Influenza Type A and Type B
Conditions
Interventions
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 phosphat
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&
reg
for oral inhalation via DISKHALER&
Sponsors
Fukuoka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Positive rapid diagnostic test for influenza. 2) Fever >= 38.0C upon admission, or fever >= 37.5C upon admission with a history of fever >= 38.0C within 4 hours prior to admission. 3) Within 48 hours after onset of influenza symptoms. 4) Age: between 20-65 yrs (at the time of signing informed consent) 5) Gender: unspecified 6) Consultation method: outpatient 7) Provision of a signed informed consent.
Exclusion criteria
Exclusion 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")
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Outcome results
None listed