A non-blind, randomized, parallel group comparative trial to study the efficacy and safety of Mao-to in the treatment of influenza.

UMIN ID: UMIN000001653

Registered date:23/01/2009

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: 2009/01/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Test drug: Tsumura Mao-to extract granule for prescription Normal adult dose: 7.5g PO divided BID/TID before or between meals. Duration of administration: 5 days
Test drug: oseltamivir phosphate (product name: Tamiflu capsule 75) Standard dosage for adults and children with body weight of > 37.5kg: 1 cap (75mg) PO BID x 5 days.
Zanamivir (product name: Relenza) Standard dosage for adults and children: 10mg (5mg blisters of powders x 2) BID x 5 days on a ROTADISK® for oral inhalation via DISKHALER®.

Outcome(s)

• Primary Outcome: 1.Viral tests (1) Residual virus "Nasal swab" will be taken on Day 1, 3, and 5 (or discontinuation date) to conduct the following tests: (If sinuses are too dry for sample collection, throat swabs may be substituted. Day 6 samples will be accepted if subjects are not available or if a holiday coincides with Day 5.) * Viral isolation and identification (PCR) * Rapid diagnostic test for influenza (Day 3, Day 5 (or discontinuation date)) 2. Influenza symptoms (1) Time of fever clearance Instruct subjects to record their body temperature from the start date of administration (Day 1) to Day 5. Fever clearance time is measured as the time from drug administration until the reduction of body temperature below 37.5C. (If the temperature relapses above 37.5C, fever clearance time will be considered as the last time it took for the body temperature to drop below 37.5C). (2) Other symptoms Instruct subjects to keep a symptom diary from the start date of administration (Day 1) until Day 5 (or discontinuation date): * nasal discharge, nasal obstruction, sore throat, muscle ache, joint pain, malaise or fatigue, and headache. 3) Blood count, CRP and cytokine (1) Changes in cytokine levels Determine the blood count (WBC fraction), CRP, cytokine (IL-1, IL-6, IL-8, IL-10, TNF-a, IFNa2) levels in the blood from the start date (Day 1, prior to test drug administration), Day 3, and Day 5 (or discontinuation date).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1) Administration of Kampo medicine or any respiratory medication within 3 days prior to registration. 2) Administration of influenza vaccination within 2 weeks prior to registration. 3) Serious disease complication including, but not limited to: liver, kidney, heart, lung, circulatory, or metabolic disorder. 4) Suspicion of supervening bacterial infection of the respiratory tract. 5) History of drug allergies. 6) Females who are pregnant, lactating or planning pregnancy. 7) Administration of another investigational drug within 4 weeks prior to registration or during the study period, or planned participation in another study. 8) Contraindications to acetaminophen (peptic ulcer, aspirin-induced asthma, acetaminophen hypersensitivity). 9) Subjects who are unfit for the study as judged by the research director, research staff, or others (referred to as "research director and team")

Related Information

• Primary Sponsor: Fukuoka University Hospital
• Source(s) of Monetary Support: Tsumura & Co.