacy of Maoto against Influenza by evaluating fever clearance time, residual viral load, symptom changes, and concurrently collecting data about its safety.
Safety,Efficacy
Exploratory
Phase IV
1. Symptoms of Influenza
1) fever clearance time
2) other symptoms (nasal discharge, nasal obstruction, sore throat, cough, muscle ache, arthralgia, lethargy or fatigue, headache)
1. Laboratory test for virus
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
65 | years-old | >= |
Male and Female
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 Diagnostic Test
3) Patients with influenza symptoms within 48 hours of onset
4) Age: between 20 - 65 y/o (at the time of acquisition of consent)
5) Gender: no specification
6) Consultation method: outpatient
7) Patients who can provide a written consent
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.)
100
1st name | |
Middle name | |
Last name | Norio Iwaki |
Iwaki internal medicine clinic
directer
2-5-20,Ekinishihonmachi Kanazawa-shi, Ishikawa-ken,Japan
076-223-2111
1st name | |
Middle name | |
Last name | Norio Iwaki |
Iwaki internal medicine clinic
directer
2-5-20,Ekinishihonmachi Kanazawa-shi, Ishikawa-ken,Japan
076-223-2111
niwaki@wish.ocn.ne.jp
TJ-27 Influenza study group
Tsumura & Co.
Profit organization
Japan
NO
2008 | Year | 11 | Month | 21 | Day |
Unpublished
Completed
2008 | Year | 09 | Month | 16 | Day |
2008 | Year | 11 | Month | 01 | Day |
2009 | Year | 05 | Month | 01 | Day |
2008 | Year | 11 | Month | 18 | Day |
2010 | Year | 03 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001823
Research Plan | |
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Research case data specifications | |
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Registered date | File name |
Research case data | |
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Registered date | File name |