The efficacy and safety of Kampo (Japanese herbal) medicines, maoto and maotokasekko, in treatment of influenza virus infections

UMIN ID: UMIN000000848

Registered date:01/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: influenza virus infections
• Date of first enrollment: 2007/11/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

administration of maoto consumption of 2 packs of maoto directly after the consultation, subsequent application of 2 packs after 4 and 8 hours and 1 pack after 16, 24, and 32 hours, respectively
administration of maotokasekko consumption of 2 packs of maotokasekko directly after the consultation, subsequent application of 2 packs after 4 and 8 hours and 1 pack after 16, 24, and 32 hours, respectively
administration of oseltamivir (Tamiflu) consumption of 1 capsule of Tamiflu 2 times a day, in the morning and the evening, for 5 days

Outcome(s)

• Primary Outcome: time to the alleviation of all major symptoms definition of "alleviation of all major symptoms" 1. without sensation of heat 2. oral temperature is 37.8 degree C or lower 3. disappearance or mild state of all the symptoms below 1. sore throat 2. cough 3. muscle pain 4. headache 4. above state is kept more than 24 hours
• Secondary Outcome: time to the absence of fever time to the alleviation of individual symptoms time to the resumption of normal activities adverse drug events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. patients who is taking any Kampo medicines 2. patients who took any Kampo medicines in the past 4 weeks 3. patients who need to start taking other medicines simultaneously 4. patients with active cardiovascular diseases 5. patients with active hyperthyroidism 6. patients in danger of urinary retention 7. patients with severe delicate constitution 8. patients with hypokalemia 9. patients with significant liver or renal dysfunction 10. patients with allergic reaction to the test drugs 11. patients with some disease which may deteriorate their performance status such as cancer or heart failure 12. patients considered inappropriate for this trial by the physicians-in-charge

Related Information

• Primary Sponsor: Oriental Medicine Research Center, Kitasato University
• Secondary Sponsor: Kitasato Institute Hospital
• Source(s) of Monetary Support: Oriental Medicine Research Center, Kitasato University