Non-randomized, multicenter, open, fixed-dose, single group, joint study to determine the efficacy and safety of Maoto for Influenza

UMIN ID: UMIN000001514

Registered date:21/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Influenza Type A and Type B
• Date of first enrollment: 2008/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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.)

Related Information

• Primary Sponsor: TJ-27 Influenza study group
• Source(s) of Monetary Support: Tsumura & Co.