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Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine 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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001514
Enrollment
100
Registered
2008-11-21
Start date
2008-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Type A and Type B

Interventions

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

Sponsors

TJ-27 Influenza study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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

Exclusion criteria

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.)

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactNorio Iwaki

Iwaki internal medicine clinic directer

niwaki@wish.ocn.ne.jp076-223-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026